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

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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

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

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+

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]

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]

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]

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 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]