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NCT04338152Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 26 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
220 (estimated)
First submitted
3 Apr 2020
Start date
15 Jan 2021
Primary completion date
30 Dec 2026
Lead sponsor
University of California, Los Angeles
NCT number
NCT04338152

What you commit to

  • Study type: Interventional
  • Planned participants: 220
  • From 15 Jan 2021 to the primary completion date, 30 Dec 2026
  • 7 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Unwilling or unable to taper individual therapy to monthly by start of treatment

Other illness

  • Current or lifetime Axis 1 psychotic disorder by DSM-5 criteria
  • 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.

Other

  • Impaired intellectual functioning (IQ\<70)

Who the study is looking for

  • 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.

Age in the registry: 13 years to 25 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Of Calgary
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
Harvard University/Beth Israel Deconess Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
University of California, Los Angeles
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Yale University
Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status
Zucker Hillside Hospital
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
University of California San Diego
Coordinator of this site? Confirm its status
San DiegoUnited StatesUnknown status
University of California, San Francisco School of Medicine
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.