Engaging Together for Healthy Relationships

Domestic Violence Clinical Trial

— ETHR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880979
• Other study ID #: STUDY22060047
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Domestic Violence
• Violence in Adolescence

Intervention

Behavioral:
• Engaging 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
• Regular well child care
Participants will receive their regularly scheduled well-child care

Locations

Country	Name	City	State
United States	CCP South Hills	Monongahela	Pennsylvania
United States	Primary Care Center Oakland	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Self-efficacy in preventing adolescent relationship abuse (ARA), change in outcome between baseline and 3 months	Self-efficacy around ARA prevention, 1-5 scale (5=higher self-efficacy)	Baseline, 3-month post intervention
Secondary	Percentage of participants who utilize ARA resources at each measurement point, change in outcome over time	Investigator developed measure (yes/no)	Baseline, 1 month post intervention, 3 month post-intervention
Secondary	Attitudes about ARA, change in outcome between baseline and 3 months	Attitudes about Abusive Relationships, 1-5 scale (1=not abusive, 5=very abusive)	Baseline, 3-month post intervention
Secondary	Parent-adolescent communication around dating and ARA, change in outcome over time	Investigator developed measure, yes/no answer choices (yes=has communicated, no=has not communicated)	Baseline, 3-month post intervention
Secondary	Parental monitoring around dating and ARA, change in outcome over time	Parenting Practices Scale (never to always; 1=never, 5=always)	Baseline, 3-month post intervention
Secondary	Percentage of adolescents reporting ARA victimization and perpetration	CADRI Short Form 1-5 scale (never to everyday)	Baseline, 3-month post intervention