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Caregiver-Adolescent Dating Violence Prevention Intervention Pilot Trial

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07718022
Enrollment
108
Registered
2026-07-21
Start date
2026-08-01
Completion date
2028-07-01
Last updated
2026-08-10

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

Conditions

Adolescent Relationship Abuse, Sexual and Gender Minorities

Keywords

adolescent relationship abuse, parental monitoring, intervention, sexual and gender diverse youth

Brief summary

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.

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.

Interventions

BEHAVIORALFLARE

Adolescent relationship abuse prevention intervention for sexual and gender diverse youth and their trusted adults

BEHAVIORALResource 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

Sponsors

University of Pittsburgh
Lead SponsorOTHER
Office of Violence Against Women
CollaboratorUNKNOWN
Richard King Mellon Foundation
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
AcceptabilityT2 (1 month post baseline)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.
Trial FeasibilityT1 (baseline); T2 (1 month post baseline); T3 (3 months post baseline, 2 months post T2)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

Secondary

MeasureTime frameDescription
Attitudes about abusive behaviorsT1 (baseline); T3 (3 months post baseline, 2 months post T2)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.
Attitudes towards diverse identitiesT1 (baseline); T3 (3 months post baseline, 2 months post T2)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.
Self-efficacyT1 (baseline); T3 (3 months post baseline, 2 months post T2)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.
Parenting confidenceT1 (baseline); T3 (3 months post baseline, 2 months post T2)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.
Caregiver self-efficacyT1 (baseline); T3 (3 months post baseline, 2 months post T2)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.
MotivationT1 (baseline); T3 (3 months post baseline, 2 months post T2)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.
Resource utilizationT1 (baseline); T3 (3 months post baseline, 2 months post T2)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.
Dating related parenting monitoringT1 (baseline); T3 (3 months post baseline, 2 months post T2)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.
Parenting monitoringT1 (baseline); T3 (3 months post baseline, 2 months post T2)Mean value of the 18 items using Likert scale response options, wherein higher schools indicate greater positive parenting practices.
LGBTQ CaregiverT1 (baseline); T3 (3 months post baseline, 2 months post T2)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.
parent-adolescent communicationT1 (baseline); T3 (3 months post baseline, 2 months post T2)5 item investigator developed measure around parent-adolescent communication on dating and dating violence. Summary score, higher mean is more communication
Adolescent relationship abuseT1 (baseline); T3 (3 months post baseline, 2 months post T2)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.

Countries

United States

Contacts

CONTACTMaya Ragavan, MD
ragavanm@chp.edu6506449954
CONTACTRobert Coulter, PhD
robert.ws.coulter@pitt.edu
PRINCIPAL_INVESTIGATORMaya I Ragavan

University of Pittsburgh

PRINCIPAL_INVESTIGATORRobert Coulter

University of Pittsburgh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026