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NCT Number: NCT07039253

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

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.

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Key information

Conditions

Dating Violence Behavior Communication Parent Primary Care

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • Speaks and understand English

Exclusion criteria

  • Unable to assent/consent
  • Does not meet inclusion criteria

Treatment and study plan

Engaging Together for Health Relationships

Behavioral

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

Primary outcomes

  1. 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

    Will assess through tracking data

  2. 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

    Will assess through tracking data

  3. 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

    Will assess through tracking data

  4. 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

    Will assess through tracking data

  5. 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

    Will assess through tracking data

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

    Time frame: 4 months

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

  7. 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

    Will assess through tracking data

  8. 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

    Validated measure (Acceptability of Intervention Measure)

  9. Percent of participants who received intervention during pediatric primary care visit

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

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

  10. Participants use intervention resources after the visit

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

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

Secondary outcomes

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

    Time frame: Baseline, 3-month post intervention

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

  2. 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

    Investigator developed measure (yes/no)

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

    Time frame: Baseline, 3-month post intervention

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

  4. Motivation around preventing dating violence

    Time frame: Baseline, 3-month post intervention

    Investigator developed measure, 1-5 scale (1=not motivated, 5=very motivated)

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

    Time frame: Baseline, 3-month post intervention

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

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

    Time frame: Baseline, 3-month post intervention

    Investigator developed measure, 1-5 scale (1=never; 5=always)

  7. Percentage of adolescents reporting ARA victimization and perpetration

    Time frame: Baseline, 3-month post intervention

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

  8. ARA knowledge

    Time frame: baseline, 3 months surveys (6 months total)

    3 questions assessing ARA knowledge (yes/no answer choices)

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Mickievicz, BA

CONTACT

[email protected]

14126926000

Maya Ragavan

CONTACT

[email protected]

4126926000

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

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

Registry information

Official study title

Engaging Together for Healthy Relationships Version 2.0: Multisite Pilot Intervention Trial

Acronym: ETHR2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2025
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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