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

NCT ID: NCT07039253

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-15

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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ETHR V 2.0 pilot trial is a one-arm (intervention only) pilot trial of Engaging Together for Healthy Relationships, a caregiver-adolescent dating violence prevention program delivered within pediatric primary care. We completed one round of the pilot trial in two clinics in Pittsburgh and now are expanding the trial to include two sites with all providers in each site. ETHR includes clinician training, in-clinic resources, and after visit text messages and resources for families. This is an intervention only trial to assess acceptability, feasibility, and exploratory pre/post changes in outcomes.

Conditions

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Dating Violence Parent Primary Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

Engaging Together for Health Relationships

Intervention Type BEHAVIORAL

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

Interventions

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Engaging Together for Health Relationships

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 12 to 16
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 12 to 16
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

* Unable to assent/consent
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Maya Ragavan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maya Ragavan, MD, MPH, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC Children's Community Practice

Monongahela, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erin Mickievicz, BA

Role: CONTACT

14126926000

Maya Ragavan

Role: CONTACT

4126926000

Facility Contacts

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Patrick Tate, MD

Role: primary

+1 412-882-7747

Erin Mickievicz, BA

Role: backup

4126926000

Other Identifiers

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1R21HD109627-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY25030017

Identifier Type: -

Identifier Source: org_study_id

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