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

NCT04338152 | Active Not Recruiting

• 2 other identifiers: 20-0021021R01MH123575-01
• Study Type: interventional
• Target: 220
• Locations: 2 countries
• Sites: 7

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 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

Prodromal Schizophrenia; Psychosis; Family; Psychotic Disorders; Prodromal Symptoms

Keywords

Family Therapy; Family Focused Therapy; Prodromal psychosis; Clinical High Risk

Outcome Measures

Primary Outcomes (1)

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

  The change from baseline to follow-up in Total Scale of Prodromal Symptoms (SOPS) Positive scores (sum of items 1 to 5) will be significantly greater in clinical high-risk patients assigned to FFT-CHR vs. EC. Total SOPS scores range from 0-30, with higher scores indicating more severe symptoms. In FFT-CHR (versus EC), rates of remission of prodromal symptoms will be higher and rates of conversion to psychosis will be lower over 18 months.

  0, 6, 12, and 18 months

Secondary Outcomes (7)

• Perceived Criticism Scale

  0, 6, 12, and 18 months

• Family Interactional Assessment Task

  0 and 6 months

• Appraisal of Family Interactions

  0, 6, 12, and 18 months

• Global Functioning: Social Scale; Global Functioning: Role Scale

  0, 6, 12, and 18 months

• Global Assessment of Functioning Scale from the Structured Interview for Psychosis-risk Syndromes

  0, 6, 12, and 18 months

Study Arms (2)

FFT-CHR

EXPERIMENTAL

Family-Focused Therapy for Clinical High-Risk Individuals

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

Enhanced Care

ACTIVE COMPARATOR

Enhanced Care Psychoeducation for Clinical High-Risk Individuals

Behavioral: Enhanced Care (EC)

Interventions

Enhanced Care (EC) BEHAVIORAL

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.

Enhanced Care

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

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.

FFT-CHR

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• University of California, Los Angeles: lead

Study Sites (7)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, San Diego

San Diego, California, 92093, United States

Location

University of California, San Francisco School of Medicine

San Francisco, California, 94121, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Harvard University/Beth Israel Deconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Zucker Hillside Hospital

New York, New York, 11004, United States

Location

University of Calgary

Calgary, Alberta, Canada

Location

Related Publications (8)

• Miklowitz DJ, Chung B. Family-Focused Therapy for Bipolar Disorder: Reflections on 30 Years of Research. Fam Process. 2016 Sep;55(3):483-99. doi: 10.1111/famp.12237. Epub 2016 Jul 29.

  PMID: 27471058 BACKGROUND

• Marvin SE, Miklowitz DJ, O'Brien MP, Cannon TD. Family-focused therapy for individuals at clinical high risk for psychosis: treatment fidelity within a multisite randomized trial. Early Interv Psychiatry. 2016 Apr;10(2):137-43. doi: 10.1111/eip.12144. Epub 2014 Apr 11.

  PMID: 24725329 BACKGROUND

• Miklowitz DJ, O'Brien MP, Schlosser DA, Addington J, Candan KA, Marshall C, Domingues I, Walsh BC, Zinberg JL, De Silva SD, Friedman-Yakoobian M, Cannon TD. Family-focused treatment for adolescents and young adults at high risk for psychosis: results of a randomized trial. J Am Acad Child Adolesc Psychiatry. 2014 Aug;53(8):848-58. doi: 10.1016/j.jaac.2014.04.020. Epub 2014 Jun 2.

  PMID: 25062592 BACKGROUND

• O'Brien MP, Miklowitz DJ, Candan KA, Marshall C, Domingues I, Walsh BC, Zinberg JL, De Silva SD, Woodberry KA, Cannon TD. A randomized trial of family focused therapy with populations at clinical high risk for psychosis: effects on interactional behavior. J Consult Clin Psychol. 2014 Feb;82(1):90-101. doi: 10.1037/a0034667. Epub 2013 Nov 4.

  PMID: 24188511 BACKGROUND

• O'Brien MP, Miklowitz DJ, Cannon TD. Decreases in perceived maternal criticism predict improvement in subthreshold psychotic symptoms in a randomized trial of family-focused therapy for individuals at clinical high risk for psychosis. J Fam Psychol. 2015 Dec;29(6):945-51. doi: 10.1037/fam0000123. Epub 2015 Jul 13.

  PMID: 26168262 BACKGROUND

• Salinger JM, O'Brien MP, Miklowitz DJ, Marvin SE, Cannon TD. Family communication with teens at clinical high-risk for psychosis or bipolar disorder. J Fam Psychol. 2018 Jun;32(4):507-516. doi: 10.1037/fam0000393. Epub 2018 Feb 1.

  PMID: 29389150 BACKGROUND

• O'Brien MP, Zinberg JL, Ho L, Rudd A, Kopelowicz A, Daley M, Bearden CE, Cannon TD. Family problem solving interactions and 6-month symptomatic and functional outcomes in youth at ultra-high risk for psychosis and with recent onset psychotic symptoms: a longitudinal study. Schizophr Res. 2009 Feb;107(2-3):198-205. doi: 10.1016/j.schres.2008.10.008. Epub 2008 Nov 8.

  PMID: 18996681 BACKGROUND

• Cornblatt BA, Auther AM, Niendam T, Smith CW, Zinberg J, Bearden CE, Cannon TD. Preliminary findings for two new measures of social and role functioning in the prodromal phase of schizophrenia. Schizophr Bull. 2007 May;33(3):688-702. doi: 10.1093/schbul/sbm029. Epub 2007 Apr 17.

  PMID: 17440198 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Prodromal Symptoms; Schizotypal Personality Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personality Disorders

Study Officials

• David J. Miklowitz, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Carrie E. Bearden, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Kristin S. Cadenhead, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Scott Woods, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

• Jean M. Addington, Ph.D.

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Michelle Friedman-Yakoobian, Ph.D.

  Harvard Medical School/Massachusetts Mental Health Center

  PRINCIPAL INVESTIGATOR

• Andrea M. Auther, Ph.D.

  Zucker Hillside Hospital at Hofstra / Northwell Health

  PRINCIPAL INVESTIGATOR

• Barbara A. Cornblatt, Ph.D., M.B.A.

  Hofstra University / Northwell Health

  PRINCIPAL INVESTIGATOR

• Daniel H. Mathalon, Ph.D., M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Holly K. Hamilton, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: FFT-CHR assists families with (1) recognizing the youth's psychosis risk symptoms and warning signs of escalating risk, (2) understanding vulnerability to psychosis and interventions, and (3) operating effectively as a unit. The manual includes session instructions and handouts. The Enhanced care (EC) condition has also been manualized and tested as a family educational treatment in CHR and bipolar youth. The 3 weekly sessions involve an abridged form of FFT-CHR psychoeducation. Then the youth has monthly individual sessions focused on applying the prevention plan and nondirective problem-solving of conflicts. The clinician serves as case manager. See further description below.

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 8, 2020
• Study Start: January 15, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year following end of study.
• Access Criteria: To be determined.

Locations

US (6); CA (1)