Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial

Running, not enrolling · Not applicable

Conditions studied: Psychotic Disorders, Prodromal Symptoms, Prodromal Schizophrenia, Psychosis, Family

In brief

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.

Key facts

Study ID

NCT04338152

Run by

University of California, Los Angeles

People needed

220

Starts

2021-01-15

Expected to finish

2026-12-31

Last updated by the study team

2026-01-26

Who can join

Age: 13 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be able to understand and sign an informed consent (or assent for minors) document in English;
• Youth has at least one parent or legal guardian who participants sees often enough (minimum 4 hours/week) that family intervention is sensible, who is English-speaking, and who consents to study participation and treatment sessions; and
• Youth currently meets criteria for clinical high-risk (CHR) for psychosis, with attenuated positive symptoms that have begun or worsened in the past 12 months, genetic risk and deterioration, or brief intermittent psychotic symptoms. Eligible participants may meet DSM-5 criteria for any non-psychotic disorder (e.g. major depression, anxiety disorders, ADHD), as long as the disorder does not clearly account for the presence of psychosis risk symptoms.

You may not qualify if…

• Current or lifetime Axis 1 psychotic disorder by DSM-5 criteria
• Impaired intellectual functioning (IQ<70)
• Unwilling or unable to taper individual therapy to monthly by start of treatment
• Past or current history of a clinically significant medical or central nervous system disorder that may contribute to CHR symptoms or confound assessment
• Severe substance or alcohol use disorder within the past 6 months, and/or substance use (including cannabis) is causally related to recent onset of CHR symptoms so as to confound prodromal diagnostic determination.
• If either an exclusionary medical condition or an incidental medical condition is suspected, the participant will be advised to consult with their physician or will be referred to a specialist. Eligibility for the trial will be reconsidered if the medical condition has been treated to remission and the subject still meets CHR criteria.

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• University of California, San Diego — San Diego, California, United States
• University of California, San Francisco School of Medicine — San Francisco, California, United States
• Yale University — New Haven, Connecticut, United States
• Harvard University/Beth Israel Deconess Medical Center — Boston, Massachusetts, United States
• Zucker Hillside Hospital — New York, New York, United States
• University of Calgary — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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