Adolescent Relationship AbuseNCT07718022
Caregiver-Adolescent Dating Violence Prevention Intervention Pilot Trial
A study testing FLARE and Resource Guide in people with Adolescent Relationship Abuse and Sexual and Gender Minorities, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adolescent Relationship Abuse, Sexual and Gender Minorities
- What is being tested?
- FLARE and Resource Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- Does not meet eligibility criteria
- Incarcerated during the study
- Unable to provide verbal or REDCap consent or assent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Robert Coulter, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Erin Mickievicz, BA, 4126926000, mickieviczee@upmc.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- FLARE, Resource Guide
- Keywords
- adolescent relationship abuse, parental monitoring, intervention, sexual and gender diverse youth
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLAREBehavioural
Adolescent relationship abuse prevention intervention for sexual and gender diverse youth and their trusted adults
Resource GuideBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| FLARE intervention | Experimental | FLARE participants will receive the intervention Receives: 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 Receives: Behavioral: Resource Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: T1 (baseline); T2 (1 month post baseline); T3 (3 months post baseline, 2 months post T2)
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Aug 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Relationship AbuseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Office of Violence Against Women, Richard King Mellon Foundation
- Responsible party
- Principal investigator, Maya Ragavan, University of Pittsburgh
- Investigators
- Maya I Ragavan, Principal investigator, University of PittsburghRobert Coulter, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718022
- Sponsor's protocol ID
- STUDY25020077
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Abuse Prevention Intervention Implemented With Sexual and Gender Diverse Youth and Their Caregivers - Pilot Trial
- ClinicalTrials.gov ID
- NCT07718022
- Acronym / sponsor ID
- STUDY25020077
- Keywords
- adolescent relationship abuse, parental monitoring, intervention, sexual and gender diverse youth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Office of Violence Against Women, Richard King Mellon Foundation
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLARE intervention | Experimental | Behavioral: FLAREFLARE participants will receive the intervention |
| Wait list control | Other | Behavioral: Resource GuideWait list control participants will be offered the opportunity to participate in the intervention after the investigators have completed the pilot trial |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- SGDY 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
Key exclusion criteria (3 listed)
- Does not meet eligibility criteria
- Incarcerated during the study
- Unable to provide verbal or REDCap consent or assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLAREAdolescent relationship abuse prevention intervention for sexual and gender diverse youth and their trusted adults | Behavioural | FLARE intervention |
| Resource GuideThe 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 | Behavioural | Wait list control |
Primary outcome
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.
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
12 secondary outcomes
Attitudes about abusive behaviors
Time frame: T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Attitudes towards diverse identities
Time frame: T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Self-efficacy
Time frame: T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Parenting confidence
Time frame: T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Caregiver self-efficacy
Time frame: T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Motivation
Time frame: T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Resource utilization
Time frame: T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Dating related parenting monitoring
Time frame: T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Parenting monitoring
Time frame: T1 (baseline); T3 (3 months post baseline, 2 months post T2)
LGBTQ Caregiver
Time frame: T1 (baseline); T3 (3 months post baseline, 2 months post T2)
parent-adolescent communication
Time frame: T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Adolescent relationship abuse
Time frame: T1 (baseline); T3 (3 months post baseline, 2 months post T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Coulter, PhD contact
Maya I Ragavan principal investigator
University of Pittsburgh
Robert Coulter principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLARE and Resource Guide in people with Adolescent Relationship Abuse and Sexual and Gender Minorities, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Ragavan, MD (6506449954, ragavanm@chp.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: T2 (1 month post baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.