Family Engagement for Early Psychosis

(FAMES Trial)

Recruiting at 3 trial locations

Overseen By Bryony Stokes, Program Manager, M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington State University

Disqualifiers: Consent process, Language barriers

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

Compensation: Varies

Number of Visits: Unknown

900 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment FAMES for early psychosis?

Research shows that involving family members in the treatment of early psychosis can help prevent relapses and support recovery. Family engagement also increases the likelihood that patients will stay involved in their treatment, which is crucial for their progress. ^{1 2 3 4 5}

Is family psychoeducation safe for treating early psychosis?

Family psychoeducation has been used safely for many years to help people with schizophrenia and bipolar disorder, and it supports both patients and their families. It helps prevent relapses and promotes recovery without any known safety concerns. ^{2 6 7 8 9}

How is the FAMES treatment for early psychosis different from other treatments?

FAMES is unique because it focuses on engaging family members in the treatment process, which can improve the engagement and outcomes for individuals with early psychosis. Unlike traditional treatments that may not involve family, FAMES emphasizes family support and education, recognizing the critical role families play in recovery. ^{2 3 10 11 12}

What is the purpose of this trial?

Family members/support persons' engagement in mental health services has been linked to reduced burden and stress and improves engagement and outcomes in individuals in the early stages of psychosis. The goal of FAMES is to address low family member/support person engagement in services. FAMES will also address disparities in coordinated specialty care (CSC) by using a culturally responsive family engagement strategy to be delivered by family peers.

Eligibility Criteria

This trial is for family members or support persons of individuals in the early stages of psychosis. It aims to improve their engagement in mental health services, which can help reduce stress and enhance outcomes for those with psychosis.

Inclusion Criteria

Family member/support person of an individual enrolled in coordinated specialty care services for equal to or less than 6 months

Did not participate in the attention control condition during the active implementation period (FAMES)

Exclusion Criteria

If they do not understand the consent process

I do not speak or understand English or Spanish.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Attention Control Condition

Participants receive weekly communication for 12 weeks including positive messaging, community resources, appointment reminders, and psychoeducation

12 weeks

Weekly communication via text, email, or phone call

FAMES Condition

Participants receive a culturally responsive family engagement strategy including a modified cultural formulation interview, brief check-ins, psychoeducation, and access to an online community

30 months

Follow-up

Participants are monitored for engagement and outcomes in coordinated specialty care services

3 months

Treatment Details

Interventions

• FAMES

Trial Overview The FAMES (Family Engagement Strategy) intervention is being tested against a control group to see if it increases family/support person involvement in coordinated specialty care (CSC), especially focusing on cultural responsiveness.

Participant Groups

Group I: Attention Control Condition Active Control 1 Intervention

225 dyads (family members/support persons and individuals receiving services for psychosis) will be recruited over a period of 18 months to receive 12 weeks of weekly communication via text, email or phone call, which includes positive messaging, community resources, appointment reminders, and psychoeducation.

Group II: Active Condition Active Control 1 Intervention

This arm lasts for 30 months during each wave of the clustered randomized stepped wedge design. 225 participants will receive the FAMES intervention.

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

A psychoeducational family intervention following a first episode of psychosis helps both patients and their families develop insight and acceptance of the illness, which is crucial for recognizing the need for support.

Participants reported improved communication skills and problem-solving abilities, as well as increased independence for patients, highlighting the intervention's effectiveness in fostering better family dynamics and personal responsibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participants' perceived benefits of family intervention following a first episode of psychosis: a qualitative study. Nilsen, L., Frich, JC., Friis, S., et al.[2016]

Psychoeducation for families of individuals experiencing first-episode psychosis is effective in preventing relapse and promoting recovery, while also helping families feel less isolated and more informed.

Inpatient staff play a crucial role in providing immediate support and information to families during the acute phase of the illness, which is essential alongside community-based psychoeducation programs later on.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervening Early with Family Members during First-Episode Psychosis: An Evaluation of Mental Health Nursing Psychoeducation within an Inpatient Unit. Petrakis, M., Laxton, S.[2019]

In a study of 349 service users in early psychosis treatment, those whose family members were engaged in their care during the first month were significantly more likely to stay engaged and attend appointments over the next 7 months.

For every additional appointment attended by family members in the first 24 months, the likelihood of service users remaining engaged increased by 14%, highlighting the crucial role of family involvement in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking a Look at How Family Member Engagement Influences Service User Engagement in New Journeys: a Coordinated Specialty Care Program. Oluwoye, O., Fraser, ER., Kordas, G.[2023]

Family psychoeducation has evolved over 40 years into a highly effective treatment for schizophrenia, reducing relapse rates by 50-60% compared to standard treatment, based on over 100 outcome studies.

The approach focuses on engaging family members as partners in care, enhancing social functioning and well-being, and has shown promising results in early intervention for first episode and prodromal psychosis, leading to significant improvements in functioning and prevention of psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Interventions for Schizophrenia and the Psychoses: A Review. McFarlane, WR.[2022]

Family-focused therapy for individuals at clinical high risk for psychosis (FFT-CHR) was delivered with high fidelity by newly trained clinicians, with 90% of treatment sessions rated above acceptable thresholds.

FFT-CHR emphasized communication and problem-solving skills more than enhanced care, suggesting it may be a more effective psychosocial intervention for preventing psychosis in youth and young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-focused therapy for individuals at clinical high risk for psychosis: treatment fidelity within a multisite randomized trial. Marvin, SE., Miklowitz, DJ., O'Brien, MP., et al.[2021]

Family support is crucial in Early Psychosis Intervention (EPI) programs, but its implementation is low due to varying family needs and preferences regarding intervention timing, length, and content, as highlighted in a review of 7 studies.

To improve family support uptake, flexible and tiered approaches to care are recommended, as many families may not need the intensive psychoeducational programs typically offered. More research is needed to determine the effectiveness of these varied support models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to implementing family support and education in Early Psychosis Intervention programmes: A systematic review. Selick, A., Durbin, J., Vu, N., et al.[2018]

Family members of individuals with early psychosis play a crucial role in their loved ones' engagement with treatment, but they face significant stress and uncertainty in this role, as revealed through interviews with 18 family members.

Supportive elements of the clinical program, such as ongoing outreach, communication, and individualized care, are highly valued by families, highlighting the need for tailored support to help them manage their responsibilities and emotional challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family member engagement with early psychosis specialty care. Lucksted, A., Stevenson, J., Nossel, I., et al.[2019]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Participants' perceived benefits of family intervention following a first episode of psychosis: a qualitative study. [2016]

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

Intervening Early with Family Members during First-Episode Psychosis: An Evaluation of Mental Health Nursing Psychoeducation within an Inpatient Unit. [2019]

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

Taking a Look at How Family Member Engagement Influences Service User Engagement in New Journeys: a Coordinated Specialty Care Program. [2023]

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

Family Involvement in the Clinical Care of Clients With First-Episode Psychosis in the RAISE Connection Program. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Implementing family involvement in the treatment of patients with psychosis: a systematic review of facilitating and hindering factors. [2023]

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

Family Interventions for Schizophrenia and the Psychoses: A Review. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Family-focused therapy for individuals at clinical high risk for psychosis: treatment fidelity within a multisite randomized trial. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Brief Mindfulness-Based Family Psychoeducation Intervention for Chinese Young Adults With First Episode Psychosis: A Study Protocol. [2023]

9. Denmark pubmed.ncbi.nlm.nih.gov

[Psychoeducation and multifamily groups for patients with first-episode psychosis]. [2007]

10. England pubmed.ncbi.nlm.nih.gov

Family interventions in early psychosis: specificity and effectiveness. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to implementing family support and education in Early Psychosis Intervention programmes: A systematic review. [2018]

12. Australia pubmed.ncbi.nlm.nih.gov

Family member engagement with early psychosis specialty care. [2019]