Trial Summary
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.
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.
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.
12345What 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.
12356Is 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.
23457Eligibility 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
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Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: FFT-CHRExperimental Treatment1 Intervention
Family-Focused Therapy for Clinical High-Risk Individuals
Group II: Enhanced CareActive Control1 Intervention
Enhanced Care Psychoeducation for Clinical High-Risk Individuals
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San DiegoSan Diego, CA
University of California, Los AngelesLos Angeles, CA
University of California, San Francisco School of MedicineSan Francisco, CA
Yale UniversityNew Haven, CT
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Effects of family intervention on psychosocial functioning and mood symptoms of youth at high risk for bipolar disorder. [2022]Family-focused therapy (FFT) is associated with reduced rates of mood episodes among youth at high risk for bipolar disorder (BD). In a randomized trial of FFT compared to a psychoeducation-only treatment (enhanced care, EC), we sought to determine if changes in psychosocial functioning mediate mood improvements among high-risk youth.
Selection for psychosocial treatment for youth at clinical high risk for psychosis based on the North American Prodrome Longitudinal Study individualized risk calculator. [2022]Recent findings suggest that family-focused therapy (FFT) is effective for individuals at clinical high-risk for psychosis (CHR-P). As outcomes of CHR-P individuals are quite varied, certain psychosocial interventions may be differentially effective in subgroups. The present study examined change in positive symptoms for CHR-P individuals at different levels of predicted risk for conversion to psychosis who received either FFT, a brief form of family education termed enhanced care (EC) or treatment as usual.
Effects of High- versus Low-Intensity Clinician Training on Implementation of Family-Focused Therapy for Youth with Mood and Psychotic Disorders. [2022]The implementation of evidence-based psychotherapies often requires significant commitments of time and expense from mental health providers. Psychotherapy protocols with rapid and efficient training and supervision requirements may have higher levels of uptake in publicly funded clinics. Family-focused therapy (FFT) is a 4-month, 12-session treatment for bipolar and psychosis patients consisting of psychoeducation, communication training, and problem-solving skills training. In a pilot randomized trial, we compared two methods of training community clinicians in FFT: (a) high intensity (n = 24), consisting of a 6-hour in-person didactic workshop followed by telephone supervision for every session with training cases; or (b) low-intensity training (n = 23), consisting of a 4-hour online workshop covering the same material as the in-person workshop followed by telephone supervision after every third session with training cases. Of 47 clinician participants, 18 (11 randomly assigned to high intensity, 7 to low) enrolled 34 patients with mood or psychotic disorders (mean age 16.5 ± 2.0 years; 44.1% female) in an FFT implementation phase. Expert supervisors rated clinicians' fidelity to the FFT manual based on taped family sessions. We detected no differences in fidelity scores between clinicians in the two training conditions, nor did patients treated by clinicians in high- versus low-intensity training differ in end-of-treatment depression or mania symptoms. Levels of parent/offspring conflict improved in both conditions. Although based on a pilot study, the results suggest that low-intensity training of community clinicians in FFT is feasible and can result in rapid achievement of fidelity benchmarks without apparent loss of treatment efficacy.
A randomized trial of family focused therapy with populations at clinical high risk for psychosis: effects on interactional behavior. [2021]This study investigated whether family focused therapy (FFT-CHR), an 18-session intervention that consisted of psychoeducation and training in communication and problem solving, brought about greater improvements in family communication than enhanced care (EC), a 3-session psychoeducational intervention, among individuals at clinical high risk for developing psychosis.
Family-focused therapy for individuals at high clinical risk for psychosis: A confirmatory efficacy trial. [2022]Young people with attenuated psychotic symptoms (APS), brief intermittent psychosis, and/or genetic risk and functional deterioration are at high risk for developing psychotic disorders. In a prior trial, family-focused therapy for clinical high risk youth (FFT-CHR) was more effective than brief psychoeducation in reducing APS severity over 6 months. This 7-site trial will compare the efficacy of FFT-CHR to a psychoeducational and supportive intervention (enhanced care) on APS and social functioning in CHR individuals over 18 months.
A Randomized Comparison of Two Psychosocial Interventions on Family Functioning in Adolescents with Bipolar Disorder. [2021]Impairments in family functioning are associated with more severe depressive and manic symptoms, earlier recurrences, and more suicidal behaviors in early-onset bipolar disorder. This study examined whether family-focused treatment for adolescents (FFT-A) with BD I or II disorder led to greater increases in family cohesion and adaptability and decreases in conflict over 2 years compared to a briefer psychoeducational treatment (enhanced care, EC). Participants were 144 adolescents (mean age: 15.6 ± 1.4 years) with BD I or II with a mood episode in the previous 3 months. Adolescents and parents were randomized to either FFT-A (21 sessions) or EC (three sessions). Patients received guideline-based pharmacotherapy throughout the 2-year study. Trajectories of adolescent- and parent-rated family cohesion, adaptability, and conflict were analyzed over 2 years. FFT-A had greater effects on adolescent-rated family cohesion compared to EC over 2 years. Participants in FFT-A and EC reported similar improvements in family conflict across the 2 years. In the FFT-A group, low-conflict families had greater adolescent-rated family cohesion throughout the study compared to high-conflict families. High-conflict families in both treatment groups tended to show larger reductions in conflict over 2 years than low-conflict families. Family psychoeducation and skills training may improve family cohesion in the early stages of BD. Measuring levels of family conflict at the start of treatment may inform treatment responsiveness among those receiving FFT-A.
Family communication and the efficacy of family focused therapy in individuals at clinical high risk for psychosis with comorbid anxiety. [2023]Comorbid anxiety disorder is related to greater illness severity among individuals at clinical high risk (CHR) for psychosis, but its potential role in moderating response to Family Focused Therapy (FFT) for CHR is unexamined. We investigated whether comorbid anxiety disorder in CHR individuals is associated with less constructive communication during family problem-solving interactions, whether their communication skills differentially improve after FFT, and whether FFT is effective in reducing anxiety in this population.