Caregiver-Adolescent Dating Violence Prevention Intervention Pilot Trial

Relationship Abuse Prevention Intervention Implemented With Sexual and Gender Diverse Youth and Their Caregivers - Pilot Trial

This is a pilot clinical trial to test an intervention called FLARE, which is an adolescent relationship abuse prevention program for sexual and gender diverse youth and their trusted adults. FLARE comprises in-person, virtual, and asynchronous programming developed by and for caregivers and adolescents.

Study Overview

• Status: Not yet recruiting
• Conditions: Adolescent Relationship Abuse; Sexual and Gender Minorities
• Intervention / Treatment: Behavioral: FLARE; Behavioral: Resource Guide

Detailed Description

In this pilot trial, the investigators will be testing FLARE, a dating violence prevention program for sexual and gender diverse youth and their trusted adults. The study will be comparing FLARE to a wait-list control. This trial will focus on assessing acceptability, feasibility, and fidelity, as well as exploratory changes in behavioral outcomes. FLARE includes 1 in-person full day session, 2 virtual large group sessions, and several asynchronous components (website, workbook, card game). FLARE runs over a 4 week period.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya Ragavan, MD; Phone Number: 6506449954; Email: ragavanm@chp.edu
• Study Contact Backup: Name: Robert Coulter, PhD; Email: robert.ws.coulter@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
      • Contact: Erin Mickievicz, BA; Phone Number: 4126926000; Email: mickieviczee@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• SGDY eligibility includes:

  1. ages 14 to 18
  2. identifies as sexually or gender diverse (e.g., gay, lesbian, bisexual, queer, transgender, or nonbinary)
  3. uses English
  4. willing to travel to Pittsburgh for 1 in-person event; and
  5. can identify a caregiver who can also participate.

Caregivers eligibility includes:

1. age 18 or older;
2. a caregiver of an SGDY ages 14 to 18;
3. uses English;
4. willing to travel to Pittsburgh for 1 in-person event; and
5. has a child participating in this study. Caregivers can include parents or any other person whom the adolescent identifies as a trusted adult in their life. We will only enroll 1 caregiver for each SGDY; because this is a dyadic study each adolescent needs a matched participating caregiver and vice versa.

Exclusion Criteria:

• Does not meet eligibility criteria
• Incarcerated during the study
• Unable to provide verbal or REDCap consent or assent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FLARE intervention; FLARE participants will receive the intervention	Behavioral: FLARE; Adolescent relationship abuse prevention intervention for sexual and gender diverse youth and their trusted adults
Other: Wait list control; Wait list control participants will be offered the opportunity to participate in the intervention after the investigators have completed the pilot trial	Behavioral: Resource Guide; The control group will receive a resource guide and then will be able to receive FLARE after the trial is complete as a wait list control option

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Acceptability of Intervention Measure: Mean value of 4 items. Each question uses a five-point Likert scale for responses, coded with a value from 1 (Completely disagree) to 5 (Completely agree) and averaged to produce the mean value. The higher the computed mean value, the greater acceptability of the intervention.	T2 (1 month post baseline)
Trial Feasibility	Trial Consent Rate: % of individuals who assented/consented to participate out of individuals who screened eligible Trial Baseline Participation Rate: % of individuals who completed the baseline survey out of individuals who assented/consented to participate Trial Intervention Demand: % of intervention arm participants who complete the intervention Trial Retention Rate: % of participants who complete each followup survey	T1 (baseline); T2 (1 month post baseline); T3 (3 months post baseline, 2 months post T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attitudes about abusive behaviors	Recognition of Abusive Behaviors Scale: Mean of the 8 items that use 5-point Likert response options, where higher scores indicate greater recognition of abusive behaviors.	T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Attitudes towards diverse identities	Attitudes Towards Diverse Identities and Expressions: Mean value of 6 items about sexual diverse youth and mean value of 7 items about gender diverse youth. Items use 5-point Likert scales. Higher average scores indicate more positive attitudes.	T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Self-efficacy	Attitudes Towards Diverse Identities and Expressions: Mean value of 6 items about sexual diverse youth and mean value of 7 items about gender diverse youth. Items use 5-point Likert scales. Higher average scores indicate more positive attitudes.	T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Parenting confidence	Sexuality-related parenting practice confidence: Mean value of the sexuality-related parenting practice confidence subscale containing 17 items that uses a 10-point Likert scale, wherein higher mean values indicate greater confidence.	T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Caregiver self-efficacy	Affirmative Caregiving Self-Efficacy Inventory: Mean value of 20-item scale using 5-point Likert response options designed to assess caregivers' confidence in their abilities to engage in affirmative caregiver practices with SGDY. Higher mean values indicate greater self-efficacy.	T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Motivation	Motivation change ruler: The motivation change ruler assesses motivation for preventing ARA and engaging in monitoring activities with a total of 4 items and Likert scale response option. Each item will be used individually, and higher values indicate greater motivation.	T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Resource utilization	Utilization of dating/ARA resources: Utilization of dating/ARA resources is assessed using 6 items with Likert scale response options. Higher scores indicate greater utilization of dating/ARA resources.	T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Dating related parenting monitoring	Exposure to opportunities for engaging in dating/ARA monitoring activities is assessed using 5 with Likert scale response options. Higher scores indicate greater exposures to opportunities for engaging in dating/ARA monitoring activities.	T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Parenting monitoring	Mean value of the 18 items using Likert scale response options, wherein higher schools indicate greater positive parenting practices.	T1 (baseline); T3 (3 months post baseline, 2 months post T2)
LGBTQ Caregiver	LGBTQ Caregiver Acceptance Scale: Mean values will be calculated for each of the subscales, which include outness (10 items), caregiver acceptance (6 items), concealment (6 items), respect (9 items), attitudes toward parenting SGDY (4 items), supportive action (5 items). Response options use a 6-point Likert scale. Higher mean values indicate greater levels of positive outcomes, except for concealment where lower values indicate positive outcomes.	T1 (baseline); T3 (3 months post baseline, 2 months post T2)
parent-adolescent communication	5 item investigator developed measure around parent-adolescent communication on dating and dating violence. Summary score, higher mean is more communication	T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Adolescent relationship abuse	Measure of Adolescent Relationship Harassment and Abuse (MARSHA): Developed specifically by and for marginalized youth including SGDY, MARSHA assesses the frequency adolescent relationship abuse among adolescents. MARSHA included items assessing ARA victimization (39) and perpetration (39) frequency, with subscales pertain to privacy control, social control, physical abuse, sexual abuse, and intimidation. Response options include: 0 times, 1-3 times, 4-10 times, more than 10 times. Summary scores are created for each subscale by dichotomizing the items (0 vs 1) and adding them together. Higher scores indicate greater ARA.	T1 (baseline); T3 (3 months post baseline, 2 months post T2)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Richard King Mellon Foundation; Office of Violence Against Women
• Investigators: Principal Investigator: Maya I Ragavan, University of Pittsburgh; Principal Investigator: Robert Coulter, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: intervention; parental monitoring; adolescent relationship abuse; sexual and gender diverse youth
• Additional Relevant MeSH Terms: Behavior; Sexual Behavior; Coitus
• Other Study ID Numbers: STUDY25020077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No