Family Engagement for Early Psychosis

(FAMES Trial)

Recruiting at 3 trial locations

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

Age: Any Age

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance how family members and support people engage with mental health services for individuals in the early stages of psychosis. It examines whether a culturally sensitive approach, delivered by family peers, can reduce stress and improve outcomes. One group of participants will receive regular communication with positive messages and helpful resources, while another group will participate in the full FAMES program (Family Engagement for Early Psychosis). Ideal participants are family members or support persons of individuals who have been receiving specialized care for psychosis for six months or less. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in mental health support.

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 prior data suggests that this protocol is safe for family engagement in early psychosis?

Research has shown that involving families in the early stages of psychosis treatment is very effective. Studies indicate that these methods improve outcomes for individuals experiencing early psychosis. With family involvement, patients often develop better social skills and a deeper understanding of their condition.

While specific safety data for the FAMES program is not available, similar family-focused approaches have been well-received. These programs typically emphasize communication and support rather than medication, generally resulting in fewer risks.

The FAMES program encourages family members to play a supportive role, which has been shown to reduce stress and enhance the treatment experience for both patients and their families. Although direct safety data for FAMES is lacking, the program's supportive nature suggests it is low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FAMES intervention for early psychosis because it actively engages families and support persons through consistent communication, which is not a typical focus of standard treatments. Unlike traditional options that may primarily target the individual with medication and therapy, FAMES incorporates family involvement via text, email, or phone calls, offering positive messaging and psychoeducation. This method aims to enhance support networks and improve overall outcomes by fostering a more supportive environment, potentially leading to better adherence to treatment and a stronger recovery trajectory for individuals with early psychosis.

What evidence suggests that the FAMES intervention could be effective for early psychosis?

This trial will compare two approaches to family involvement in treating early psychosis. Research has shown that involving family in treatment can greatly improve outcomes. Studies have found that family-focused approaches lower the chances of relapse for those with psychosis and reduce stress for their families. Family support is linked to better treatment participation and improved mental health for patients. These interventions also lessen the burden and stress on caregivers. Overall, including family in treatment has proven to make a positive difference for people experiencing early psychosis. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10955207/

a systematic review and component network meta-analysis Primary outcomes were negative and positive psychotic symptoms at 3-month and 1-year follow-up and treatment dropouts. Secondary outcomes were ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0920996425000064

Systematic review and meta-analysis of family-based ... Conclusions. Family interventions for early psychosis benefit both family carers and their relatives diagnosed with psychosis when compared with usual care.

3. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2017.00371/full

Do Family Interventions Improve Outcomes in Early ... Family interventions for psychosis (FIp) are effective in reducing service user relapse and carer distress in people with schizophrenia-spectrum conditions.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03919760

Study Details | NCT03919760 | Early Psychosis Intervention This study is designed to improve the delivery of recovery-oriented evidence-based EPI care in Ontario, and improve person-, system-, and economic-level ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9434430/

Outcomes During and After Early Intervention Services for ... Outcomes during and after early intervention services for first-episode psychosis: results over 5 years from the RAISE-ETP site-randomized trial.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8792869/

Early Intervention in Psychosis services: A systematic review ... This systematic review and narrative synthesis aims to identify barriers and facilitators to EIP service implementation.

7. mghpsychnews.org mghpsychnews.org/improved-insight-first-episode-psychosis/

Improvements in Insight and Outcomes with Early ... Early intervention with NAVIGATE program for first episode psychosis improves insight and social functioning. Previous studies have observed that impaired ...

8. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2018.00406/full

Editorial: Family Interventions in Psychosis Change ... The papers in this Research Topic speak to the broad evidence base in support of the rationale and delivery of family interventions with early psychosis ...

9. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ps.202100506

A Scoping Review of Measures Used in Early Intervention ... A review of measures used in early intervention services (EISs) for psychosis identified 172 measures of 27 broad domains from 115 studies; all ...