## Protocol Section
### Identification Module
**NCT ID:** NCT06431321

**Brief Title:** Evaluation of a 2-session Parent Training Programme for Caregivers of Younger Children in Zimbabwe

**Official Title:** A Pilot Cluster Randomised Controlled Trial of a Two-session Parent Training Programme for Delivery to Caregivers of Children Enrolled in Early Childhood Development in Harare, Zimbabwe

#### Organization Study ID Info
**ID:** WNDNOR001
#### Organization
**Class:** OTHER
**Full Name:** University of Cape Town
### Status Module
#### Completion Date
**Date:** 2024-09-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Parenting for Lifelong Health

**Class:** UNKNOWN

**Name:** Mikhulu Trust

**Class:** UNKNOWN

**Name:** Clowns Without Borders South Africa

**Class:** UNKNOWN

**Name:** Ministry of Primary and Secondary Education Zimbabwe

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Cape Town

#### Responsible Party

**Investigator Affiliation:** University of Cape Town

**Investigator Full Name:** Noreen Wini Dari

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** A pilot, exploratory cluster Randomised Controlled Trial (RCT) with two arms will be conducted to test a two-session parent training programme for caregivers of children enrolled in early childhood development classes in Harare Zimbabwe. The Parenting for Lifelong Health programme for Young Children together with the Mikhulu Trust Book Sharing Programme for Young Children will be adapted into a two-session version programme named Tabudirira Parent Training Intervention for Early Childhood Development.

The RCT aims to assess the following objectives:

Can the programme reduce child maltreatment? Does the intervention improve parent-child engagement with reading material? How best can the 2-session programme delivery be optimised?

**Detailed Description:** A pilot, exploratory cluster Randomised Controlled Trial (RCT) with two arms will be conducted to test a two-session parent training programme for caregivers of children enrolled in early childhood development classes in Harare, Zimbabwe. The Parenting for Lifelong Health programme for Young Children together with the Mikhulu Trust Book Sharing Programme for Young Children will be adapted into a two-session version programme named Tabudirira Parent Training Intervention for Early Childhood Development.

The RCT aims to assess the following objectives:

Can the programme reduce child maltreatment? Does the intervention improve parent-child engagement with reading material? How best can the 2-session programme delivery be optimised?

The RCt will have 2 arms with 120 caregivers /arms. The intervention will be a 2-session parent training programme while the control is a 2-session nutrition knowledge dissemination workshop delivered over 2 sessions.

### Conditions Module

**Conditions:**

- Child Maltreatment

**Keywords:**

- Child Maltreatment

- Parenting

- Violence Against Children (VAC)

- Prevention

- Parenting Intervention

- Early Childhood Development (ECD)

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Each study arm will have 8 schools Schools will be randomly assigned to the study arm

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Research assistants and the statistician will be blinded until the analyses are completed. The randomisation process is concealed from research assistants in order to avoid experimenter bias. Complete statistical analysis plans will be prepared before the data is locked, and analysis tactics are predetermined. Until the data are finalised, the study statistician will not be aware of the treatment assignment

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 240

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The Tabudirira Parenting Intervention for Early Childhood Development will be delivered to parents of children aged 4-5 years in Harare, Zimbabwe. Trained facilitators will deliver the programme face to face, and a group of 15 parents will have 3 facilitators. The facilitators comprise of teachers working as guidance and counselling coordinators and psychology graduates. The programme consists of 2 sessions that will be delivered once a week over 2 weeks, with each session lasting 2.5 to 3 hours. The session will have various activities which focus on learning from each other and practising positive parenting behaviours. At the end of each session, parents will receive a home activity which allows them to practise the content taught during the session. At the end of session 2 parents will receive a parent handbook with the summary of the 2 sessions. Schools will be used as venues and the facilitators will receive ongoing mentoring and coaching during programme delivery.

**Intervention Names:**

- Behavioral: Tabudira Parenting Intervention for Early Childhood Development

**Label:** Parent training intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The control group (8 groups with 15 parents each) will receive a one-hour session on nutrition with facilitators trained by a nutritionist focusing on children aged 4-7 years. The parents will also receive a nutrition handbook. Zimbabwe is faced with the triple burden of malnutrition: underweight, micronutrient deficiencies and overweight. There is an ongoing need to protect and promote diets, services and practices through a multi-systems approach that supports optimal nutrition, growth, and development for all children, using a parent support group can help achieve the goal. The nutrition programme has no components of positive parenting or links to the reduction of violence against children but will serve as a placebo control for the attention received by parents.

**Intervention Names:**

- Other: Nutritional guide for younger children

**Label:** Control

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Parent training intervention

**Description:** 2 session programme delivered weekly over 2 weeks using group-based delivery aimed at reducing child maltreatment, improving parenting behaviours and parent's mental health.

**Name:** Tabudira Parenting Intervention for Early Childhood Development

**Other Names:**

- Parenting for Lifelong Health Young Children combined with Mikhulu Trust Book Sharing Programme - 2-Session Version

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Control

**Description:** 2 session programme delivered weekly over 2 weeks aimed at providing parents with nutritional education to help provide maximum nutrition to the growing child

**Name:** Nutritional guide for younger children

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** Barriers and enablers to delivery Barriers and enablers to parent engagement (attendance, homework completion)

**Measure:** Implementation Outcomes

**Time Frame:** 6 weeks

#### Primary Outcomes

**Description:** The International Child Abuse Screening Tool-Trial version (ICAST-T) measures the occurrence of respondents' discipline behaviour towards the child

**Measure:** Changes in frequency of child maltreatment:

**Time Frame:** 6 weeks

#### Secondary Outcomes

**Description:** Changes in attitudes towards harsh parenting will be measured using two items from the ICAST-T measure used in measuring the primary outcome. The questions will seek to understand parental attitudes towards harsh discipline for example: In the past 6 weeks, how often did physical discipline seem like the only option for stopping bad behaviour?

**Measure:** Changes in attitudes towards harsh parenting

**Time Frame:** 6 weeks

**Description:** will be measured using 1 item from the ICAST-T the question: In the past 6 weeks, how often did you not know what to do when your child misbehaved

**Measure:** Changes in not knowing what to do when a child misbehaves

**Time Frame:** 6 weeks

**Description:** The Parenting Young Children Questionnaire (PARYC) has 9 items that contain statements of parenting behaviours that caregivers rate on a Likert scale from 1 (not at all) to 7 (most of the time). Two dimensions of the PARYC will be measured: Supporting Good Behaviour (e.g., "Notice/Praise good behaviour") and Setting Limits (e.g., "Stick to your rules"). The items included in the current questionnaire (Cronbach alpha 0.86). are informed by the metric invariance analysis of the measure done in a preceding study, pending publication. The preceding study measured the prevalence of violence against children and its correlates. The highest possible score is 63 indicating more parent-child engagement compared to the lowest possible score of 9 indicating fewer parent-child engagements.

**Measure:** Spending time with child, praising, naming emotions

**Time Frame:** 6 weeks

**Description:** Two items, similar in structure to those in the PARYC, will be used to assess this e.g. How often do you spend time book sharing with your child?

**Measure:** Changes in time spent engaging the child in book sharing

**Time Frame:** 6 weeks

**Description:** The Shona Symptoms Questionnaire (SSQ-14) will be used to assess parental mental health before and after the programme. The SSQ is a 14-item screening tool for common mental disorders and has a reliable internal consistency (0.85). It asks about symptoms such as thinking too much, failing to concentrate, work lagging, insomnia, suicidal ideation, unhappiness and so on, over 1 week. Highest total possible score of 14 indicates floundering parental mental health while a score of 0 indicates flourishing parental mental health

**Measure:** Changes in caregiver mental health

**Time Frame:** 6 weeks

**Description:** The Multidimensional Measure of Work-Family Conflict (MMWFC) measures work-family conflict on three constructs: time, strain and behaviour. The scale has 12 items, with responses on a 7-point Likert scale ranging from strongly disagree to strongly agree. The following are examples of items in the questionnaire: my work keeps me from my family activities more than I would like, I am often stressed from my family responsibilities, and I have a hard time concentrating on my work. The internal reliability was 0.92 in phase 1. The highest possible score is 84 indicating increased work-family conflict compared to 12 which is the lowest possible score indicating better work-family balance.

**Measure:** Changes in work-family conflict

**Time Frame:** 6 weeks

**Description:** : Four questions will be adapted from the Food and Agriculture Organisation of the United Nations guidelines for assessing nutrition-related knowledge, attitudes, and practices. The questions will assess the practices of the child's intake of healthy (2 items) and unhealthy snacks (2 items): How many times a day does your child eat candy? The items will be measured on a 6-point Likert scale ranging from Never to 6 times a day. The healthy eating scores will be reverse scored. The highest possible total is 24 indicating poor snacking practices compared to the lowest possible score of 4 for healthy snacking practices.

**Measure:** Changes in Knowledge of Child nutrition

**Time Frame:** 6 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Aged 18 years and above.
* Be a caregiver to a child enrolled in Early Childhood Development Grade A at a school in Harare Northern Central School district.
* Live with the child for a minimum of 5 days/ week.
* Provide informed consent before any study proceedings.

Exclusion Criteria

* Aged below 18
* A child enrolled in a school outside Harare Northern Central School District
* Child not enrolled in Early Childhood Development Grade A

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wndnor001@myuct.ac.za

**Name:** Noreen Wini Dari, MSc

**Phone:** +263 718 886340

**Role:** CONTACT

**Contact 2:**

**Email:** Catherine.Ward@uct.ac.za

**Name:** Cathrine Ward, PhD

**Phone:** +27 21 650 3422

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Harare

**Contacts:**

***Contact 1:***

- **Email:** mmazingi@ymail.com

- **Name:** Marian Mazingi District Official: Ministry of Primary and secondary Education

- **Phone:** +263 772 864 277

- **Role:** CONTACT

**Country:** Zimbabwe

**Facility:** Harare Northen Central School District

#### Overall Officials

**Official 1:**

**Affiliation:** University of Capetown

**Name:** Noreen Wini Dari, MSc

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Open

**Description:** Ziva Hub Anonymised Individual Participant Data

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** 2026

**URL:** https://zivahub.uct.ac.za/

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
