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

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.

Conditions

• Psychotic Disorders
• Prodromal Symptoms
• Prodromal Schizophrenia
• Psychosis
• Family

Interventions

BEHAVIORAL

Family Focused Therapy for Clinical High Risk Youth (FFT-CHR)

Family-Focused Therapy (FFT) has been tested in randomized trials involving persons with bipolar disorder, depression, and clinical high-risk syndromes. FFT-CHR provides families with psychoeducation (sessions 1-6) about prodromal symptoms and the role of the family in helping maintain stability. Clients are supported in building coping skills and monitoring thoughts, perceptions, and mood. The family formulates a prevention action plan to prevent prodromal symptoms from escalating into full episodes. Communication training (sessions 7-13) teaches families to express positive and negative feelings, listen actively, make positive requests for change, and communicate clearly through role-playing and between-session practice. In problem solving (sessions 14-18) participants learn to break down problems into smaller ones, evaluate pros/cons, and choose solutions to implement.

BEHAVIORAL

Enhanced Care (EC)

Enhanced care (EC) has been tested as a family educational treatment in CHR and bipolar youth. The first 3 sessions of EC involve the CHR person and family (parents, siblings) and cover the same content as the psychoeducational module of FFT in abridged form. The objective of these sessions is to develop a prevention action plan. Then, the CHR person is offered monthly individual sessions with the same clinician over the next 5 months, for a total of 8 sessions over 6 months. The individual sessions focus on applying the prevention action plan when symptoms emerge, and supportive, nondirective problem-solving regarding areas of conflict with family, with peers or in the educational or occupational arena. The clinician also serves as case manager.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• David J. Miklowitz, Ph.D. · University of California, Los Angeles

• Carrie E. Bearden, Ph.D. · University of California, Los Angeles

• Kristin S. Cadenhead, M.D. · University of California, San Diego

• Scott Woods, M.D. · Yale University

• Jean M. Addington, Ph.D. · University of Calgary

• Michelle Friedman-Yakoobian, Ph.D. · Harvard Medical School/Massachusetts Mental Health Center

• Andrea M. Auther, Ph.D. · Zucker Hillside Hospital at Hofstra / Northwell Health

• Barbara A. Cornblatt, Ph.D., M.B.A. · Hofstra University / Northwell Health

• Daniel H. Mathalon, Ph.D., M.D. · University of California, San Francisco

• Holly K. Hamilton, Ph.D. · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-15

Primary Completion

2026-12-30

Completion

2026-12-31

Countries

• United States
• Canada

Study Locations