Family-Focused Therapy for Psychosis

Not currently recruiting at 6 trial locations
DM
DJ
DM
Overseen ByDaniel Mathalon, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Family Focused Therapy, which involves families in therapy sessions to help young people at high risk of developing psychosis. The goal is to determine if this approach can effectively reduce the risk of psychosis over time. The trial compares two care methods: the experimental Family Focused Therapy for Clinical High Risk Youth (FFT-CHR) and an enhanced care routine that includes psychoeducation. Ideal participants are youth who have recently experienced an increase in mild psychosis symptoms, have a family history of psychosis, or show brief psychotic episodes, and have a parent or guardian willing to participate in therapy sessions. As an unphased trial, this study offers participants the chance to contribute to innovative research that could shape future psychosis prevention strategies.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Family Focused Therapy for Clinical High Risk Youth (FFT-CHR) is generally well-tolerated. In studies with young people at high risk for developing psychosis, no major negative effects have been reported. This therapy involves family members in the treatment, helping to create a supportive environment for the participant. The absence of serious side effects in previous research suggests that FFT-CHR is a safe option for those considering joining the trial.12345

Why are researchers excited about this trial?

Researchers are excited about Family Focused Therapy for Clinical High Risk Youth (FFT-CHR) because it offers a unique approach to supporting young people at risk of developing psychosis. Unlike standard treatments for psychosis, which often focus on medication and individual therapy, FFT-CHR involves the entire family in the therapy process, aiming to improve family communication and problem-solving skills. This holistic approach not only addresses the individual's needs but also strengthens the family unit, potentially reducing stressors and improving long-term outcomes. By involving family members, FFT-CHR seeks to create a supportive environment that can help prevent the progression of psychosis.

What evidence suggests that this trial's treatments could be effective for psychosis?

Research has shown that Family Focused Therapy for Clinical High Risk Youth (FFT-CHR), one of the treatments in this trial, can help young people at high risk of developing psychosis. Studies have found that FFT-CHR can improve symptoms and daily life. For example, one study found that young people who participated in family education had better results than those who did not. Another study with youth showing early signs of psychosis also reported positive outcomes, indicating that involving families in therapy can significantly impact. Overall, evidence supports FFT-CHR as a promising way to reduce the risk of psychosis in young people. Participants in this trial may receive FFT-CHR or Enhanced Care, which serves as an active comparator.23467

Who Is on the Research Team?

DJ

David J Miklowitz, Ph.D.

Principal Investigator

University of California, Los Angeles

KS

Kristin Cadenhead, MD

Principal Investigator

University of California, San Diego

SW

Scott Woods, MD

Principal Investigator

Yale University

JM

Jean Addington, Ph.D.

Principal Investigator

University of Calgary

AM

Andrea M. Auther, Ph.D.

Principal Investigator

Zucker Hillside Hospital at Hofstra / Northwell Health

BA

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

Principal Investigator

Hofstra University / Northwell Health

DH

Daniel Mathalon, MD

Principal Investigator

University of California, San Francisco

HK

Holly K. Hamilton, Ph.D.

Principal Investigator

University of California, San Francisco

CE

Carrie E. Bearden, Ph.D.

Principal Investigator

University of California, Los Angeles

MF

Michelle Friedman-Yakoobian, Ph.D.

Principal Investigator

Harvard Medical School/Massachusetts Mental Health Center

Are You a Good Fit for This Trial?

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
See 2 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: FFT-CHRExperimental Treatment1 Intervention
Group II: Enhanced CareActive Control1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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]
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.
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]
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.
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]

Citations

Family-focused therapy for individuals at high clinical risk ...Young people with attenuated psychotic symptoms (APS), brief intermittent psychosis, and/or genetic risk and functional deterioration are at high risk for ...
Family-focused therapy for individuals at clinical high risk for ...The sample included 103 youth or young adults (ages 12–30 years) who had attenuated positive symptoms of psychosis. Families participated in a randomized trial ...
Prevention Trial of Family Focused Treatment in Youth at ...Further, an open trial of family psychoeducation for youth at risk for psychosis demonstrated symptomatic and functional improvements relative to baseline ...
Family-Focused Therapy for Individuals at High ...The present study is a confirmatory efficacy trial of Family Focused Therapy for youth at clinical high risk for psychosis (FFT-CHR).
A Randomized Trial of Family Focused Therapy With ...A prior study found that 35% of a sample of caregivers of youths at clinical high risk (CHR) for psychosis could be classified as high EE and that the majority ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/34427047/
Family-focused therapy for individuals at high clinical risk for ...Results of the trial will inform treatment guidelines for individuals at high risk for psychosis.
Family-Focused Therapy for Psychosis · Info for ParticipantsThe present study is a confirmatory efficacy trial of Family Focused Therapy for youth at clinical high risk for psychosis (FFT-CHR).
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