NCT07718022

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 16, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

adolescent relationship abuseparental monitoringinterventionsexual and gender diverse youth

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Attitudes about abusive behaviors

    T1 (baseline); T3 (3 months post baseline, 2 months post T2)

  • Attitudes towards diverse identities

    T1 (baseline); T3 (3 months post baseline, 2 months post T2)

  • Self-efficacy

    T1 (baseline); T3 (3 months post baseline, 2 months post T2)

  • Parenting confidence

    T1 (baseline); T3 (3 months post baseline, 2 months post T2)

  • Caregiver self-efficacy

    T1 (baseline); T3 (3 months post baseline, 2 months post T2)

  • +7 more secondary outcomes

Study Arms (2)

FLARE intervention

EXPERIMENTAL

FLARE participants will receive the intervention

Behavioral: FLARE

Wait list control

OTHER

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

Interventions

Resource GuideBEHAVIORAL

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

Wait list control
FLAREBEHAVIORAL

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

FLARE intervention

Eligibility Criteria

Age14 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • SGDY eligibility includes:
  • ages 14 to 18
  • identifies as sexually or gender diverse (e.g., gay, lesbian, bisexual, queer, transgender, or nonbinary)
  • uses English
  • willing to travel to Pittsburgh for 1 in-person event; and
  • can identify a caregiver who can also participate.
  • Caregivers eligibility includes:
  • age 18 or older;
  • a caregiver of an SGDY ages 14 to 18;
  • uses English;
  • willing to travel to Pittsburgh for 1 in-person event; and
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Maya I Ragavan

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
  • Robert Coulter

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Ragavan, MD

CONTACT

Robert Coulter, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 21, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations