Family Acceptance Project Online (Pilot RCT)

NCT06839859 | Recruiting Phase 2

• 2 other identifiers: HUM00264028203677
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Research shows that sexual and gender minority youth (SGMY) experience high rates of mental health problems and other challenges (e.g., social, academic). A major factor that leads to these challenges is family rejection (family behaviors and reactions that minimize, deny, ridicule and attempt to prevent or change a child's sexual orientation, gender identity and gender expression). Racial and ethnic minority youth experience the highest rates of family rejection and related health risks. The Family Acceptance Project (FAP) is a research, education, and intervention initiative that was founded more than 20 years ago to help diverse families learn to support and affirm their SGMY. FAP's Family Support Model is grounded in the lived experiences of diverse SGMY and families and uses a culture-based family support framework that enables parents and caregivers to change rejecting behaviors that FAP's research has shown contribute to health risks and increase supportive and accepting behaviors that promote well-being for SGMY. The overall goal of this research project is to evaluate a nine-week online version of FAP's Family Support Model (FAP-O). The investigators will specifically study how FAP-O:

1. 1.Promotes parent/caregiver acceptance and support of their sexual and gender minority youth.
2. 2.Increases family bonding and communication.
3. 3.Increases SGMYs' feelings of pride in being LGBTQ+ and more hopeful about the future.
4. 4.Leads to reductions in mental health problems reported by SGMY who experience family rejection.

Conditions

LGBTQ; Racial Disparities; Family Relationships; Minority Stress; Depression; Anxiety; Drug Use; Teen Dating Violence; Sexual Risk Reduction

Keywords

LGBTQ; Family Support; Parents of LGBTQ Youth; Racial/Ethnic Minority; Health Equity; Family Acceptance

Outcome Measures

Primary Outcomes (10)

• Depression (Youth and Caregivers)

  Patient Health Questionnaire (PHQ-9) modified- 9 Item measure for detecting major depression. Measured on a 4 point scale with 0= Not at all to 3= Nearly every day. Higher scores indicate more depressive symptomology.

  Past 2-weeks at pre-test (enrollment), past 2-weeks at post-test (within one week of intervention end), past 2-weeks at 6-month follow-up

• Suicidality (Youth)

  The Suicidal Ideation Attributes Scale (SIDAS): Community-based validation study of a new scale for the measurement of suicidal ideation. Suicide and Life-Threatening Behavior. A 5 item measure. Scale is 0-10 with higher scores indicating severity of suicidal ideation.

  Past month at pre-test (enrollment), past month at post-test (within one week of intervention end), past month at 6-month follow-up

• Generalized Anxiety (Youth and Caregivers)

  Generalized Anxiety Disorder Screener (GAD-7) is a self-report anxiety questionnaire of 7 items. The 4 point scale is 0= Not at all to 3= Nearly every day. Higher scores signify greater anxiety severity.

  Past 2-weeks at pre-test (enrollment), past 2-weeks at post-test (within one week of intervention end), past 2-weeks at 6-month follow-up

• Alcohol Use (Youth)

  Youth Risk Behavior Survey 2023 - Alcohol items is a 3 item measure that assesses alcohol use over the past 30 days. item 1 is a 7 point scale 0=0 days to 6= all 30 days, item 2 is a 7 point scale 0=0 days to 6= 20 or more days, and item 3 is an 8 point scale 0=I did not drink alcohol in the past 30 days to 7=10 or more drinks. Higher scores represent more alcohol use.

  Past month at pre-test (enrollment), past month at post-test (within one week of intervention end), past month at 6-month follow-up

• Drug Use (Youth)

  Youth Risk Behavior Survey 2023 - Drug use items is an 8 item measure of drug use over the past 30 days. The 6 point scale 0=0 times to 5=40 or more times. Higher scores represent more drug use.

  Past month at pre-test (enrollment), past month at post-test (within one week of intervention end), past month at 6-month follow-up

• Teen Dating Violence - Victimization (Youth)

  Measure of Adolescent Relationship Harassment and Abuse (MARSHA) - Victimization a 21 item measure with 3 subscales (privacy, social, intimidation) a 4 point scale with 0= 0 times to 3= more than 10 times. Higher scores indicate presence of unhealthy relationship behavior victimization.

  Past month at pre-test (enrollment), past month at post-test (within one week of intervention end), past month at 6-month follow-up

• Teen Dating Violence - Perpetration (Youth)

  Measure of Adolescent Relationship Harassment and Abuse (MARSHA) - Perpetration 24 item measure with 4 subscales (social, intimidation, cyber control, isolation). 4 point scale with 0= 0 times to 3= more than 10 times. Higher scores indicate unhealthy relationship behavior perpetration.

  Past month at pre-test (enrollment), past month at post-test (within one week of intervention end), past month at 6-month follow-up

• School Engagement (Youth)

  Items from Hulsey et al. (2018) is a 5 item measure with a 4 point scale 1=Not at all true of me -- 4= Extremely true of me. Higher scores indicate increased school engagement.

  No time frame at pre-test (enrollment), post-test (within one week of intervention end), or 6-month follow-up.

• Sexual Risk Taking (Youth)

  Youth Risk Behavior Survey 2023 - Sexual risk taking items over the past 30 days is a 4 item measure with item 1 having an 11 point scale 0= I have never had sex/I have had sex, but not in the past month to 10= 10 or more people and the remaining 3 items have a 5 point scale 0= 0 times to 4= 6 or more times. Higher scores indicate higher risky sexual behavior.

  Past month at pre-test (enrollment), past month at post-test (within one week of intervention end), past month at 6-month follow-up

• Caregiver perspective of youth mental health (Caregivers)

  Pediatric Symptom Checklist-17 (PSC-17) is a 17 item measure with a 3 point scale 0=Never to 2=Often. Higher scores can indicate mental health disorder characteristics.

  No time frame at pre-test (enrollment), post-test (withing one week of intervention end), or 6-month follow-up.

Other Outcomes (10)

• (Intermediary Outcome) Caregiver Accepting and Rejecting Behaviors (Youth and Caregivers)

  Time Frame: Past month at pre-test (enrollment), past month at post-test (within one week of intervention end), past month at 6-month follow-up

• (Intermediary Outcome) Outness (Youth)

  No time frame at pre-test (enrollment), post-test (within one week of intervention end), or 6-month follow-up.

• (Intermediary Outcome) Internalized homo/bi/trans phobia (Youth)

  No time frame at pre-test (enrollment), post-test (within one week of intervention end), or 6-month follow-up.

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

Participants in this arm receive the intervention (9, 2-hour weekly sessions) immediately after enrollment

Behavioral: Family Acceptance Project - Online

Waitlist Control

NO INTERVENTION

Provide check-ins, provide resources, and offer participants in this arm the same intervention program as the experimental immediate treatment group after 6-month follow-ups and measurements have been completed.

Interventions

Family Acceptance Project - Online BEHAVIORAL

a 9-week long online group program for LGBTQ+ youth of color and their parents / caregivers

Immediate Treatment

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Identify as a sexual/gender minority (including youth questioning their sexual orientation and/or gender identity AND their identity must be known to their participating caregiver).
• Identify as a person of color/belonging to a minority racial and/or ethnic group.
• Be between the ages of 14 and 25 years
• Read and speak English
• Live in the United States
• Report consistent access to a phone, tablet, and/or computer with high-speed internet access
• Report an ability to attend eight, two-hour online sessions at pre-determined times
• Report moderate to high levels of caregiver/family rejection
• Not be at high-risk for suicide
• Not be actively psychotic
• Be a caregiver (biological parent, stepparent, grandparent, aunt/uncle, or another adult who provides care) to an SGMY of color between the ages of 14 to 25
• Be over the age of 18
• Read and speak English
• Live in the United States
• Report consistent access to a phone, tablet, and/or computer with high-speed internet access.

Sponsors & Collaborators

• University of Michigan: lead
• University of Nebraska Lincoln: collaborator
• University of Colorado, Colorado Springs: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Katie Edwards, PhD

CONTACT

(734) 647-8812; edkatie@umich.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Social Work

Model Details: The study involves n=90 dyads (caregiver/LGBTQ+ youth) randomly assigned to treatment group or wait-list control group.

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 21, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)