Pilot Trial of Clinic-based Dating Violence Prevention Program for Adolescents and Caregivers

NCT07039253 | Recruiting

• 2 other identifiers: STUDY250300171R21HD109627-01A1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

ETHR V 2.0 pilot trial is a one-arm, multi-site pilot trial to assess the acceptability and feasibility of Engaging Together for Healthy Relationships, a caregiver-adolescent dating violence prevention program delivered within pediatric primary care.

Conditions

Dating Violence; Parent; Primary Care

Keywords

dating violence prevention; parental monitoring and communication; pilot trial; middle school

Outcome Measures

Primary Outcomes (10)

• 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

• Percent of participants who received intervention during pediatric primary care visit

  Investigator-developed measure with questions about what components of the intervention were received during the well visit

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

• Participants use intervention resources after the visit

  Investigator-developed measure on use of intervention resources after the visit

  Through completion of intervention, on average 3 months post well visit

Secondary Outcomes (8)

• 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

• Motivation around preventing dating violence

  Baseline, 3-month post intervention

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

  Baseline, 3-month post intervention

Study Arms (1)

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 take home box for families, post-visit text messages, a comprehensive website, and warm referral processes.

Behavioral: Engaging Together for Health Relationships

Interventions

Engaging Together for Health Relationships BEHAVIORAL

Dating violence intervention for caregivers and adolescents to be delivered within pediatric primary care

Engaging Together for Healthy Relationships

Eligibility Criteria

• Age: 12 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 12 to 16
• 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 12 to 16
• 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:

• Unable to assent/consent

Sponsors & Collaborators

• University of Pittsburgh: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

UPMC Children's Community Practice

Monongahela, Pennsylvania, 15063, United States

RECRUITING

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Maya Ragavan, MD, MPH, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Mickievicz, BA

CONTACT

14126926000; mickieviczee@upmc.edu

Maya Ragavan

CONTACT

4126926000; ragavanm@chp.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)