Family-Focused Therapy for Psychosis

Recruiting at 6 trial locations

Overseen By Daniel Mathalon, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Psychotic disorder, Low IQ, Severe substance use, others

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

Compensation: Varies

Number of Visits: 24

Duration: 6 months

220 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must be willing to taper individual therapy to monthly sessions by the start of treatment.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants must be willing to reduce individual therapy sessions to once a month by the start of treatment.

What data supports the idea that Family-Focused Therapy for Psychosis is an effective treatment?

The available research shows that Family-Focused Therapy (FFT) is effective for individuals at high risk for psychosis. One study found that FFT led to greater improvements in family communication compared to a shorter family education program. Another study showed that FFT was more effective than brief psychoeducation in reducing the severity of early psychotic symptoms over six months. Additionally, FFT has been associated with reduced mood episodes in youth at high risk for bipolar disorder, suggesting its effectiveness in improving mood and social functioning. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Family-Focused Therapy for Psychosis?

Research shows that Family-Focused Therapy (FFT) can help improve communication and reduce symptoms in young people at high risk for psychosis. It has also been effective in reducing mood episodes in youth at high risk for bipolar disorder, suggesting its potential benefits for similar conditions. ^{1 2 3 4 5}

What safety data exists for Family-Focused Therapy for Psychosis?

The studies reviewed do not explicitly mention safety data for Family-Focused Therapy (FFT) for psychosis. However, they suggest that FFT is effective in reducing symptoms and improving family functioning in individuals at high risk for psychosis and bipolar disorder. The therapy involves psychoeducation, communication training, and problem-solving skills, and has been compared to enhanced care (EC) and psychoeducational interventions. No adverse safety concerns are reported in these studies, indicating that FFT is generally considered safe for participants. ^{1 2 3 5 6}

Is Family-Focused Therapy (FFT) safe for humans?

Family-Focused Therapy (FFT) has been studied in various forms and for different conditions, such as psychosis and bipolar disorder, and no safety concerns have been reported in these studies. It involves psychoeducation, communication training, and problem-solving skills, which are generally considered safe for participants. ^{1 2 3 5 6}

Is Family Focused Therapy a promising treatment for young people at high risk of psychosis?

Yes, Family Focused Therapy (FFT) is a promising treatment for young people at high risk of psychosis. Research shows that FFT helps reduce the severity of early psychotic symptoms and improves family communication. It is more effective than basic education alone and can be implemented efficiently with community clinicians. ^{2 3 4 5 7}

How is Family Focused Therapy for Clinical High Risk Youth (FFT-CHR) different from other treatments for psychosis?

Family Focused Therapy for Clinical High Risk Youth (FFT-CHR) is unique because it combines psychoeducation, communication training, and problem-solving skills in an 18-session format, which has been shown to improve family communication and reduce symptoms more effectively than brief psychoeducation alone for those at high risk of psychosis. ^{2 3 4 5 7}

What is the purpose of this trial?

The present study is a confirmatory efficacy trial of Family Focused Therapy for youth at clinical high risk for psychosis (FFT-CHR). This trial is sponsored by seven mature CHR clinical research programs from the North American Prodrome Longitudinal Study (NAPLS). The young clinical high risk sample (N = 220 youth ages 13-25) is to be followed at 6-month intervals for 18 months.

Research Team

David J Miklowitz, Ph.D.

Principal Investigator

University of California, Los Angeles

Kristin Cadenhead, MD

Principal Investigator

University of California, San Diego

Scott Woods, MD

Principal Investigator

Yale University

Jean Addington, Ph.D.

Principal Investigator

University of Calgary

Andrea M. Auther, Ph.D.

Principal Investigator

Zucker Hillside Hospital at Hofstra / Northwell Health

Barbara A. Cornblatt, Ph.D., M.B.A.

Principal Investigator

Hofstra University / Northwell Health

Daniel Mathalon, MD

Principal Investigator

University of California, San Francisco

Holly K. Hamilton, Ph.D.

Principal Investigator

University of California, San Francisco

Carrie E. Bearden, Ph.D.

Principal Investigator

University of California, Los Angeles

Michelle Friedman-Yakoobian, Ph.D.

Principal Investigator

Harvard Medical School/Massachusetts Mental Health Center

Eligibility Criteria

This trial is for English-speaking youth aged 13-25 at high risk for psychosis, who have a parent or guardian involved in their life and can consent to treatment. Participants must show early signs of psychosis but cannot have a full psychotic disorder, severe substance abuse issues, or intellectual impairment.

Inclusion Criteria

I am at high risk for psychosis, showing early symptoms not explained by another mental health condition.

Participants must be able to understand and sign an informed consent (or assent for minors) document in English

I have a parent or guardian who can join the study with me, speaks English, and we meet at least 4 hours a week.

Exclusion Criteria

Current or lifetime Axis 1 psychotic disorder by DSM-5 criteria

My IQ is below 70.

Unwilling or unable to taper individual therapy to monthly by start of treatment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Family Focused Therapy (FFT-CHR) or Enhanced Care (EC) for 6 months, including family and individual sessions

6 months

18 family sessions (FFT-CHR) or 3 family sessions and 5 individual sessions (EC)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6-month intervals

12 months

Assessments at 6, 12, and 18 months

Treatment Details

Interventions

• Enhanced Care (EC)
• Family Focused Therapy for Clinical High Risk Youth (FFT-CHR)

Trial Overview The study tests Family Focused Therapy (FFT-CHR) against Enhanced Care (EC) in young individuals showing early symptoms of psychosis. The participants will be monitored every six months over an 18-month period by established clinical research programs.

Participant Groups

Group I: FFT-CHR Experimental Treatment 1 Intervention

Family-Focused Therapy for Clinical High-Risk Individuals

Group II: Enhanced Care Active Control 1 Intervention

Enhanced Care Psychoeducation for Clinical High-Risk Individuals

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

Family-focused therapy (FFT) significantly improved family functioning over 24 months in high-risk youth for bipolar disorder compared to psychoeducation-only treatment, suggesting that family dynamics play a crucial role in managing mood symptoms.

Improvements in family functioning were found to partially mediate reductions in depressive symptoms, indicating that addressing family relationships can be an effective strategy in treating early signs of bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of family intervention on psychosocial functioning and mood symptoms of youth at high risk for bipolar disorder. Weintraub, MJ., Schneck, CD., Posta, F., et al.[2022]

Family-focused therapy (FFT) is particularly effective in reducing positive symptoms of psychosis in individuals at high risk for conversion to psychosis, as shown in a study involving 94 participants.

Higher-risk individuals showed significantly greater improvement with FFT compared to enhanced care or standard treatment, indicating that intensive interventions may be best suited for those with the highest risk levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selection for psychosocial treatment for youth at clinical high risk for psychosis based on the North American Prodrome Longitudinal Study individualized risk calculator. Worthington, MA., Miklowitz, DJ., O'Brien, M., et al.[2022]

A pilot randomized trial involving 47 clinicians and 34 patients with mood or psychotic disorders found that both high-intensity and low-intensity training methods for Family-Focused Therapy (FFT) resulted in similar fidelity to the treatment protocol.

Both training methods led to improvements in parent/offspring conflict, indicating that low-intensity training is a feasible option that does not compromise treatment efficacy for FFT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of High- versus Low-Intensity Clinician Training on Implementation of Family-Focused Therapy for Youth with Mood and Psychotic Disorders. Miklowitz, DJ., Weintraub, MJ., Posta, F., et al.[2022]

Family focused therapy (FFT-CHR), an 18-session intervention, significantly improved family communication and reduced conflict among adolescents and young adults at clinical high risk for psychosis compared to a shorter 3-session enhanced care (EC) intervention, based on a study involving 66 participants.

Participants in FFT-CHR showed notable increases in constructive communication and active listening, along with decreases in irritability and criticism, indicating that this comprehensive family skills training can effectively enhance family dynamics in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of family focused therapy with populations at clinical high risk for psychosis: effects on interactional behavior. O'Brien, MP., Miklowitz, DJ., Candan, KA., et al.[2021]

A trial involving 220 young people at high risk for psychosis will compare the effectiveness of family-focused therapy (FFT-CHR) to enhanced care over 18 months, aiming to reduce attenuated psychotic symptoms (APS) and improve social functioning.

The study hypothesizes that FFT-CHR will lead to greater improvements in APS and psychosocial functioning, particularly in individuals with a higher baseline risk for developing psychosis, potentially influencing future treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-focused therapy for individuals at high clinical risk for psychosis: A confirmatory efficacy trial. Miklowitz, DJ., Addington, JM., O'Brien, MP., et al.[2022]

Family-focused treatment for adolescents (FFT-A) significantly improved family cohesion over 2 years compared to a briefer psychoeducational treatment (enhanced care, EC) in a study of 144 adolescents with early-onset bipolar disorder.

Both FFT-A and EC led to similar reductions in family conflict, but families with lower initial conflict showed better cohesion outcomes, suggesting that assessing family dynamics at the start can help tailor treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Comparison of Two Psychosocial Interventions on Family Functioning in Adolescents with Bipolar Disorder. O'Donnell, LA., Weintraub, MJ., Ellis, AJ., et al.[2021]

Individuals at clinical high risk for psychosis with comorbid anxiety disorder initially displayed more negative and fewer positive communication behaviors during family interactions, but showed significant improvements in these behaviors after Family Focused Therapy (FFT).

FFT was effective in reducing self-reported anxiety symptoms over 12 months, demonstrating that family interventions can benefit individuals with anxiety in improving both their anxiety levels and family communication skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family communication and the efficacy of family focused therapy in individuals at clinical high risk for psychosis with comorbid anxiety. O'Brien Cannon, AC., Caporino, NE., O'Brien, MP., et al.[2023]

References

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

Effects of family intervention on psychosocial functioning and mood symptoms of youth at high risk for bipolar disorder. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Selection for psychosocial treatment for youth at clinical high risk for psychosis based on the North American Prodrome Longitudinal Study individualized risk calculator. [2022]

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

Effects of High- versus Low-Intensity Clinician Training on Implementation of Family-Focused Therapy for Youth with Mood and Psychotic Disorders. [2022]

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

A randomized trial of family focused therapy with populations at clinical high risk for psychosis: effects on interactional behavior. [2021]

5. Australia pubmed.ncbi.nlm.nih.gov

Family-focused therapy for individuals at high clinical risk for psychosis: A confirmatory efficacy trial. [2022]

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

A Randomized Comparison of Two Psychosocial Interventions on Family Functioning in Adolescents with Bipolar Disorder. [2021]

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

Family communication and the efficacy of family focused therapy in individuals at clinical high risk for psychosis with comorbid anxiety. [2023]