Can family therapy prevent psychosis in At-Risk youth?
NCT ID NCT04338152
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a family-focused therapy for 220 youth aged 13-25 who show early signs of psychosis risk. The therapy aims to reduce symptoms and prevent the development of full psychosis over 18 months. Participants receive either the family therapy or a comparison treatment, with regular check-ins to track progress.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 220 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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13 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Participants must be able to understand and sign an informed consent (or assent for minors) document in English; 2. 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 3. 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. Exclusion Criteria 1. Current or lifetime Axis 1 psychotic disorder by DSM-5 criteria 2. Impaired intellectual functioning (IQ\<70) 3. Unwilling or unable to taper individual therapy to monthly by start of treatment 4. Past or current history of a clinically significant medical or central nervous system disorder that may contribute to CHR symptoms or confound assessment 5. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Harvard University/Beth Israel Deconess Medical Center
Boston, Massachusetts, 02215, United States
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University of Calgary
Calgary, Alberta, Canada
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University of California, Los Angeles
Los Angeles, California, 90095, United States
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University of California, San Diego
San Diego, California, 92093, United States
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University of California, San Francisco School of Medicine
San Francisco, California, 94121, United States
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Yale University
New Haven, Connecticut, 06519, United States
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Zucker Hillside Hospital
New York, New York, 11004, United States
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Other studies related to the condition(s) this trial covers.
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