## Protocol Section
### Identification Module
**NCT ID:** NCT05880979

**Acronym:** ETHR

**Brief Title:** Engaging Together for Healthy Relationships

**Official Title:** Engaging Together for Healthy Relationships: A Pilot Trial to Test a Brief Dating Violence Prevention Intervention for Pediatric Primary Care

#### Organization Study ID Info
**ID:** STUDY22060047
#### Organization
**Class:** OTHER
**Full Name:** University of Pittsburgh
### Status Module
#### Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-23

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-07-01

**Type:** ACTUAL

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2023-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-12
**Study First Submit QC Date:** 2023-05-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Pittsburgh

#### Responsible Party

**Investigator Affiliation:** University of Pittsburgh

**Investigator Full Name:** Maya Ragavan

**Investigator Title:** Assistant Professor of Pediatrics

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this pilot randomized clinical trial is to assess feasibility and acceptability of a brief parent-adolescent dating violence prevention intervention (Engaging Together for Healthy Relationships; ETHR) delivered in pediatric primary care settings. The main questions it aims to answer is if ETHR is acceptable and feasible. 4 healthcare providers will receive ETHR to share with their patients which includes clinician training, provider-delivered scripts, resource guides, and a comprehensive website. This will be compared to providers conducting routine well-child care with their patients.

**Detailed Description:** The investigators are conducting a pilot randomized clinical trial to test a brief parent-adolescent dating violence prevention intervention (Engaging Together for Healthy Relationships; ETHR). ETHR has been developed for parents and adolescents, to be implemented within pediatric primary care settings. ETHR is a comprehensive intervention which includes a training for clinicians, brief educational scripts for providers, resource guides for the adolescent, parent, and dyad, a comprehensive website, and warm referral processes to connect families with local resources. The investigators will be comparing ETHR with routine care. The specific goal of the pilot trial is to test trial feasibility, as well as intervention acceptability and fidelity. The investigators also will be examining exploratory changes in secondary outcomes and early implementation barriers and facilitators.

Four pediatric clinics will participate in this study. The investigator will recruit two providers from each clinic and randomize them into the intervention provider or control provider. The intervention provider will receive ETHR and the control provider will complete their regular well-child care. The investigators will enroll 15 families in the intervention arm and 5 in the control arm (3:1 enrollment). Families who are seeing the intervention provider for a well-child visit will be enrolled in the intervention arm; those seeing the control provider will be enrolled in the control arm. Families will be eligible if they are seeing the intervention or control providers for a well child visit, if the adolescent coming for the well-visit is between 11 to 15, if both the caregiver and adolescent are interested in participating, and if the family speaks and understands English. Families will be called 2 weeks ahead of their visit to enroll, consent, and complete a baseline survey (both the adolescent and parent will complete the survey). Participants will then attend their well -visit (where they will receive ETHR or routine care, depending on their provider). They will complete an acceptability and fidelity survey immediately post-visit, a resource utilization survey 1 month post visit, and a follow up survey (identical to the baseline survey) 3 months post visit. Providers will complete a brief fidelity and acceptability survey after each study visit (15 for intervention providers, 5 for control providers). All providers and a subset of families enrolled in the intervention arm (20 dyads, 40 participants) will also complete post-intervention interviews.

### Conditions Module

**Conditions:**

- Violence in Adolescence

- Domestic Violence

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomization will occur at the provider-level

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Participants will be told in the consent form that they may receive information about dating violence during their well-visit or they may not. They will not be specifically told if their provider is the intervention provider or control provider.

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 168

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Providers and families in the intervention arm will receive the ETHR program which includes a clinician training, provider scripts, resource guides, a comprehensive website, and warm referral processes.

**Intervention Names:**

- Behavioral: Engaging Together for Healthy Relationships

**Label:** Intervention (Engaging Together for Healthy Relationships)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Providers and families in the control arm will receive regular well-child care. All providers in the control arm will have access to ETHR after the pilot trial is over

**Intervention Names:**

- Behavioral: Regular well child care

**Label:** Control (Receipt of regular well-child care)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention (Engaging Together for Healthy Relationships)

**Description:** A comprehensive parent-adolescent dating violence prevention intervention designed to be provider delivered within the context of a pediatric well-child visit

**Name:** Engaging Together for Healthy Relationships

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Control (Receipt of regular well-child care)

**Description:** Participants will receive their regularly scheduled well-child care

**Name:** Regular well child care

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Will assess through tracking data

**Measure:** Percentage of participants who are eligible out of the total who are approached

**Time Frame:** Through completion of study recruitment, an average of 6 months

**Description:** Will assess through tracking data

**Measure:** Percentage of participants who are consented out of the total who are eligible

**Time Frame:** Through completion of study recruitment, an average of 6 months

**Description:** Will assess through tracking data

**Measure:** Percentage of participants who complete the baseline survey out of the total who consented

**Time Frame:** Through completion of completing baseline surveys, an average of 6 months

**Description:** Will assess through tracking data

**Measure:** Percentage of participants who complete the well-visit out of the total who consented

**Time Frame:** Through completion of completing well-visits, an average of 6 months

**Description:** Will assess through tracking data

**Measure:** Percentage of participants who complete the immediate post-intervention survey out of the total who consented

**Time Frame:** Through completion of completing post-intervention survey, an average of 7 months

**Description:** Through completion of completing 1- month post-intervention survey, an average of 8 months

**Measure:** Percentage of participants who complete the 1-month post-intervention survey out of the total who consented

**Time Frame:** 4 months

**Description:** Will assess through tracking data

**Measure:** Percentage of participants who complete the 3-month post-intervention survey out of the total who consented

**Time Frame:** Through completion of completing 3 month post-intervention survey, an average of 12 months

**Description:** Validated measure (Acceptability of Intervention Measure)

**Measure:** Percentage of participants who strongly agree or agree that the intervention is acceptable using a 4-item validated measure (Acceptability of Intervention Measure)

**Time Frame:** Through completion of completing immediate post-visit surveys, an average of 6 months

#### Secondary Outcomes

**Description:** Self-efficacy around ARA prevention, 1-5 scale (5=higher self-efficacy)

**Measure:** Self-efficacy in preventing adolescent relationship abuse (ARA), change in outcome between baseline and 3 months

**Time Frame:** Baseline, 3-month post intervention

**Description:** Investigator developed measure (yes/no)

**Measure:** Percentage of participants who utilize ARA resources at each measurement point, change in outcome over time

**Time Frame:** Baseline, 1 month post intervention, 3 month post-intervention

**Description:** Attitudes about Abusive Relationships, 1-5 scale (1=not abusive, 5=very abusive)

**Measure:** Attitudes about ARA, change in outcome between baseline and 3 months

**Time Frame:** Baseline, 3-month post intervention

**Description:** Investigator developed measure, yes/no answer choices (yes=has communicated, no=has not communicated)

**Measure:** Parent-adolescent communication around dating and ARA, change in outcome over time

**Time Frame:** Baseline, 3-month post intervention

**Description:** Parenting Practices Scale (never to always; 1=never, 5=always)

**Measure:** Parental monitoring around dating and ARA, change in outcome over time

**Time Frame:** Baseline, 3-month post intervention

**Description:** CADRI Short Form 1-5 scale (never to everyday)

**Measure:** Percentage of adolescents reporting ARA victimization and perpetration

**Time Frame:** Baseline, 3-month post intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Providers:

1. Sees patient at an eligible primary care clinic
2. Speaks and understands English
3. Age 18 or older
4. Identifies as a pediatrician, nurse practitioner, physician assistant (pediatric primary care healthcare provider)

Adolescents

1. Age 11 to 15
2. Attending an upcoming well-child visit from a provider enrolled in the study
3. Caregiver who is accompanying well-child visit with adolescent is also participating
4. Speaks and understands English

Parents

1. Is parent or primary caregiver for an adolescent age 11 to 15
2. Adolescent has an upcoming well-child visit with a provider enrolled in the study
3. Accompanying child to the well-visit
4. Adolescent is interested and eligible to participate in study
5. Speaks and understand English

Exclusion Criteria:

Providers

1) Does not need inclusion criteria

**Healthy Volunteers:** True

**Minimum Age:** 11 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Monongahela

**Contacts:**

***Contact 1:***

- **Email:** ragavanm@chp.edu

- **Name:** Maya Ragavan

- **Phone:** 412-692-6545

- **Role:** CONTACT

***Contact 2:***

- **Email:** mickieviczee@upmc.edu

- **Name:** Erin Mickievicz

- **Role:** CONTACT

**Country:** United States

**Facility:** CCP South Hills

**State:** Pennsylvania

**Status:** RECRUITING

**Zip:** 15063

**Location 2:**

**City:** Pittsburgh

**Contacts:**

***Contact 1:***

- **Email:** ragavanm@chp.edu

- **Name:** Maya Ragavan

- **Phone:** 412-692-6545

- **Role:** CONTACT

***Contact 2:***

- **Email:** mickieviczee@upmc.edu

- **Name:** Erin Mickievicz

- **Role:** CONTACT

**Country:** United States

**Facility:** Primary Care Center Oakland

**State:** Pennsylvania

**Status:** RECRUITING

**Zip:** 15213

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
