Family-Focused Therapy for Youth With Early-Onset Bipolar or Psychotic Disorders (FFT)

March 23, 2020 updated by: David J. Miklowitz, Ph.D., University of California, Los Angeles

The present study aims to :

  1. compare different approaches (high intensity vs. low intensity) to training community providers (those who routinely treat young patients with bipolar disorder, psychosis, or sub-threshold high-risk conditions) on the implementation of family-focused treatment (FFT);
  2. assess the cost of FFT training and implementation support; and
  3. determine whether these different forms of clinician training are associated with different outcomes over 1 year among patients with early-onset mood and psychotic disorders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite impressive results in laboratory settings, there has been a significant lag in the community adoption and sustainability of family interventions for early-onset mood and psychotic disorders. Our objective is to determine the optimal methods of training and monitoring the delivery of an evidence-based family-focused treatment (FFT) in community providers who treat young patients (ages 13-25) with bipolar disorder (BD), psychosis, or "high-risk" conditions. FFT is administered in 12 sessions of psychoeducation, communication training, and problem-solving skills training. There are six randomized controlled trials indicating that, among adults or adolescents with BD, bipolar spectrum, or psychosis-risk disorders, FFT and pharmacotherapy are associated with more rapid stabilization of symptoms, delayed recurrences, enhanced functioning, better medication adherence, and improvements in family interaction relative to comparison treatments over 1-2 years. Using a community partnered participatory approach, we will engage diverse stakeholders (clinicians, administrators, caregivers) at three community sites (Harbor-UCLA Medical Center, San Fernando Mental Health Center, Didi Hirsch Mental Health Center) that treat early-onset, lower socioeconomic status, urban, and racially and ethnically diverse bipolar and psychosis patients. We will partner with these 3 community sites to randomly assign 30 clinicians to low intensity (web-based training plus low intensity supervision) or high intensity training (live workshop and higher intensity supervision, i.e., weekly individual supervision with fidelity feedback). Clinicians will administer FFT to up to 120 patients (ages 13-25) with recent-onset mania, psychosis or high-risk conditions. We expect that 20 clinicians will complete the treatment with 80 patients. Dependent variables will be empirically-derived fidelity component scores over time as measured by supervisors and clinicians. We hypothesize that after training, clinicians in both the high and low intensity groups will attain minimum levels of fidelity required for certification in the four components. However, clinicians in high intensity training will sustain higher levels of fidelity across subsequent treatment cases, and will be more satisfied and more likely to adopt the FFT model. This study will facilitate the translation of an evidence-based intervention and identify effective treatment components to inform larger-scale dissemination of FFT in community settings.

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Culver City, California, United States, 90230
        • Didi Hirsch Mental Health Services
      • Granada Hills, California, United States, 91344
        • San Fernando Mental Health Center
      • Torrance, California, United States, 90502
        • Harbor/UCLA Outpatient Psychiatry Porgram

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

For patient participants:

Youth (13-17 years of age) and young adults (18-25 years of age) with the following:

  1. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of bipolar disorder (BD) type I or II;
  2. DSM-5 diagnosis of schizophrenia, schizophreniform disorder, or psychosis not otherwise specified [NOS];
  3. DSM-5 diagnosis of bipolar disorder, not elsewhere classified (formerly bipolar NOS; see criteria below); or
  4. Research classification of ultra high-risk for psychosis.
  5. at least one parent or step-parent with whom the subject lives is willing to participate in family treatment sessions;
  6. the potential patient and relative(s) participants are able and willing to give written informed assent/consent to participate in the study.

Inclusion criteria for family clinicians:

  1. works at one of the participating agencies (Harbor/UCLA, San Fernando Mental Health Center, Didi Hirsch Mental Health Services)
  2. provides mental health care for youth or young adults with (or at risk for) bipolar or psychotic disorders
  3. are licensed (medical, psychologist, clinical social work, marriage and family therapy) mental health provider or are eligible to be a licensed mental health provider (social work / psychology intern or extern, psychiatry resident, psychiatry child and adolescent psychiatry fellow) in the State of California working under the direct supervision of a licensed mental health professional.

Exclusion Criteria for patients:

  1. a DSM-5 diagnosis of autism or pervasive developmental disorder, by history or medical records;
  2. evidence of mental retardation by history or medical records (IQ < 70);
  3. diagnosable and active substance or alcohol abuse or dependence disorders in the 4 months prior to study recruitment, although a lifetime history of substance or alcohol disorders can be present if the patient has been abstinent for at least 4 months;
  4. a life-threatening medical disorder that requires immediate hospitalization or other emergency treatment;
  5. evidence of current sexual or physical abuse of the child, and/or current domestic abuse between the adult partners. These situations usually require notification of the Department of Child Services and forms of treatment other than family therapy.

Exclusion criteria for clinicians: none.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Intensity Training
High intensity training: clinician attends a 6-hr live workshop in family-focused treatment techniques, and then, after taking on a case, gets weekly technical consultation sessions (by telephone) in FFT from an expert after every session;
Behavioral: High Intensity Training
This is a training method involving a live workshop followed by high intensity technical consultation.
Active Comparator: Low Intensity Training
Low Intensity Training: clinician completes online workshop in FFT and then, after taking on a case, gets telephone consultation sessions after every third session.
Behavioral: Low Intensity Training
Clinicians complete an online workshop in family-focused therapy, followed by technical consultation sessions after every third session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapist Competency and Adherence Rating
Time Frame: One year
This is a measure of how well the clinician administered family-focused treatment (FFT) based on ratings of audiotapes of family intervention sessions. These ratings are made every third session in both training conditions. This is an overall rating that can vary from 1 (nonadherent) to 7 (excellent adherence)
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire, 9
Time Frame: 1 year
Self-rating of depression and impairment, administered at baseline, 4 months, and 12 months
1 year
Young Mania Rating Scale
Time Frame: 1 year
Mania symptoms (based on observer report) at baseline, 4 months and 12 months
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: David J Miklowitz, Ph.D., UCLA Semel Institute
  • Study Director: Bowen Chung, M.D., Harbor/UCLA Outpatient Psychiatry Program
  • Study Director: Ira Lesser, M.D., Harbor/UCLA Outpatient Psychiatry Program

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R33MH097007 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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