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Confidentiality {27} | infection, fainting, bruising, pain | INFECTION | All participants will go through an informed consent process. The study staff will provide information for those who are interested in being tested but not interested in study participation. All potential clients will read or have read to them the consent form. The consent form will be available in both the local language and English, and participants will select which language they prefer to be consented in. Each participant will be given an opportunity to ask questions about study participation. If a participant agrees to participate in the study, the study staff will obtain electronic consent, with paper consents as a backup in case of electronic devices not being available. After consenting to participate, a participant may voluntarily withdraw from the study at any time and can choose not to have his/her responses submitted to the study team. Staff have undergone training on confidentiality, couple counseling, and testing and have substantial experience conducting VCT and home HTC. All staff members sign confidentiality agreements. For pre-screening, risks are associated with loss of confidentiality and finger-stick blood collection, including pain, fainting, and rarely, infection or bruising. The risk of loss of confidentiality is minimized due to participant control over the decision of where and when to test using self-administered kits. HIV self-administered testing has been shown to be highly acceptable in other settings in sub-Saharan Africa. However, as with all HIV testing, psychological distress is a risk for individuals who test positive for HIV. Since self-administered testing may be done alone by the participant, lack of immediate support and interpretation of results may contribute to distress. Pre-screening self-testing kits will include contact details to study staff for post-screening counseling (to return for either in-person or text message/telephonic support). Study staff will be available to provide counseling and referral to minimize psychological distress following self-administered pre-screening. | PMC9842495 |
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | To ensure the confidentiality of participants, all data will be coded by subject number. Data recorded on paper will be kept in locked cabinets with access only by members of the research team. There will be strict limited access to electronically stored data as well, using password protection. Research records will be kept confidential following national regulations. The subject’s name or other personal identifiers will not be included with specimens sent to the laboratory, which will be identified only by a code number. Interviewers and support staff will be trained on procedures for maintaining confidentiality. Text messages will be neutral and not contain information about the participant’s HIV status, e.g., appointment reminders will say “Your appointment is on Tuesday at 3pm”. At each visit, staff will ask about social harms, complete a detailed report, link the participant to community resources for support, and report social harms to the ethics review board. If multiple social harms are observed, the study procedures and text message content will be reviewed by the study team and community advisory boards and recommended changes submitted to regulatory bodies for review.The recorded in-depth interviews will be transcribed and, for interviews conducted in isiZulu, then translated to English. As part of the transcription and translation, investigators will delete any identifying information to ensure the final transcripts protect confidentiality. Recordings will be stored in password-protected files on a secure, firewalled server at the HSRC and the study site in South Africa. Only the research team, the translator, and the transcriptionist will be permitted access. | PMC9842495 |
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Statistical methods | PMC9842495 |
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Statistical methods for primary and secondary outcomes {20a} | Statistical analysis is summarized below. Additional details will be provided in a statistical analysis plan (SAP) prior to the analysis of the trial data. | PMC9842495 |
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Primary outcome | viral suppression | REGRESSION | We will assess the contribution of lottery incentives to the primary outcome of viral suppression after 18 months by comparing outcomes for individuals in two of the embedded adaptive interventions—(i) start with best clinic practices and continue for 18 months and (ii) start with best clinic practices plus lottery incentives and continue for 18 months—in a logistic regression model adjusted for age and sex. The study subjects who inform this comparison are those who are virally suppressed at 6 months and those who are not virally suppressed at 6 months but are randomized to continue in their baseline treatment. Following Nahum-Shani et al. [We will assess the relative contributions of home- and community-based ART treatment to the primary outcome of viral suppression by comparing outcomes for individuals not virally suppressed after 6 months who are randomized to these two interventions in the second stage. We will estimate the odds ratio comparing the effectiveness of these two interventions relative to clinic-based care using multivariate logistic regression adjusted for age and sex. Subjects with baseline clinic-based interventions that do and do not include lottery incentives will be combined. For all analyses, we will estimate odds ratios, 95% confidence intervals, and | PMC9842495 |
Secondary outcomes | viral suppression | REGRESSION, SECONDARY | The same analyses as outlined for the primary outcome of viral suppression will be repeated for the secondary outcomes of retention in care (defined as the proportion of clinical visits and medication refills missed over the last 12 months of the intervention) and time to ART initiation, where logistic regression will be replaced by linear regression and Cox proportional hazards analysis, respectively. | PMC9842495 |
Testing for non-inferiority in addition to superiority | HIV viral suppression | SECONDARY | We hypothesize that community-based/home ART initiation will be acceptable and have a higher or comparable impact on the clinical outcome of HIV viral suppression compared to the standard clinic ART delivery model. For primary and secondary outcomes, we will first test for superiority. If the intervention is superior, the analysis will stop. If the intervention is not superior, we will test for non-inferiority with a conservative non-inferiority margin of 5%. | PMC9842495 |
Interim analyses {21b} | ADVERSE EVENTS | Interim analyses will include summaries of demographic data and whether participants were living with HIV who have a detectable viral load at enrollment or were not engaged in care at baseline. We will also summarize the numbers of adverse events and individuals lost to follow-up. All summaries will be conducted overall and broken down by randomization group (first- and second-stage randomization). These summaries will be calculated at times that align with meetings of the DSMB and will be shared with the DSMB. Aside from group-specific information about adverse events and loss to follow-up, summaries will also be shared with the SMART ART investigator team. Operational futility will be monitored to ensure trial resources are not squandered. | PMC9842495 |
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Methods for additional analyses (e.g., subgroup analyses) {20b} | viral suppression | REGRESSION, SECONDARY | We will conduct subgroup analyses for the primary and secondary outcomes where we separate individuals living with HIV who have a detectable viral load at enrollment and individuals not engaged in care at enrollment. We will conduct further subgroup analyses for all primary and secondary outcomes restricted to male/female participants and restricted to participants older/younger than 40 years. We will use product term interaction models to determine if there are statistically different associations between the outcomes based on sex or age.An exploratory analysis will estimate the clinic-specific rates of viral suppression and retention in care using multivariate logistic and linear regression models, respectively, with dummy variables for clinic and adjusted for age and sex in order to assess clinic heterogeneity. We will derive clinic-specific point estimates and 95% confidence intervals and will also calculate overall | PMC9842495 |
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} | The primary analysis will be modified intent-to-treat (mITT) restricted to participants who are not lost to follow-up and have complete endpoint data at the 18-month follow-up (inclusion in the mITT analysis will be determined separately for each outcome). As a sensitivity study, we will repeat all analyses as intent-to-treat (ITT), including all randomized participants and imputing missing endpoint data as follows: (i) individuals lost to follow-up will be assumed not to be virally suppressed, (ii) individuals lost to follow-up prior to initiating ART will be assumed to have never initiated ART, and (iii) for individuals lost to follow-up, the proportion of missed clinic visits and medication follow-ups will be calculated for all available months in the final 12 months of follow-up and will be assumed to be one in the remaining months. | PMC9842495 |
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Plans to give access to the full protocol, participant-level data, and statistical code {31c} | Using a data sharing platform, a complete dataset with patient identifies removed that is sufficient to reproduce the study findings will be made available approximately 1 year after completion of the trial. To gain access, a concept sheet summarizing the analyses to be done will first need to be submitted to the principal investigators for review. Further inquiries can be directed to the SMART ART Scientific Committee at [email protected]. | PMC9842495 |
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Oversight and monitoring | PMC9842495 |
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Composition of the coordinating center and trial steering committee {5d} | The SMART ART study will be jointly led by Harvard University and the Center for Community Based Research, Human Sciences Research Council of South Africa. | PMC9842495 |
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Composition of the data monitoring committee, its role, and reporting structure {21a} | viral suppression | ADVERSE EVENTS | We will constitute a Data Safety and Monitoring Board (DSMB) who will meet every 6 months to review the available study data. The analysis will evaluate participant safety (SAEs and social harms) and available endpoint data and review the operational factors, specifically participant enrollment and follow-up, to assess safety and study execution. To examine whether the study design should be modified, we will conduct a conditional power analysis of the process outcomes (ART uptake and adherence) and early endpoint data (viral suppression) to assess the futility for each of the two treatment groups. We will compare the frequency of ART-related SAEs between the three study groups to assess safety, and review the serious adverse events to see if any could be prevented. | PMC9842495 |
Adverse event reporting and harms {22} | nausea and vomiting, tuberculosis, gastrointestinal disturbance | OPPORTUNISTIC INFECTIONS, ADVERSE EVENTS, TUBERCULOSIS, STIS, ADVERSE EFFECTS, ADVERSE EVENT, EVENTS | All participants who experience adverse events will receive follow-up until the adverse event is resolved. The SMART ART study clinical monitor, based at the University of Washington Coordinating Center, will review all severe (grade 3/4) and serious adverse events to ensure follow-up and reporting. Serious adverse events (SAEs) will be documented and reported to involved regulatory bodies per their regulations. Serious adverse events will also be reported to the UW ICRC Coordinating Centre Clinical Monitor, who will track the events until resolved. SAE reports will be reviewed to determine if the SAE could have been avoided.Participants who initiate ART and who will collect ART refills from the mobile van will receive a phone call 1 week and 30 days after ART initiation to enquire about adverse events and refer participants to the clinic for evaluation if necessary. During participant ART resupply and monitoring visits, they will complete a standardized symptom screening questionnaire for adverse effects of ART, tuberculosis, opportunistic infections, and STIs. Furthermore, all participants on TDF/FTC or 3TC/EFV will receive the standard ART screening, including a creatinine test to monitor their renal function, at mobile van visits. Clinical side effects of TDF/FTC or 3TC/EFV include gastrointestinal disturbance (nausea and vomiting) and vivid dreams. Participants will be referred to the clinic for symptoms or signs requiring further investigation and/or treatment. We have established relationships with the clinics who expect to see study participants.All cases of social harm for participants will be documented. To ensure we are aware of all cases of adverse events associated with HIV results, we will ask each participant specifically about any social harm experienced as a result of learning HIV results at the follow-up visits. Staff will gather additional information about social harm for reports. Study staff are well versed in community-based organizations where individuals and couples can access on-going psychological support and help in case of gender violence and will provide information about these organizations to individuals and couples as needed. In addition to providing specific counseling, staff will refer participants for support to local organizations. The study teams have trained staff able to handle crisis situations due to couple conflict or difficulties in coping with positive HIV test results. | PMC9842495 |
Frequency and plans for auditing trial conduct {23} | RECRUITMENT | The project management group will meet weekly to review key metrics including balanced randomization, screen to enrollment rate, weekly recruitment, and retention rates. This team will be supported by a Data Safety and Monitoring Board (DSMB) and Institutional Review Board (IRB). The DSMB will meet annually for about 2 h per meeting with additional time for review of the DSMB report prior to the meeting. The IRB require that the study comply with ICH-GCP guidelines and provide annual review and renewal. | PMC9842495 |
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Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25} | RECRUITMENT | Modifications to study protocol, informed consent forms, and recruitment materials will all be submitted for review to both the HSRC and Harvard IRBs. The study will be reviewed annually by both IRBs when relevant information about recruitment, enrolment, follow-up, AEs and SAEs, and protocol deviations and violations are submitted as a unified report. | PMC9842495 |
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Dissemination plans {31a} | TRANSMISSION | Our team of investigators is fully committed to rapid and multi-pronged dissemination of study results, regardless of the results. Through our previous HIV prevention trials (HPTN 039, Partners in Prevention HSV/HIV Transmission Study, and Partners PrEP Study), we have found that community and stakeholder consultations are important at every stage of the research, spanning study concept to results, in order to build and sustain trust in research and research partnerships. Once results are available, we will provide timely results to the Umgungundlovu District and KZN Province in South Africa community stakeholders, South African Department of Health officials, and South African PEPFAR leadership. Once the study analysis is complete, data will be presented at local and international conferences and will be submitted for publication. | PMC9842495 |
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Discussion | death, DSD, viral suppression | DISEASE | Globally, more than half of the world’s 37 million people living with HIV are on antiretroviral therapy (ART) representing immense and encouraging success with access to HIV care. ART prevents disease, death, and HIV transmission and HIV-positive persons can expect to live as long as their HIV-negative peers when their viral load is undetectable. However, treatment success still lags behind goals. In South Africa alone, 8 million HIV-positive persons require ART for life and only 4.5 million are currently on ART. Patient barriers to care, such as missed wages, transport costs, and long wait times for clinic visits and ART refills, are associated with detectable viral load, the hallmark of struggling to access and take ART. HIV differentiated service delivery (DSD) has simplified ART delivery: incentives, multi-month scripts, fast-track ART, and community or home ART delivery motivate clients, reduce the frequency of clinic visits, and decongest clinics. DSD is standard for clients who achieve viral suppression and engage in care; however, DSD needs adaptation to serve clients who are not succeeding. Indeed, persons who are not engaged in care arguably need simplified, client-centered approaches even more than those who can successfully engage.This study will build on the investment, experience, results, and strong partners established through the Lotto-to-Link, DO ART, and Deliver Health Studies and test the impact of adaptive strategies for persons not suppressed on ART/not engaged in care, in sequence, to best clinic practices with or without lottery incentives, community-based ART, and home delivery. A suite of adaptive DSD strategies, including community-based ART, have been tested among stable clients with viral suppression. Lottery incentives effectively change short-term behavior, increasing ART initiation. Community and home ART delivery increases ART coverage and simplifies ART access overcoming clinic barriers. For stable clients, these DSD activities are as effective as clinic-based care in terms of achieving and maintaining viral suppression, although among stable clients they have not shown superiority in viral suppression or cost savings. In contrast, DSD has the potential to improve rates of viral suppression and retention in care and save costs among more hard-to-reach groups. There is great potential that DSD systems can be client-responsive and system-efficient for subgroups requiring additional services, matching services with client needs.A sequential, comprehensive package of DSD approaches, with each step increasing the intensity of service provision—adaptive DSD—has not been tested to determine the proportion and characteristics of persons who would achieve viral suppression and retention in care and to estimate the cost-effectiveness and budget impact. A Sequential Multiple Assignment Randomized Trial (SMART) design facilitates the evaluation of a stepped, adaptive approach to achieving viral suppression with “right-sized” interventions Adapting ART delivery and support interventions will require buy-in from clients and providers to understand what works and why. Clinic services are changing to become more welcoming to clients re-engaging in care. Through this study, we will generate evidence on which strategies increase viral suppression. | PMC9842495 |
Trial status | RECRUITMENT | This protocol references version 1.2 from July 9, 2021. The first participant was screened on November 3, 2021. The first participant was enrolled on November 10, 2021. The study is expected to conclude recruitment on April 24, 2023, with all enrolled participants followed quarterly for 18 months thereafter. | PMC9842495 |
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Acknowledgements | This study would not be possible without the participants who agree to take part in this SMART trial, the hard work of the SMART ART study team (Xolani Ntinga—study coordinator; Thulani Ngubane—community programs and stakeholder manager; Phil Joseph—operations manager; Bomikazi Mthembu—data collector; Sive Sikhakhane—data collector; Nompilo Mtolo—study nurse; Nokukhanya Cele—intervention facilitator; Nomalungelo Ntombela—intervention facilitator; Sinothile Cele—study nurse; Nondumiso Dangazele—data collector; Simphiwe Nzimande—recruiter driver; Xolani Qwabe—recruiter driver). | PMC9842495 |
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Authors’ contributions {31b} | ZE, AVH | RB and AVH conceived the study, led the proposal, and contributed to the protocol development. HVR, CC, and ZE contributed to the study design and development of the proposal. XN contributed to the development of protocol operation procedures. AS was the lead trial methodologist. The authors read and approved the final manuscript. | PMC9842495 |
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Funding {4} | Funding for this study was obtained from the US National Institutes of Health (R01MH124465T). | PMC9842495 |
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Availability of data and materials {29} | Listed investigators have full access to the final dataset. The final dataset will be curated and made available on request. | PMC9842495 |
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Declarations | PMC9842495 |
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Ethics approval and consent to participate {24} | Ethics approval was received from all relevant authorities in South Africa including the Human Sciences Research Councils Research Ethics Committee (REC 6/19/05/21) and the Department of Health (KZ_202108_020). In the USA, IRB approval was obtained (STUDY00013492). Written informed consents to screen and enrol will be obtained from all participants. | PMC9842495 |
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Consent for publication {32} | Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. Informed consent materials are from the corresponding author on request. | PMC9842495 |
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Competing interests {28} | The authors declare that they have no competing interests | PMC9842495 |
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References | PMC9842495 |
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Abstract | PMC10028033 |
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Background | cancer, depression, anxiety | CANCER | Parents of children treated for cancer may experience mental health difficulties, such as depression and anxiety. There is a lack of evidence‐based psychological interventions for parents, with psychological support needs unmet. An internet‐administered, guided, low‐intensity cognitive behavioral therapy‐based (LICBT) self‐help intervention may provide a solution. | PMC10028033 |
Methods | RECRUITMENT | The feasibility and acceptability of such an intervention was examined using a single‐arm feasibility trial (ENGAGE). Primary objectives examined: (1) estimates of recruitment and retention rates; (2) feasibility and acceptability of data collection instruments and procedures; and (3) intervention feasibility and acceptability. Clinical outcomes were collected at baseline, post‐treatment (12 weeks), and follow‐up (6 months). | PMC10028033 |
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Results | The following progression criteria were met: sample size was exceeded within 5 months, with 11.0% enrolled of total population invited, study dropout rate was 24.0%, intervention dropout was 23.6%, missing data remained at ≤10% per measure, and no substantial negative consequences related to participation were reported. Intervention adherence was slightly lower than progression criteria (47.9%). | PMC10028033 |
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Conclusion | cancer | CANCER, MINOR, RECRUITMENT, CHILDHOOD CANCER | Findings suggest an internet‐administered, guided, LICBT self‐help intervention may represent a feasible and acceptable solution for parents of children treated for cancer. With minor study protocol and intervention modifications, progression to a pilot randomized controlled trial (RCT) and subsequent superiority RCT is warranted.A single‐arm feasibility trial showed overall acceptability and feasibility of an internet‐administered, guided, low‐intensity cognitive behavioral therapy intervention for parents of childhood cancer survivors, and progression criteria were met for recruitment, retention, missing data, and harms, indicating methods, study procedures, and the overall the trial and intervention was feasible and acceptable. However, completion of assessments at each timepoint and intervention adherence were under progression criteria, meaning some modifications to the study protocol intervention are required before commencing a pilot randomized controlled trial.
Ella Thiblin and Joanne Woodford joint first authorship. | PMC10028033 |
INTRODUCTION | cancer | CANCER, CHILDHOOD CANCER | Advances in cancer treatment have resulted in increased childhood cancer survival rates worldwide.Solutions to increase access to psychological interventions are being implemented globally,A program of phase I (development) research, following the Medical Research Council complex interventions framework | PMC10028033 |
MATERIALS AND METHODS | The study protocol is published | PMC10028033 |
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Study design | EJDeR | A single‐arm feasibility trial of a guided, internet‐administered LICBT‐based intervention (EJDeR), with data collected at baseline, post‐treatment (12 weeks), and follow‐up (6 months) with an embedded mixed‐methods process evaluation. EJDeR is delivered via the U‐CARE‐portal (Portal), a web‐based platform, designed to deliver internet‐administered interventions and support the execution of study procedures. | PMC10028033 |
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Participants | CHILDHOOD CANCER | Eligible participants were: (1) parent of a child diagnosed with childhood cancer (0–18 years) who completed treatment 3 months to 5 years previously (timespan informed by our previous longitudinal research that has identified this as a time period of vulnerability for parents) | PMC10028033 |
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Recruitment | PMC10028033 |
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Postal study invitations | CHILDHOOD CANCER, RECRUITMENT | Personal identification numbers of children who had completed treatment 3 months to 5 years previously were provided by the Swedish Childhood Cancer Registry (CCR), and linked to parents' names and addresses via NAVET, a population registry from the Swedish Tax Agency. The first recruitment block was pre‐selected with parents of children who had ended treatment near to 5 years previously. The following four blocks were randomly selected by a member of the Portal team, independent to the research team, using a computer‐generated simple randomization procedure. Postal study invitation packs, sent to parents' home addresses, included a: (1) study invitation letter; (2) study information sheet and link to a secure website on the Portal (information in text and video format); (3) paper reply‐slip to register interest in participation; (4) paper‐based opt‐out form and reasons for non‐participation questionnaire; and (5) freepost envelope. Parents could register interest in participation and request more study information via the Portal, post, telephone or e‐mail. ENGAGE included an embedded recruitment RCT, investigating the effect of personalized versus non‐personalized study invitations on recruitment and retention | PMC10028033 |
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Online advertisements | cancer | CANCER | Advertisements were placed on social media sites, websites, and newsletters of 12 cancer organizations and interest groups. | PMC10028033 |
Opt‐out and reminders | Parents invited via the post could opt‐out of ENGAGE via the Portal, post, telephone, or e‐mail. Up to five reminder telephone contact attempts were made if parents did not respond within 4 weeks of invitation. Telephone numbers were identified using internet search engines. Contact attempts were documented in paper‐based case report forms (CRFs). If a telephone number was not identified, a postal study invitation reminder letter was sent. | PMC10028033 |
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Reasons for non‐participation | Parents opting out of ENGAGE were asked to complete a reason for non‐participation questionnaire including a closed, multiple choice question and an open question for other reason(s). | PMC10028033 |
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Consent, eligibility, and baseline | PTSS, Anxiety, psychiatric, Stress Disorder, Depression, Fatigue | DISORDER, RECURRENCE, DISORDERS | Parents provided consent via the Portal. Parents who registered interest in participation but did not provide consent, or opt out, within 2 weeks, were contacted to confirm interest in participation (maximum five reminders via telephone, SMS or e‐mail).Parents providing consent were contacted to organize a telephone eligibility interview with a licensed psychologist. Interviews included: (1) questions concerning eligibility criteria; with those eligible completing specific modules of the M.I.N.I., and; (2) questions concerning parent and child sociodemographic and clinical characteristics (Table Overview of measures taken at respective assessment time‐pointPortal/TelephoneWeekly process evaluation: Portal onlyPortal/TelephoneWeekly process evaluation: Portal onlyPortal/TelephoneWeekly process evaluation: Portal onlyPortal/TelephoneWeekly process evaluation: Portal onlyPortal/TelephoneWeekly process evaluation: Portal onlyAbbreviations: AAQ‐6, Acceptance and Action Questionnaire; BADS, Behavioral Activation for Depression Scale; EQ‐5D, EuroQol 5‐dimension questionnaire; FRHC, Fear of recurrence and serious health condition (structured questions); FSS, Fatigue Severity Scale; GAD‐7, Generalized Anxiety Disorder 7‐item scale; M.I.N.I., Mini‐International Neuropsychiatric Interview version 7.0.0; PCL‐5, Post‐traumatic Stress Disorder Checklist for DSM‐5; PCL‐C, adapted version of Post‐traumatic Stress Disorder Checklist‐Civilian version; PHQ‐9, Patient Health Questionnaire; PTSS, Post‐traumatic stress symptoms; SCS‐SF, Self‐Compassion Scale‐Short Form; TIC‐P, Treatment Inventory of Costs in Patients with psychiatric disorders.Eligible participants were enrolled and invited to an optional semi‐structured telephone interview with a licensed psychologist to explore concerns, needs, healthcare utilization, and productivity loss, alongside expectations on the trial and intervention. Participants gained access to the Portal assessment at baseline (Table | PMC10028033 |
Intervention | depression, anxiety disorder, EJDeR | The EJDeR protocol is published following the Template for Intervention Description and Replication (TIDieR) checklist.EJDeR is a guided internet‐administered LICBT intervention delivered over 12 weeks on the Portal and includes text, illustrations, film, audio files, in‐module exercises, and homework exercises. EJDeR includes two LICBT techniques: behavioral activation (BA) for depression, and worry management (WM) for generalized anxiety disorder (GAD).E‐therapist guidance is provided via an initial assessment session (video‐conferencing or telephone, ≈45 min); weekly support via written messages via the Portal (≈20–30 min/week), and a mid‐intervention booster session (video‐conferencing or telephone, ≈30–45 min) following structured protocols. | PMC10028033 |
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Outcomes | semi‐structured, suicidality, Semi‐structured, psychiatric disorders | Feasibility outcomes are informed by the CONSORT 2010 statement extension for randomized pilot and feasibility trials,Overview of feasibility outcomes, methods of evaluation, and progression criteriaPercentage completing assessmentsM.I.N.I. (eligibility interview, post‐treatment, and follow‐up)Semi‐structured interview (baseline and post‐treatment)Portal assessment (baseline, post‐treatment, and follow‐up)Weekly Portal assessmentNumbers of missing itemsM.I.N.I. (eligibility interview, post‐treatment, and follow‐up)Portal assessment (baseline, post‐treatment, and follow‐up)Weekly Portal assessmentRate of study dropoutRate of intervention dropout≤30%≤30%Length of time required for:Participants to work through the interventionParticipants to complete the initial assessment session and mid‐intervention booster session with e‐therapistParticipants to complete the eligibility interview, M.I.N.I., semi‐structured interview, Portal assessment at each time‐pointE‐therapists to deliver the interventionNumber of:Internal and external study personnelReminder contacts needed during recruitmentReminder contacts needed to complete Portal assessment at each time‐pointContacts needed to arrange eligibility interview, M.I.N.I. and semi‐structured interview over the telephone at each time‐pointNumber of:Participants adhering to the minimum treatment dose (MTD)Opened modulesCompleted LICBT modules started withCompleted initial assessment sessionsCompleted mid‐intervention booster sessionsCompleted homework sheetsNumber of:Participant loginsParticipant written messagesE‐therapist written messagesReasons for low adherence and dropout from study and interventionNumber of risk assessmentsImpressions and experiences of working with the intervention (including positive and negative consequences) and of completing assessments and interviewsNo criteria setNo criteria set<1 participant reporting substantial negative consequences related to participation in the study and/or interventionAbbreviations: LICBT, low intensity cognitive behavioral therapy; M.I.N.I., Mini‐International Neuropsychiatric Interview version 7.0.0.If one or more criteria are not met revisions should be considered before proceeding to a controlled trial.Outcome is to be reported in separate publications.The post‐treatment time‐point was set at 12 weeks, immediately after the EJDeR intervention had finished. A 6‐month follow‐up time‐point was selected to examine the feasibility of longer‐term data collection.Sociodemographic data on parents and children, specific modules of the M.I.N.I. assessing current and past psychiatric disorders and suicidality, and psychological and health economic measures are reported in Table Semi‐structured interviews were conducted at baseline and post‐treatment with licensed psychologists (data reported elsewhere). | PMC10028033 |
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Sample size | Following recommendations for feasibility trial sample sizes the target sample size was 50. | PMC10028033 |
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Double data entry | Paper‐based CRFs were used for data collected outside the Portal, with data independently entered onto a Microsoft® Access database by two research assistants, exported into Microsoft® Excel spreadsheets, with accuracy checked using Microsoft® Spreadsheet. | PMC10028033 |
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Reminders | A prompt (SMS and/or e‐mail) was sent when it was time to complete Portal assessments with automatic reminders (SMS and/or e‐mail) sent if not completed within 1 week. Participants who did not complete Portal assessments within 2 weeks, were offered to complete over the telephone, with up to six reminder attempts made via telephone, SMS, or email. Informed by evidence suggesting study newsletters can improve retention | PMC10028033 |
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Participant adherence | The minimum treatment dose (MTD) (i.e., full intervention adherence) was defined as: (1) attendance of the initial assessment session; (2) completion of the introduction and psychoeducation module; (3) completion of one LICBT module (BA or WM); and (4) attendance of the mid‐intervention booster session. | PMC10028033 |
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E‐therapist adherence | A 15% random sample of initial assessment and mid‐intervention booster sessions and written messages via the Portal from e‐therapists were marked for adherence, with each item within the structured support protocols marked as absent/present. | PMC10028033 |
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Statistical methods | RECRUITMENT | Feasibility outcomes relating to recruitment and eligibility, data collection, attrition, resources needed to complete the study and the intervention, participants' adherence to the intervention, participants' use of the intervention, e‐therapists' adherence to the intervention, and participants' sociodemographic characteristics are reported using descriptive statistics. Numbers and percentages (and 95% CIs where appropriate) are reported for categorical variables, means and SDs for continuous variables. Numbers and percentages of participants meeting criteria for each M.I.N.I. diagnosis is reported at each time‐point. Means and SDs for continuous variables and numbers and percentages for categorical variables are reported for all outcomes at each time‐point. Mean change scores (with 95% CIs) are reported for Portal assessments of psychological outcomes at each time‐point, to describe the study sample. | PMC10028033 |
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Risk and safety procedures | depression | Participants scoring >0 on PHQ‐9 (depression) question 9 (suicidal ideation), or a total score >20 (severe depression) were risk assessed by a licensed psychologist within one working day. If needed, participants were directed to appropriate support and excluded. | PMC10028033 |
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Public involvement | cancer | CANCER | A Parent Research Partner (PRP) group was established consisting of four parents with lived experience of being a parent of a child treated for cancer (two fathers and two mothers, aged between 45 and 54 years of age). The PRP group was involved in optimizing the acceptability of EJDeR e.g., relevancy, ease of understanding, content, language, and structure. | PMC10028033 |
RESULTS | RECRUITMENT | Data supporting feasibility objectives pertaining to recruitment and eligibility, data collection, attrition, and resources needed to complete the study and intervention are available in Zenodo. | PMC10028033 |
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Recruitment and eligibility | PTSD | DISORDER, REMISSION | Participant flow is summarized in an adapted CONSORT diagram (Figure Study flow of participants in the ENGAGE feasibility trial. Solid black lines denote participant flow through the study, including study drop outs i.e., those who discontinued the study. Dashed gray lines represent participants that were lost to follow‐up during assessments at post‐treatment (12 weeks) and follow‐up (6 months) respectively, but had not dropped out of the study.Ambiguities regarding eligibility arose in six cases. In three cases, parents met criteria for PTSD according to the M.I.N.I. but were included as symptoms were mild. In one case a parent met criteria for Alcohol Use Disorder, and was included due to being in early remission. One was attending a psychological support group; study inclusion was delayed until the group ended. One reported their child had recently relapsed, however, as treatment had not started, the parent was included.Out of 509 parents identified via the CCR and NAVET, 164 (32.2%) opted out, and 137 provided a response to the multiple‐choice question regarding reasons for non‐participation. Not experiencing any need for psychological support (93/137, 67.9%) was most commonly reported (Table | PMC10028033 |
Sociodemographic and clinical characteristics | Baseline sociodemographic and clinical characteristics for participants (Baseline sociodemographic and clinical self‐report characteristics for participants (
Multiple responses possible.Participants' internet usage is reported in Table | PMC10028033 |
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Data collection | Data collection (baseline, post‐treatment, and follow‐up) took place between 24‐07‐2020 and 04‐10‐2021. Percentage completing assessments at each time‐point are reported in Table Number and percentages of participants completing assessments of the total study sample (Total sample defined as all participants enrolled into the ENGAGE feasibility trial.Study sample at time‐point defined as the total number of participants remaining in the ENGAGE feasibility trial (i.e., had not dropped out of, or been excluded from, the study at each time‐point).Missing data ranged from 0.01%–4.1% items missing per measure, bettering progression criteria (≤10%). Missing data from the M.I.N.I. is reported in Table | PMC10028033 |
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Attrition | In total, 18/75 (24.0% [95%CI, 14.9–35.3]) of participants enrolled into the study dropped out of the study, bettering progression criteria (≤30%). In total, 17/72 (23.6% [95%CI, 14.4–35.1]) of participants gaining access to EJDeR, dropped out of EJDeR, bettering progression criteria (≤30%). | PMC10028033 |
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Resources needed to complete the study and the intervention | Length of time for participants to work through EJDeR and complete assessments at each time‐point are provided in Table Seventy‐two participants gained access to EJDeR and 71 were allocated to an e‐therapist (one dropped out before allocation). Psychology program students (Difficulties recruiting research personnel was identified as a challenge. | PMC10028033 |
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Participants' adherence to intervention | Seventy‐two participants gained access to EJDeR. One was excluded shortly after access (severe and enduring mental health difficulty) and 34/71 (47.9%) adhered to the MTD, nearly meeting progression criteria of 50%. The mean number of modules opened was 2.3 (SD 0.9, range, 1–4), parents completed a mean of 1.7 modules (SD 1.3, range, 0–4), and a mean of 2.7 homework sheets (SD 2.8, range, 0–11). Initial assessment sessions were attended by 61/71 (85.9%) and mid‐intervention booster sessions were attended by 44/71 (62.0%).Visual inspection of data indicated differences in adherence rates by first LICBT module started and by gender. A post hoc descriptive analysis was performed. In total, 54/71 (76.1%) started a LICBT module, with 26 starting with BA and 28 with WM. In total, 20/26 (76.9%) starting with BA, and 14/28 (50.0%) starting with WM adhered to the MTD.Of the 71 participants, 25 were fathers, and 46 were mothers. For fathers: 8/25 (32.0%) started with BA and 7/8 (87.5%) adhered to the MTD; 12/25 (48.0%) started with WM, and 5/12 (41.7%) adhered to the MTD. For mothers, 18/46 (39.1%) started working with BA and 13/18 (72.2%) adhered to the MTD; 16/46 (34.8%) started with WM and 9/16 (56.3%) adhered to the MTD. | PMC10028033 |
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Participants' use of the intervention | SD | A mean of 20 participant logins were made (SD 14.9, range, 1–72). A mean of 8.5 participant written messages were sent to e‐therapists (SD 7.6, range, 0–33), and a mean of 28.8 e‐therapist written messages (SD 16.3, range, 0–74) were sent to participants. | PMC10028033 |
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E‐therapists' adherence to intervention | Adherence rates were 90.5% for initial assessment sessions, 85.2% for mid‐intervention booster sessions, and 87.5% for written communication between participants and e‐therapists. | PMC10028033 |
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Participants' acceptability of the intervention and data collection | Reasons for study dropout are reported in Figure | PMC10028033 |
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Psychological and health economics outcomes | PTSS, Anxiety, Stress Disorder, Depression, Fatigue | DISORDER, RECURRENCE | M.I.N.I. data at baseline, post‐treatment, and follow‐up are provided in Table Treatment outcomes at baseline, post‐treatment, and follow‐up with change scoresAbbreviations: AAQ‐6, Acceptance and Action Questionnaire; BADS, Behavioral Activation for Depression Scale; EQ‐5D, EuroQol 5‐dimension questionnaire; EQ‐5D VAS, EuroQol 5‐dimension questionnaire visual analogue scale; FSS, Fatigue Severity Scale; FRHC, Fear of recurrence and serious health condition (structured questions); GAD‐7, Generalized Anxiety Disorder 7‐item scale; PCL‐5, Post‐traumatic Stress Disorder Checklist for DSM‐5; PCL‐C, adapted version of Post‐traumatic Stress Disorder Checklist‐Civilian version; PHQ‐9, Patient Health Questionnaire; PTSS, Post‐traumatic stress symptoms; SCS‐SF, Self‐Compassion Scale‐Short Form.95% CIs around SD. | PMC10028033 |
DISCUSSION | cancer, depression, depressive, anxiety | CANCER | The ENGAGE feasibility trial demonstrated it is possible to recruit and retain parents of children treated for cancer into a single‐arm feasibility trial of an internet administered, guided, LICBT based, self‐help intervention. In summary: (1) 12.0% of invited parents consented and 11.0% of invited parents were enrolled, exceeding progression criteria of ≥9%; (2) 24.0% dropped out of the study, and 23.6% dropped out of the intervention, bettering progression criteria of ≤30%; (3) missing items per questionnaire ranged from 0.01% to 3.9%, remaining under ≤10% for all measures, bettering progression criteria; (4) percentage of participants completing assessments ranged from 65.6% to 98.7%, bettering progression criteria of ≥70% for M.I.N.I interviews at all time‐points and Portal assessments at baseline, and marginally under progression criteria of ≥70% for Portal assessments at post‐treatment and follow‐up; (5) intervention adherence was 47.9%, marginally under progression criteria of ≥50%; and (6) no participant reported a substantial negative consequence related to the study and/or intervention, meeting progression criteria. This study was not designed to detect differences in parental depression or anxiety at follow‐up, however reductions in depressive and anxiety symptoms were observed via visual inspection. | PMC10028033 |
Strengths and limitations | cancer, TIDieR | CANCER | To the best of our knowledge, ENGAGE is first trial worldwide designed to test the feasibility of an internet administered, guided, LICBT based, self‐help intervention for parents of children treated for cancer. Robust methods examined a range of feasibility objectives, alongside a priori specified progression criteria. The intervention protocol is published in accordance with TIDieR guidelinesThe study also has limitations. E‐therapists adherence to the intervention was examined by only one licensed clinical psychologist with adherence marked as absent/present. Future studies should develop an intervention adherence checking tool, examining both adherence and quality. | PMC10028033 |
Interpretation and implications for future research | cancer | CANCER, RECRUITMENT | While we successfully recruited our target sample size with an enrolment rate of 11.0%, confidence intervals ranged from 8.4% to 14.1% and in a future pilot RCT we will continue to identify participants via additional sources such as cancer organizations and interest groups. Further, we targeted parents of children treated for cancer with a self‐reported need for psychological support. Lack of recognition of one's psychological difficulties and lack of acknowledgement for the need of support, are commonly identified barriers to seeking help.Our study dropout rate of 24.0% bettered progression criteria of ≤30%. Confidence intervals ranged from 14.9% to 35.3% and we aim to minimize study dropout in the forthcoming future pilot RCT by continuing to use retention strategies, including telephone remindersOur intervention adherence rate of 47.9% was slightly lower than progression criteria (≥50%) and there was no evidence of harm. Results suggest the intervention may be feasible and acceptable for the population and are in line with other research suggesting internet‐administered delivery mechanisms are acceptable to parents of children on cancer treatmentRecruitment of experienced research personnel was challengingPsychology program student e‐therapists did not have time to support caseloads and more experienced licensed psychologists and a CBT‐therapist supported the majority of participants. Further, psychology program student e‐therapists spent a mean time of 2.9 h per participant, per week, which is more therapist time than reported in other studies on guided internet‐administered CBT interventions.In summary, the following modifications to the study protocol and EJDeR are warranted before commencing a pilot RCT: (1) collection of outcome assessment data via telephone; (2) reducing the number of measures; (3) adaptation of the intervention to improve the feasibility and acceptability of EJDeR; (4) recruitment of a trial coordinator; (5) recruitment of part‐time employed e‐therapists to increase caseloads and decrease time spent on each participant; (6) use of electronic CRFs to facilitate data collection and entry; and (7) training of research team members to collect research data over the telephone. | PMC10028033 |
CONCLUSIONS | RECRUITMENT | Using robust methods, including a priori specified progression criteria, the use of novel recruitment strategies | PMC10028033 |
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AUTHOR CONTRIBUTIONS | PMC10028033 |
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FUNDING INFORMATION | Cancer | CHILDHOOD CANCER, CANCER | This work is supported by the Swedish Research Council (grant number 521‐2014‐3337/E0333701, 2018‐02578, and 2021‐00868), the Swedish Cancer Society (grant number 15 0673 and 17 0709), the Swedish Childhood Cancer Foundation (grant number PR2017‐0005), and funding via the Swedish Research Council to U‐CARE, a Strategic Research environment (Dnr 2009‐1093). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. | PMC10028033 |
CONFLICTS OF INTEREST | Declaration of interest: none. | PMC10028033 |
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ETHICS APPROVAL STATEMENT | The ENGAGE feasibility trial was approved by the Regional Ethical Review Board in Uppsala, Sweden (Dnr: 2017/527) and was conducted in accordance with the Helsinki Declaration, ensuring the welfare and rights of all participants, and Good Clinical Practice (GCP) guidelines. Ethical amendment was obtained from Swedish Ethical Review Authority August 07, 2019, ref: 2019‐03083. | PMC10028033 |
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PATIENT CONSENT STATEMENT | Not applicable. | PMC10028033 |
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PERMISSION TO REPRODUCE MATERIAL FROM OTHER SOURCES | Not applicable. | PMC10028033 |
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TRIAL REGISTRATION | ISRCTN 57233429. | PMC10028033 |
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Supporting information |
Data S1
Click here for additional data file. | PMC10028033 |
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ACKNOWLEDGMENTS | We wish to thank Ian Horne (Portal team member) for performing all data extractions on the Portal. We thank data coordinator Agnes von Essen for assistance with data entry, data processing, and data organization. We also thank the e‐therapists and clinical psychologists who facilitated intervention delivery and data collection. The authors are also thankful to Professor Paul Farrand for sharing his expertise and time to work with the research team to develop the EJDeR intervention. Finally, we are especially grateful to the four members of our Parent Research Partner Group. | PMC10028033 |
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DATA AVAILABILITY STATEMENT | RECRUITMENT | Data supporting feasibility objectives pertaining to recruitment and eligibility, data collection, attrition, and resources needed to complete the study and intervention are available in Zenodo at | PMC10028033 |
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REFERENCES | PMC10028033 |
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Abstract | Ruilin Meng and Haofeng Xu are joint first authors. | PMC10076092 |
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Background | Drowning, death | Drowning is the leading cause of death for children under the age of 15 years in Guangdong Province, China. This serious public health issue also exists in low- and middle-income countries (LMICs), which have few value-integrated intervention programs. The current study presents an integrated intervention project that aims to explore an effective pattern of prevention for child drowning in rural areas and feasibility to perform in other LMICs. | PMC10076092 |
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Methods | We conducted a cluster randomized controlled trial by comparing the incidence of non-fatal drowning among children in two groups in rural areas of southern China. We recruited the participants in two phases and reached a total of 10 687 students from 23 schools at two towns in Guangdong Province, China. At the first and second phases, 8966 and 1721 students were recruited, respectively. | PMC10076092 |
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Results | The final evaluation questionnaires were collected after 18 months of integrated intervention, where we obtained 9791 data from Grades 3–9. The incidence of non-fatal drowning between the intervention and control groups after intervention did not differ significantly from the baseline according to the total number of students, male students, female students and Grades 6–9 [0.81; 95% confidence interval (CI): [0.66, 1.00]; | PMC10076092 |
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Conclusions | The integrated intervention exerted a significant impact on the prevention and management of child non-fatal drowning, especially in rural areas. | PMC10076092 |
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INTRODUCTION | death | DISEASE | The disease burden of child drowning remains at a high level, such that it is among the top 10 leading causes of death among children and young people worldwide [The rates of child drowning exhibited a continuing decline in high-income countries (HICs). Prevention strategies in view of the peculiar characteristics of child drowning included promoting multisectoral collaboration, strengthening public awareness of drowning through communication, establishing a national water safety plan and conducting research on the prevention of drowning in HICs [In low- and middle-income countries (LMICs), different prevention strategies may be required according to area due to the significant variation in the characteristics of drowning. Many integral health promotion programs were developed with specific objectives, which included improving health care, developing health behaviours and monitoring the number of accidents. Scholars suggested educating guardians to master supervision skills as a key measure in the prevention of child injury [In China, drowning is the leading cause of death in children aged 1–14 years [In China, three health education programs on the prevention of child drowning for children or parents were implemented in rural areas in Guangdong, Jiangsu, Zhejiang Province, which reduced morbidity/mortality related to drowning in childhood [Intervention strategies, such as enhancing the quality of caregivers through education, which were effective in other countries, may not be feasible in rural areas in China due to regional differences [The study, which used a repeated-measure intervention-control design, conducted a 3-year program to provide intervention to prevent drowning for rural students. The integrated intervention project aimed to explore an effective pattern of prevention for child drowning in rural areas and to examine the feasibility of implementing the program to other LMICs. | PMC10076092 |
METHODS | Based on the mortality surveillance data for Guangdong Province, we conducted a study in two rural townships in Qingyuan City, namely, Jintan and Longjing, which feature abundant nature and man-made bodies of water and high mortality rates due to drowning. We used the cluster random sampling strategy to assign the two townships into intervention (Jintan) and control (Longjing) groups through simple randomization (i.e. a coin toss). The study recruited students from 23 schools (18 elementary schools and 5 middle schools) in the two towns. The students were cluster randomized into the intervention or control group. The target populations were all students in Grades 3–8 (8–18 years old) at baseline and Grades 3–9 at the final evaluation (18 months after the intervention). | PMC10076092 |
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Participant and public involvement | DISEASE | The development of the research questionnaire and outcome measures was informed by a study by Ma, The study recruited 8966 and 1721 students for two phases, respectively, for a total of 10 687. At the second phase of the study, 896 (544 and 352 students from the intervention and control groups, respectively) were excluded after graduation (in China, students in elementary, middle and high schools generally do not change schools except after graduation). Informed consent was obtained from all subjects (parents or legal guardians provided consent for subjects aged less than 18 years).The intervention group received the integrated intervention, and the control group received general health education prior to the final evaluation. At the start of the program, we collected 8390 responses to the self-reported questionnaire out of 8966 students in Grades 3–8 in the two towns. Out of the 8390 responses, 73 were excluded due to missing information. Prior to the end of the program, the study collected a total of 9791 responses from students in Grades 3–9 for both groups for the final evaluation survey. Out of 9791 responses, the study further excluded 34 due to missing information (Basic characteristics of the two townsInstitutions involved in the study will also help with the dissemination of the findings: we intend to demonstrate the results to local authorities to enforce the incorporation of the intervention in the future and engage the development of drowning policies.Institutions did not assess the burden of the intervention, because the project was funded by the National Centre for Chronic Non-Communicable Disease Control and Prevention, Health Commission of Guangdong Province. | PMC10076092 |
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Integrated intervention | DISEASE, CROSS | This program was implemented from July 2014 to December 2016. The intervention group received the integrated intervention, which included systematic health education, community actions, policies promotion strategies and environmental improvement (Components of integrated intervention and measurement timesFurthermore, all students and their families and teachers in the intervention group underwent health education. For students, the Guangdong Provincial Centre for Disease Control and Prevention and the Red Cross Society of Guangdong Province and its volunteers provided regular systematic health education (knowledge about drowning, prevention skills about water safety training, self-rescue skills, rescue skills through health manuals, bulletins and lectures). The guardians of students in the intervention group (including new students in Grade 3) received health manuals, bulletins and lessons in water safety, high-risk factors and supervision skills. Demonstrations of drowning prevention skills (self-rescue and rescue skills) were performed in all schools for the intervention group for the majority of teachers (class teachers, gym teachers and Principals of Security).Community actions were conducted by village committees, which organized villagers to establish river patrol parties and childcare teams to monitor the water and supervise students. The local government issued a document that outlined the responsibilities of relevant institutions in implementing environmental improvement and the rescue of drowning children. These strategies included surrounding the water with bamboo fences or barriers and building self-latching gates for houses.For the control group, general safety education manuals were distributed to the participants (including their guardians and teachers). After the project, the control group also received the same intervention for drowning prevention (Model for the implementation of the integrated intervention for the prevention of children drowning in Guangdong Province, China, using a cluster randomized controlled trial. | PMC10076092 |
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Data collection and analysis | death, respiratory impairment | RESPIRATORY IMPAIRMENT | The study conducted baseline and final evaluation surveys for both groups. The design of the questionnaire was based on a previous study conducted on child drowning prevention [The study used the same questionnaire with the same definition of drowning for both groups in a double-blind method by investigators. According to the World Health Organization, drowning is the process of experiencing respiratory impairment from submersion/immersion in liquid. The outcomes are classified as death, morbidity and no morbidity [The information in the questionnaireThe sample size was calculated based on the intracluster correlation coefficient (ICC: the ratio of between-cluster variance to between- and within-cluster variances), drowning incidence rate and the expected effect size. The rate of incident of non-fatal drowning among children was estimated at 10% for Grades 3–9 [The two townships were randomly assigned to the intervention and control groups. The study employed univariate analysis using The study analysed the differences in the incidence of drowning, knowledge and high-risk behaviours between the intervention and control groups at the end of project using the difference-in-differences (DID) method. Analyses were performed using SPSS V.21.0 and SAS version 9.2. | PMC10076092 |
RESULTS | The study obtained a total of 8317 questionnaires from students in Grades 3–8 at baseline; the average ages [standard deviation (SD)] were 12.5 (1.9; Baseline characteristics of students in the two groupsFor the final evaluation survey, the study obtained a total of 9757 responses from students in Grades 3–9 (control group: 3663; intervention group: 6094). The average ages (SD) of intervention and control groups were 12.2 (1.9) and 12.2 (2.0) years, respectively. The study observed no difference in the basic demographic characteristics between the two groups ( | PMC10076092 |
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Incidence of non-fatal drowning | At baseline, the intervention group displayed a higher incidence rate for non-fatal drowning in terms of the total number of students, male students, female students and Grades 3–5 than that of the control group (
The primary outcome at 18-month follow-up of the integrated intervention | PMC10076092 |
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Changes in awareness and risk behaviours related to non-fatal drowning | By the end of the study, awareness and risk behaviours displayed positive benefits (0.27; 95% CI: [0.21, 0.33]; | PMC10076092 |
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DISCUSSION | death, drowning | EVENTS, DISEASE | In China, drowning mortality in 2017 was higher than the global average despite the substantial decline in the disease burden of drowning from 1990 to 2015 [Analysis suggested that integrated intervention could reduce the incidence of non-fatal drowning among younger students. Alternatively, the results implied significant positive changes in knowledge and behaviour according to the total number of students in the intervention group. The risk factors reported by other studies [According to a review, the current study obtained results similar to those of other drowning prevention studies in HICs, which were found to be effective only on intermediary outcomes (increased levels of drowning skills and knowledge). However, the study was unable to find any impact of the reduction of the number of drowning events among the target population [The risk factors for child drowning in rural areas included open water, low levels of knowledge and skills and unsupervised of children access to water. Hence, the important topics of drowning prevention studies are improving the home environment and natural bodies of water and the development of knowledge and skills against drowning among the target population [Among childhood injury events, drowning ranked first as the cause of death in Guangdong Province, China [This study has its limitations. First, data were based on self-reports, which may induce recall bias. Second, the results were impacted when the control group was exposed to the community education for child safety. | PMC10076092 |
CONCLUSION | The program of the integrated intervention for drowning prevention of non-fatal drowning among younger students has increased awareness and reduced risk behaviours associated with child drowning. The study explored an effective pattern for the integrated prevention of child drowning in LMICs. | PMC10076092 |
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ACKNOWLEDGEMENTS | NON-COMMUNICABLE DISEASE, DISEASE | The project was conducted under the support of the National Centre for Non-communicable Disease Control and Prevention, Qingyuan City Centre for Disease Control and Prevention and Qingxin District Centre for Disease Control and Prevention. The authors would like to acknowledge their field work and contribution. | PMC10076092 |
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AUTHOR CONTRIBUTIONS | Ruilin Meng (Data curation [lead], Investigation [lead], Project administration [lead], Software [equal], Writing—original draft [lead]), Haofeng Xu (Data curation [supporting], Investigation [lead], Project administration [lead]), Mingqu Zhang (Data curation [supporting], Investigation [supporting], Project administration [supporting]), Pengpeng Ye (Software [equal]), Zhishan Zhou (Data curation [supporting], Investigation [supporting], Project administration [supporting]), Xuhao Zhu (Data curation [supporting], Investigation [supporting], Project administration [supporting]), Xingru Li (Data curation [supporting], Investigation [supporting], Project administration [supporting]), and Lifeng Lin (Data curation [supporting], Investigation [supporting], Project administration [lead], Writing—review & editing [lead]) | PMC10076092 |
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ETHICS APPROVAL AND CONSENT TO PARTICIPATE | The study was approved by Ethical Review Committee of NCNCD, China CDC. The study is no ethics committee approval ID. Informed consent was obtained from all subjects, if subjects were under 16, from a parent or legal guardian. All methods were carried out in accordance with relevant guidelines and regulation. | PMC10076092 |
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FUNDING | NON-COMMUNICABLE DISEASE | This project was funded by the National Centre for Chronic Non-communicable Disease Control and Prevention and Health Commission of Guangdong Province. There is no award/grant number for this project. | PMC10076092 |
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DATA AVAILABILITY | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10076092 |
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