Psychotic DisordersNCT04338152
Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial
A study testing Family Focused Therapy for Clinical High Risk Youth (FFT-CHR) and Enhanced Care (EC) in people with Psychotic Disorders and Prodromal Symptoms, run by University of California, Los Angeles at 7 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Psychotic Disorders, Prodromal Symptoms, Prodromal Schizophrenia
- What is being tested?
- Family Focused Therapy for Clinical High Risk Youth (FFT-CHR) and Enhanced Care (EC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 15 Jan 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Harvard University/Beth Israel Deconess Medical Center
Boston, Massachusetts, 02215
University of California, Los Angeles
Los Angeles, California, 90095
Yale University
New Haven, Connecticut, 06519
Zucker Hillside Hospital
New York, New York, 11004
University of California, San Diego
San Diego, California, 92093
University of California, San Francisco School of Medicine
San Francisco, California, 94121
About this study
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.
Read the detailed description
This randomized, single blind trial will compare outcomes from a 6-month FFT-CHR intervention and a control condition (enhanced care, or EC) matched to the FFT-CHR in duration (6 months) and access to a clinician. Participants families in FFT-CHR are provided 18 family sessions augmented by a therapy app with content and surveys, while participants in the EC condition are provided three family sessions plus five monthly individual support and case management sessions. Duration of therapy sessions is one hour.
Main Goals of FFT-CHR (Experimental Treatment)
- 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.
- 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.
- 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
- 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
- FFT-CHR (vs. EC) will be associated with greater improvement in family communication and problem solving at 6 months
- 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.
- 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.
- Being tested
- Family Focused Therapy for Clinical High Risk Youth (FFT-CHR), Enhanced Care (EC)
- Keywords
- Family Therapy, Family Focused Therapy, Prodromal psychosis, Clinical High Risk
- Medical subject headings
- Psychotic Disorders, Prodromal Symptoms, Schizotypal Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Focused Therapy for Clinical High Risk Youth (FFT-CHR)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| FFT-CHR | Experimental | Family-Focused Therapy for Clinical High-Risk Individuals Receives: Behavioral: Family Focused Therapy for Clinical High Risk Youth (FFT-CHR) |
| Enhanced Care | Active comparator | Enhanced Care Psychoeducation for Clinical High-Risk Individuals Receives: Behavioral: Enhanced Care (EC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 6, 12, and 18 months
Secondary outcomes (7)
Perceived Criticism Scale
Measures adolescent perceived criticism from parent(s) during treatment (highest sum score for two items rated 1-10 each, with higher scores indicating more perceived criticism), as well as parental self-rated criticism of their child (highest sum score for either parent for the 2 items rated 1-10)
Measured: 0, 6, 12, and 18 months
Family Interactional Assessment Task
Measures proportion of constructive vs. conflictual parent/offspring and offspring/parent communication. Scores are derived from a 10-minute live interaction sample and transcript, with each speaking turn rated on communication dimensions. Proportional scores range from 0 - 1.0, with higher scores indicating a greater proportion of conflictual (or constructive) communication
Measured: 0 and 6 months
Appraisal of Family Interactions
Perceived frequency of constructive/calm and critical/conflictual interactions in each parent/offspring pairing. Sum of 5 items (1-10 scales) filled out by parent(s)/youth about the frequency of critical-conflictual and calm-constructive interactions and the level of distress experienced in these interactions, with higher scores indicating more of the behavior (conflict, constructive communication or distress)
Measured: 0, 6, 12, and 18 months
Global Functioning: Social Scale; Global Functioning: Role Scale
Independent evaluator rated social functioning and school/job functioning scales based on set interview questions and assessment data. Both scales capture level of functioning for the recent month, rated from 1-10, with higher scores indicating better functioning.
Measured: 0, 6, 12, and 18 months
Global Assessment of Functioning Scale from the Structured Interview for Psychosis-risk Syndromes
Independent evaluator rating of combined symptom and psychosocial functioning. 1-100 point scale captures current functioning and highest/lowest functioning since previous assessment point. Higher scores indicate better functioning.
Measured: 0, 6, 12, and 18 months
Calgary Depression Scale for Schizophrenia
Depression severity score based on 9-item evaluator interview (0-3 severity scores for each item). Combined total depression score, where higher scores indicate more depression.
Measured: 0, 6, 12, and 18 months
The Alcohol and Drug Use Scale
Independent evaluator rating of frequency of use and level of impairment from alcohol and substance use in the recent month, based on combined youth and parent reports. Higher scores indicate more substance or alcohol use.
Measured: 0, 6, 12, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start15 Jan 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David J. Miklowitz, Ph.D., University of California, Los Angeles
- Investigators
- David J. Miklowitz, Ph.D., Principal investigator, University of California, Los AngelesCarrie E. Bearden, Ph.D., Principal investigator, University of California, Los AngelesKristin S. Cadenhead, M.D., Principal investigator, University of California, San DiegoScott Woods, M.D., Principal investigator, Yale UniversityJean M. Addington, Ph.D., Principal investigator, University of CalgaryMichelle Friedman-Yakoobian, Ph.D., Principal investigator, Harvard Medical School/Massachusetts Mental Health CenterAndrea M. Auther, Ph.D., Principal investigator, Zucker Hillside Hospital at Hofstra / Northwell HealthBarbara A. Cornblatt, Ph.D., M.B.A., Principal investigator, Hofstra University / Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338152
- Sponsor's protocol ID
- 20-002102
- Other IDs
- 1R01MH123575-01
- Status last verified
- Jan 2026
- First submitted
- 3 Apr 2020
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completing the study we will submit a CD-ROM to the NIH Freedom of Information Act Coordinator containing all raw data, variable coding information, copies of measures, study protocol, and consent/assent forms. We will share the data with other investigators through the National Database for Clinical Trials Related to Mental Illness, using a Global Unique Identifier for each subject and Data Dictionary technology. Data descriptives (i.e., means, SDs) will be submitted every 6 months, with the full dataset submitted at the end of the four-year grant period.
Publications
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.
PubMed 27471058Marvin 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.
PubMed 24725329Miklowitz 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.
PubMed 25062592O'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.
PubMed 24188511O'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.
PubMed 26168262Salinger 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.
PubMed 29389150O'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.
PubMed 18996681Cornblatt 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.
PubMed 17440198
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial
- ClinicalTrials.gov ID
- NCT04338152
- Acronym / sponsor ID
- 20-002102
- Keywords
- Family Therapy, Family Focused Therapy, Prodromal psychosis, Clinical High Risk
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized, single blind trial will compare outcomes from a 6-month FFT-CHR intervention and a control condition (enhanced care, or EC) matched to the FFT-CHR in duration (6 months) and access to a clinician. Participants families in FFT-CHR are provided 18 family sessions augmented by a therapy app with content and surveys, while participants in the EC condition are provided three family sessions plus five monthly individual support and case management sessions. Duration of therapy sessions is one hour.
Main Goals of FFT-CHR (Experimental Treatment)
- 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.
- 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.
- 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
- 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
- FFT-CHR (vs. EC) will be associated with greater improvement in family communication and problem solving at 6 months
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| FFT-CHR | Experimental | Behavioral: Family Focused Therapy for Clinical High Risk Youth (FFT-CHR)Family-Focused Therapy for Clinical High-Risk Individuals |
| Enhanced Care | Active comparator | Behavioral: Enhanced Care (EC)Enhanced Care Psychoeducation for Clinical High-Risk Individuals |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | FFT-CHR |
| 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. | Behavioural | Enhanced Care |
Primary outcome
The Structured Interview for Psychosis-risk Syndromes Scale of Prodromal Symptoms (SOPS)
Time frame: 0, 6, 12, and 18 months
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.
7 secondary outcomes
Perceived Criticism Scale
Time frame: 0, 6, 12, and 18 months
Family Interactional Assessment Task
Time frame: 0 and 6 months
Appraisal of Family Interactions
Time frame: 0, 6, 12, and 18 months
Global Functioning: Social Scale; Global Functioning: Role Scale
Time frame: 0, 6, 12, and 18 months
Global Assessment of Functioning Scale from the Structured Interview for Psychosis-risk Syndromes
Time frame: 0, 6, 12, and 18 months
Calgary Depression Scale for Schizophrenia
Time frame: 0, 6, 12, and 18 months
The Alcohol and Drug Use Scale
Time frame: 0, 6, 12, and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 27471058Miklowitz 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.
- Background: PubMed 24725329Marvin 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.
- Background: PubMed 25062592Miklowitz 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.
- Background: PubMed 24188511O'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.
- Background: PubMed 26168262O'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.
- Background: PubMed 29389150Salinger 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.
- Background: PubMed 18996681O'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.
- Background: PubMed 17440198Cornblatt 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.
- Individual participant dataSharing planned: Yes. Upon completing the study we will submit a CD-ROM to the NIH Freedom of Information Act Coordinator containing all raw data, variable coding information, copies of measures, study protocol, and consent/assent forms. We will share the data with other investigators through the National Database for Clinical Trials Related to Mental Illness, using a Global Unique Identifier for each subject and Data Dictionary technology. Data descriptives (i.e., means, SDs) will be submitted every 6 months, with the full dataset submitted at the end of the four-year grant period.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J. Miklowitz, Ph.D. principal investigator
University of California, Los Angeles
Carrie E. Bearden, Ph.D. principal investigator
University of California, Los Angeles
Kristin S. Cadenhead, M.D. principal investigator
University of California, San Diego
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Focused Therapy for Clinical High Risk Youth (FFT-CHR) and Enhanced Care (EC) in people with Psychotic Disorders and Prodromal Symptoms, run by University of California, Los Angeles at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Structured Interview for Psychosis-risk Syndromes Scale of Prodromal Symptoms (SOPS) (time frame: 0, 6, 12, and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04338152, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.