Engaging Together for Healthy Relationships

NCT ID: NCT05880979

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-12-01

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

Violence in Adolescence; Domestic Violence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention (Engaging Together for Healthy Relationships)

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.

Group Type: EXPERIMENTAL

Engaging Together for Healthy Relationships

Intervention Type: BEHAVIORAL

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

Control (Receipt of regular well-child care)

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

Group Type: ACTIVE_COMPARATOR

Regular well child care

Intervention Type: BEHAVIORAL

Participants will receive their regularly scheduled well-child care

Interventions

Engaging Together for Healthy Relationships

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

Intervention Type: BEHAVIORAL

Regular well child care

Participants will receive their regularly scheduled well-child care

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Maya Ragavan

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CCP South Hills

Monongahela, Pennsylvania, United States

Primary Care Center Oakland

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY22060047

Identifier Type: -

Identifier Source: org_study_id