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NCT Number: NCT07718022

Caregiver-Adolescent Dating Violence Prevention Intervention 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.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location contact

Erin Mickievicz, BA

CONTACT

[email protected]

4126926000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

FLARE

Behavioral

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

Resource Guide

Behavioral

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

Primary outcomes

  1. Acceptability

    Time frame: T2 (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.

  2. Trial Feasibility

    Time frame: T1 (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 outcomes

  1. Attitudes about abusive behaviors

    Time frame: T1 (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.

  2. Attitudes towards diverse identities

    Time frame: T1 (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.

  3. Self-efficacy

    Time frame: T1 (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.

  4. Parenting confidence

    Time frame: T1 (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.

  5. Caregiver self-efficacy

    Time frame: T1 (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.

  6. Motivation

    Time frame: T1 (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.

  7. Resource utilization

    Time frame: T1 (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.

  8. Dating related parenting monitoring

    Time frame: T1 (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.

  9. Parenting monitoring

    Time frame: T1 (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.

  10. LGBTQ Caregiver

    Time frame: T1 (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.

  11. parent-adolescent communication

    Time frame: T1 (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

  12. Adolescent relationship abuse

    Time frame: T1 (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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maya Ragavan, MD

CONTACT

[email protected]

6506449954

Robert Coulter, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Office of Violence Against Women
  • Richard King Mellon Foundation

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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