Active — Not RecruitingNot Applicable

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

United States220 participantsStarted 2021-01-15

Plain-language 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 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.

Who can participate

Age range13 Years – 25 Years

SexALL

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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.

What they're measuring

The Structured Interview for Psychosis-risk Syndromes Scale of Prodromal Symptoms (SOPS)

Timeframe: 0, 6, 12, and 18 months

Trial details

NCT IDNCT04338152

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

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