Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial
NCT ID: NCT04338152
Last Updated: 2026-01-26
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
220 participants
INTERVENTIONAL
2021-01-15
2026-12-31
Brief Summary
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Detailed Description
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Main Goals of FFT-CHR (Experimental Treatment)
1. To assist young clients and their family in: developing a common understanding of CHR symptoms; recognizing early signs of escalating symptoms; practicing individual and family coping strategies; and pre-planning family responses to any escalation in symptoms. When families have poor understanding of CHR symptoms and strategies for their management, this can fuel stressful home dynamics and contribute to youth withdrawal and decompensation.
2. For the youth and their family members to learn to express more constructive messages during their interactions, particularly regarding highly charged topics such as curbing risky behaviors and management of the offspring's symptoms.
3. For youth and family members to practice skills for resolving family or extrafamilial conflicts (usually those related to the youth's functioning) through effective communication and problem solving
The control condition, Enhanced Care (EC) shares the psychoeducation goal of FFT-CHR but is more oriented toward skill-training for the individual patient. Whereas it does not offer the same level of opportunity for families to build communication and problem-solving skills, the family is actively involved in helping the individual develop a relapse prevention plan. Monthly individual sessions focus on the development of individual coping skills such as symptom tracking and problem-solving. Both conditions require families to submit real-time mobile app surveys to assist with progress tracking.
Study Aims
The primary clinical outcomes are prodromal positive symptom scores examined immediately after treatment (6 months) and at 18 months. Secondary outcomes are time to remission of positive symptoms and psychosocial functioning over 18 months. Temporal relationships between early changes in treatment targets and later changes in symptoms or psychosocial functioning will also be examined.
Primary Hypotheses
1. FFT-CHR (vs. EC) will be associated with greater improvement in positive symptoms by end of therapy and follow-up (6 and 18 months), and greater high-risk syndrome remission and better psychosocial functioning at 18 months
2. FFT-CHR (vs. EC) will be associated with greater improvement in family communication and problem solving at 6 months
3. FFT-CHR (vs. EC) will be associated with greater improvement in youth-perceived parental criticism at 6 months. In turn, improvements in family communication, problem-solving and youths' perceptions of criticism will be associated with downstream improvements in the youths' primary outcomes (positive symptoms) and secondary outcomes (time to remission and psychosocial functioning) over 18 months. Thus, improvements in family functioning are hypothesized to mediate the relationship between treatment condition (FFT-CHR, EC) and changes in primary and secondary outcomes in the individual with CHR syndrome.
4. CHR individuals with higher baseline risk of conversion are hypothesized to improve more on family communication over 6 months and primary and secondary outcomes over 18 months in FFT-CHR than in EC.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
SINGLE
Study Groups
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FFT-CHR
Family-Focused Therapy for Clinical High-Risk Individuals
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.
Enhanced Care
Enhanced Care Psychoeducation for Clinical High-Risk Individuals
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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
2. Impaired intellectual functioning (IQ\<70)
3. Unwilling or unable to taper individual therapy to monthly by start of treatment
4. Past or current history of a clinically significant medical or central nervous system disorder that may contribute to CHR symptoms or confound assessment
5. 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.
13 Years
25 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of California, Los Angeles
OTHER
Responsible Party
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David J. Miklowitz, Ph.D.
Principal Investigator
Principal Investigators
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David J. Miklowitz, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Carrie E. Bearden, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Kristin S. Cadenhead, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Scott Woods, M.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University
Jean M. Addington, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Michelle Friedman-Yakoobian, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Harvard Medical School/Massachusetts Mental Health Center
Andrea M. Auther, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Zucker Hillside Hospital at Hofstra / Northwell Health
Barbara A. Cornblatt, Ph.D., M.B.A.
Role: PRINCIPAL_INVESTIGATOR
Hofstra University / Northwell Health
Daniel H. Mathalon, Ph.D., M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Holly K. Hamilton, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, Los Angeles
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
University of California, San Francisco School of Medicine
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Harvard University/Beth Israel Deconess Medical Center
Boston, Massachusetts, United States
Zucker Hillside Hospital
New York, New York, United States
University of Calgary
Calgary, Alberta, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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20-002102
Identifier Type: -
Identifier Source: org_study_id
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