Family Acceptance Project for Relationship or Family Issues

(FAP-O Trial)

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Michigan

Disqualifiers: High-risk suicide, Active psychosis, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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. Promotes parent/caregiver acceptance and support of their sexual and gender minority youth. 2. Increases family bonding and communication. 3. Increases SGMYs' feelings of pride in being LGBTQ+ and more hopeful about the future. 4. Leads to reductions in mental health problems reported by SGMY who experience family rejection. Before receiving FAP-O's family support services, racial and ethnic minority SGMY (ages 14 to 20) and their caregivers will complete an initial pre-test survey. After completing this initial (baseline) survey, half of the families will participate in program sessions. Following the first round of sessions, all participants will complete an immediate follow-up survey, with an additional survey conducted six months after this. These surveys help us learn if FAP-O impacts the project's goals above. After the final survey, the other half of the families will attend program sessions. The investigators will also ask SGMY and caregivers to share what they liked about the program and their guidance for enhancing it.

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 data supports the effectiveness of the Family Acceptance Project - Online treatment 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. Family psychoeducation has also been effective in improving treatment adherence and reducing relapses in mental health conditions. ^{1 2 3 4 5}

Is the Family Acceptance Project safe for participants?

The available research does not provide specific safety data for the Family Acceptance Project or its variations. However, general safety reporting systems emphasize the importance of capturing patient and family perspectives to improve safety in healthcare settings. ^{6 7 8 9 10}

Research Team

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Family Acceptance Project - Online (Behavioural Intervention)

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.

Participant Groups

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+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

University of Colorado, Colorado Springs

Collaborator

Trials

20

Recruited

5,500+

University of Nebraska Lincoln

Collaborator

Trials

40

Recruited

13,200+

Findings from Research

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Family Burden, Emotional Distress and Service Satisfaction in First Episode Psychosis. Data from the GET UP Trial. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Services to families of adults with schizophrenia: from treatment recommendations to dissemination. [2004]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Improvements in Treatment Adherence after Family Psychoeducation in Patients Affected by Psychosis: Preliminary Findings. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Living with mental illness: professional/family collaboration. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Update on family psychoeducation for schizophrenia. [2022]

6. United States 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. [2019]

7. Canada 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. [2022]

8. England 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. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

A human factors and survey methodology-based design of a web-based adverse event reporting system for families. [2022]