Family Acceptance Project for Relationship or Family Issues

(FAP-O Trial)

Overseen By Katie Edwards, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan

Disqualifiers: High-risk suicide, Active psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on supporting and affirming sexual and gender minority youth (SGMY) of color who experience family rejection. It tests an online program called the Family Acceptance Project - Online, which helps parents and caregivers become more accepting and supportive, improve family communication, and boost the well-being of SGMY. Participants will be divided into two groups: one will start the program immediately, while the other will join after a six-month follow-up. Families with youth who identify as SGMY, belong to a racial or ethnic minority, and experience moderate to high levels of family rejection are well-suited for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Family Acceptance Project - Online is safe for sexual and gender minority youth?

Research has shown that the Family Acceptance Project (FAP) aids LGBTQ youth by promoting family acceptance and reducing health risks. However, specific safety information for the Family Acceptance Project Online (FAP-O) is not yet available.

The project remains in the early stages of study, so researchers are still collecting detailed safety information. Early studies typically focus on understanding both the benefits and any potential issues with the program. As an educational and support program, FAP-O is less likely to present major safety concerns compared to medical treatments.

Overall, FAP-O aims to enhance family relationships and support LGBTQ youth, indicating that it is intended to be a positive and supportive experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Family Acceptance Project - Online is unique because it focuses on addressing relationship and family issues through an accessible online intervention. Unlike traditional therapy options that often require in-person sessions, this approach offers nine, 2-hour weekly sessions that participants can attend from home. Researchers are excited about this trial because it aims to enhance family dynamics and acceptance in a way that is both flexible and convenient for participants, potentially reaching a wider audience than conventional methods. By providing support to families and fostering acceptance, this project hopes to improve emotional well-being and relationships, offering insights that could shape future interventions for family-related challenges.

What evidence suggests that the Family Acceptance Project - Online is effective for improving family acceptance and mental health in sexual and gender minority youth?

Research shows that the Family Acceptance Project (FAP) helps families support and affirm young people who identify as LGBTQ+. In this trial, participants in the Immediate Treatment arm receive the intervention immediately after enrollment, while those in the Waitlist Control arm receive it after a 6-month follow-up. Studies indicate that when families become less rejecting, the mental health of these young people improves. FAP fosters stronger family connections and better communication. It also encourages acceptance and reduces family stress, leading to better outcomes for LGBTQ+ youth. These positive changes can help them feel more proud and hopeful about their future. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for sexual and gender minority youth (SGMY) aged 14 to 20, particularly from racial and ethnic minorities, who have experienced family rejection. Their caregivers must also participate. The study aims to help families support their LGBTQ+ members.

Inclusion Criteria

1. 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).

2. Identify as a person of color/belonging to a minority racial and/or ethnic group.

3. Be between the ages of 14 and 20 years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Treatment

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

9 weeks

9 online sessions

Follow-up

Participants are monitored for changes in mental health and family dynamics after treatment

6 months

Surveys conducted immediately post-treatment and at 6-month follow-up

Waitlist Control

Participants in this arm receive check-ins and resources, and will receive the intervention after 6-month follow-up

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Family Acceptance Project - Online

Trial Overview The Family Acceptance Project Online (FAP-O), a nine-week program designed to promote acceptance of SGMY by their parents/caregivers, improve family communication, increase youths' pride in being LGBTQ+, and reduce mental health issues.

How Is the Trial Designed?

Group I: Immediate Treatment Experimental Treatment 1 Intervention

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

Group II: Waitlist Control Active Control 1 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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

University of Colorado, Colorado Springs

Collaborator

Trials

20

Recruited

5,500+

University of Nebraska Lincoln

Collaborator

Trials

40

Recruited

13,200+

Published Research Related to This Trial

The program, which began as a pilot project in 1990, has successfully engaged 370 participants, demonstrating the effectiveness of collaboration between families and mental health professionals in addressing mental illness.

All family participants reported they would recommend the workshop, indicating high satisfaction and the program's success in meeting educational and support needs for families affected by mental illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Living with mental illness: professional/family collaboration. Peternelj-Taylor, CA., Hartley, VL.[2022]

Patient Family Relations (PFR) programs effectively capture patient and family concerns in hospitals, revealing that the most common issues are related to care/treatment and communication.

There is a significant mismatch (around 80%) between the data collected by PFR programs and the AHRQ Common Format, highlighting the need for improved reporting systems to better analyze safety data in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards Analytics of the Patient and Family Perspective: A Case Study and Recommendations for Data Capture of Safety and Quality Concerns. Couture, B., Fagan, M., Gershanik, E., et al.[2019]

Family psychoeducation based on the Falloon program significantly improved treatment adherence in patients with psychosis, showing increases of 43.1% at the end of the program and sustained improvements at 6 and 12 months follow-up.

The Falloon-based intervention did not lead to changes in psychopathology or clinical stability, suggesting its primary benefit lies in enhancing adherence to treatment and potentially reducing relapses over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in Treatment Adherence after Family Psychoeducation in Patients Affected by Psychosis: Preliminary Findings. Iuso, S., Severo, M., Trotta, N., et al.[2023]

Family psychoeducation is strongly supported by recent studies as an effective intervention for individuals with schizophrenia, reinforcing its inclusion in best practice guidelines.

When considering family psychoeducation, it's important to evaluate the family's and patient's interest, involvement, and specific goals, ensuring that this approach is suitable compared to other available options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on family psychoeducation for schizophrenia. Dixon, L., Adams, C., Lucksted, A.[2022]

Family interventions (FIs) for caregivers of first-episode psychosis patients significantly reduced emotional distress and burden of care, with caregivers in the experimental group reporting greater improvements in tension and overall health compared to those receiving treatment as usual.

Caregivers who participated in the family intervention also expressed higher satisfaction with the services provided, indicating that structured support for families can enhance their involvement and the quality of care received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Burden, Emotional Distress and Service Satisfaction in First Episode Psychosis. Data from the GET UP Trial. Ruggeri, M., Lasalvia, A., Santonastaso, P., et al.[2020]

Only a small percentage of families of adults with schizophrenia receive support services, with only 0.7% in a national Medicare sample and 7.1% in a state Medicaid sample accessing family therapy.

Intensive training for staff at agencies significantly improved the availability of family services, while standard didactic training did not lead to any changes, highlighting the importance of comprehensive training in implementing effective family interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Services to families of adults with schizophrenia: from treatment recommendations to dissemination. Dixon, L., Lyles, A., Scott, J., et al.[2004]

Involving patients and their families in healthcare adverse event reviews can lead to better outcomes, including reconciliation after trauma and restored trust in the healthcare system, as highlighted by interviews with 19 participants in NHS Scotland.

A collaborative and person-centered approach to these reviews not only enhances learning for healthcare providers but may also reduce the risk of similar adverse events in the future, suggesting that effective communication can decrease litigation claims.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reviews in healthcare: what matters to patients and their family? A qualitative study exploring the perspective of patients and family. McQueen, JM., Gibson, KR., Manson, M., et al.[2022]

The Patient Engagement 101 e-learning module, co-developed with input from both parents and researchers, significantly improved healthcare professionals' knowledge and confidence in engaging in patient-oriented research, as evidenced by increased test scores after completion.

Usability testing with 30 end-users showed high satisfaction and exceptional usability ratings, indicating that the module is an effective training resource for enhancing patient engagement in child health research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Codevelopment and usability testing of Patient Engagement 101: a Patient-Oriented Research Curriculum in Child Health e-learning module for health care professionals, researchers and trainees. Walsh, CM., Jones, NL., McCreath, GA., et al.[2022]

The PROSPER Consortium aims to enhance safety reporting in healthcare by integrating patient-reported outcomes (PROs) into the assessment of adverse events, recognizing the importance of the patient's perspective in understanding treatment effects.

Despite advancements in technology and increased focus on patient involvement, current safety reporting still heavily relies on healthcare professionals, which can lead to under-reporting and discrepancies between patient experiences and clinician perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. Banerjee, AK., Okun, S., Edwards, IR., et al.[2022]

The Family Reporting System (FRS) was developed to allow families of hospitalized children to report adverse events, addressing the limitations of standard clinician-initiated reporting systems that often miss many documented events.

The FRS demonstrated good face validity, excellent usability, and strong clinical utility, indicating it is an effective tool for enhancing patient safety by capturing valuable information from families about potential harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A human factors and survey methodology-based design of a web-based adverse event reporting system for families. Daniels, JP., King, AD., Cochrane, DD., et al.[2022]

Citations

1. familyproject.sfsu.edu familyproject.sfsu.edu/

Welcome to the Family Acceptance Project® | Family ... The Family Acceptance Project is a research, intervention, education and policy initiative to prevent health and mental health risks and to promote well-being ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06839859

Family Acceptance Project Online (Pilot RCT) (FAP-O) Identify mediators (e.g., increases in family bonding, reductions in internalized oppression, decreases in rejection and increases in acceptance of SGMY by ...

3. ivrl.ssw.umich.edu ivrl.ssw.umich.edu/family-acceptance-project-online-fap-o

Family Acceptance Project Online (FAP-O) The Family Acceptance Project (FAP) is a research, education, and intervention initiative that was founded more than 20 years ago to help diverse families ...

4. familyproject.sfsu.edu familyproject.sfsu.edu/publications

Selected Publications, Training and Resource Materials Overview of the Family Acceptance Project®'s work to establish a new field of family acceptance and intervention to help families learn to support their LGBTQ ...

5. withpower.com withpower.com/trial/phase-2-depression-1-2025-95c85

Family Acceptance Project for Relationship or Family Issues Research on family interventions for psychosis, like the Family Acceptance Project, shows they can reduce family stress and improve satisfaction with services.

6. familyproject.sfsu.edu familyproject.sfsu.edu/research

Research | Family Acceptance Project ® The Family Acceptance Project (FAP) uses a range of research methods including in-depth individual interviews with LGBTQ adolescents and their families.