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Engaging Together for Healthy Relationships

Engaging Together for Healthy Relationships: A Pilot Trial to Test a Brief Dating Violence Prevention Intervention for Pediatric Primary Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05880979
Acronym
ETHR
Enrollment
102
Registered
2023-05-30
Start date
2023-07-01
Completion date
2024-12-01
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Domestic Violence, Violence in Adolescence

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.

Interventions

BEHAVIORALEngaging 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

BEHAVIORALRegular well child care

Participants will receive their regularly scheduled well-child care

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

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.

Intervention model description

Randomization will occur at the provider-level

Eligibility

Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
Yes

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 1\) Does not need inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Percentage of participants who strongly agree or agree that the intervention is acceptable using a 4-item validated measure (Acceptability of Intervention Measure)Through completion of completing immediate post-visit surveys, an average of 6 monthsValidated measure (Acceptability of Intervention Measure)
Percentage of participants who are consented out of the total who are eligibleThrough completion of study recruitment, an average of 6 monthsWill assess through tracking data
Percentage of participants who complete the baseline survey out of the total who consentedThrough completion of completing baseline surveys, an average of 6 monthsWill assess through tracking data
Percentage of participants who complete the well-visit out of the total who consentedThrough completion of completing well-visits, an average of 6 monthsWill assess through tracking data
Percentage of participants who complete the immediate post-intervention survey out of the total who consentedThrough completion of completing post-intervention survey, an average of 7 monthsWill assess through tracking data
Percentage of participants who complete the 1-month post-intervention survey out of the total who consented4 monthsThrough completion of completing 1- month post-intervention survey, an average of 8 months
Percentage of participants who complete the 3-month post-intervention survey out of the total who consentedThrough completion of completing 3 month post-intervention survey, an average of 12 monthsWill assess through tracking data
Percentage of participants who are eligible out of the total who are approachedThrough completion of study recruitment, an average of 6 monthsWill assess through tracking data

Secondary

MeasureTime frameDescription
Percentage of participants who utilize ARA resources at each measurement point, change in outcome over timeBaseline, 1 month post intervention, 3 month post-interventionInvestigator developed measure (yes/no)
Attitudes about ARA, change in outcome between baseline and 3 monthsBaseline, 3-month post interventionAttitudes about Abusive Relationships, 1-5 scale (1=not abusive, 5=very abusive)
Parent-adolescent communication around dating and ARA, change in outcome over timeBaseline, 3-month post interventionInvestigator developed measure, yes/no answer choices (yes=has communicated, no=has not communicated)
Parental monitoring around dating and ARA, change in outcome over timeBaseline, 3-month post interventionParenting Practices Scale (never to always; 1=never, 5=always)
Percentage of adolescents reporting ARA victimization and perpetrationBaseline, 3-month post interventionCADRI Short Form 1-5 scale (never to everyday)
Self-efficacy in preventing adolescent relationship abuse (ARA), change in outcome between baseline and 3 monthsBaseline, 3-month post interventionSelf-efficacy around ARA prevention, 1-5 scale (5=higher self-efficacy)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026