Status:
ACTIVE_NOT_RECRUITING
Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Psychotic Disorders
Prodromal Symptoms
Eligibility:
All Genders
13-25 years
Phase:
NA
Brief Summary
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 prog...
Detailed Description
This randomized, single blind trial will compare outcomes from a 6-month FFT-CHR intervention and a control condition (enhanced care, or EC) matched to the FFT-CHR in duration (6 months) and access to...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04338152
Start Date
January 15 2021
End Date
December 31 2026
Last Update
January 14 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
University of California, San Diego
San Diego, California, United States, 92093
3
University of California, San Francisco School of Medicine
San Francisco, California, United States, 94121
4
Yale University
New Haven, Connecticut, United States, 06519