Engaging Together for Healthy Relationships

NCT05880979 | Completed

• 1 other identifier: STUDY22060047
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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.

Conditions

Violence in Adolescence; Domestic Violence

Outcome Measures

Primary Outcomes (8)

• Percentage of participants who are eligible out of the total who are approached

  Will assess through tracking data

  Through completion of study recruitment, an average of 6 months

• Percentage of participants who are consented out of the total who are eligible

  Will assess through tracking data

  Through completion of study recruitment, an average of 6 months

• Percentage of participants who complete the baseline survey out of the total who consented

  Will assess through tracking data

  Through completion of completing baseline surveys, an average of 6 months

• Percentage of participants who complete the well-visit out of the total who consented

  Will assess through tracking data

  Through completion of completing well-visits, an average of 6 months

• Percentage of participants who complete the immediate post-intervention survey out of the total who consented

  Will assess through tracking data

  Through completion of completing post-intervention survey, an average of 7 months

• Percentage of participants who complete the 1-month post-intervention survey out of the total who consented

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

  4 months

• Percentage of participants who complete the 3-month post-intervention survey out of the total who consented

  Will assess through tracking data

  Through completion of completing 3 month post-intervention survey, an average of 12 months

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

  Validated measure (Acceptability of Intervention Measure)

  Through completion of completing immediate post-visit surveys, an average of 6 months

Secondary Outcomes (6)

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

  Baseline, 3-month post intervention

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

  Baseline, 1 month post intervention, 3 month post-intervention

• Attitudes about ARA, change in outcome between baseline and 3 months

  Baseline, 3-month post intervention

• Parent-adolescent communication around dating and ARA, change in outcome over time

  Baseline, 3-month post intervention

• Parental monitoring around dating and ARA, change in outcome over time

  Baseline, 3-month post intervention

Study Arms (2)

Intervention (Engaging Together for Healthy Relationships)

EXPERIMENTAL

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.

Behavioral: Engaging Together for Healthy Relationships

Control (Receipt of regular well-child care)

ACTIVE COMPARATOR

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

Behavioral: Regular well child care

Interventions

Engaging Together for Healthy Relationships BEHAVIORAL

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

Intervention (Engaging Together for Healthy Relationships)

Regular well child care BEHAVIORAL

Participants will receive their regularly scheduled well-child care

Control (Receipt of regular well-child care)

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Providers:
• Sees patient at an eligible primary care clinic
• Speaks and understands English
• Age 18 or older
• Identifies as a pediatrician, nurse practitioner, physician assistant (pediatric primary care healthcare provider)
• Adolescents
• Age 11 to 15
• Attending an upcoming well-child visit from a provider enrolled in the study
• Caregiver who is accompanying well-child visit with adolescent is also participating
• Speaks and understands English
• Parents
• Is parent or primary caregiver for an adolescent age 11 to 15
• Adolescent has an upcoming well-child visit with a provider enrolled in the study
• Accompanying child to the well-visit
• Adolescent is interested and eligible to participate in study

You may not qualify if:

• Providers

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (2)

CCP South Hills

Monongahela, Pennsylvania, 15063, United States

Location

Primary Care Center Oakland

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: Randomization will occur at the provider-level

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 30, 2023
• Study Start: July 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

US (2)