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

NAActive, not recruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

January 15, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2026

Conditions
Psychotic DisordersProdromal SymptomsProdromal SchizophreniaPsychosisFamily
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.

Trial Locations (7)

11004

Zucker Hillside Hospital, New York

90095

University of California, Los Angeles, Los Angeles

92093

University of California, San Diego, San Diego

94121

University of California, San Francisco School of Medicine, San Francisco

06519

Yale University, New Haven

02215

Harvard University/Beth Israel Deconess Medical Center, Boston

Unknown

University of Calgary, Calgary

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

University of California, Los Angeles

OTHER