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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02097563
Recruitment Status : Unknown
Verified March 2014 by David J. Miklowitz, Ph.D., University of California, Los Angeles.
Recruitment status was:  Not yet recruiting
First Posted : March 27, 2014
Last Update Posted : March 27, 2014
Information provided by (Responsible Party):
David J. Miklowitz, Ph.D., University of California, Los Angeles

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Mood Disorders Psychotic Disorders Behavioral: High Intensity Training Behavioral: Low Intensity Training Phase 2

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family-Focused Therapy for Youth With Early-Onset Bipolar or Psychotic Disorders
Study Start Date : June 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Patient Health Questionnaire, 9 [ Time Frame: 1 year ]
    Self-rating of depression and impairment, administered at baseline, 4 months, and 12 months

  2. Young Mania Rating Scale [ Time Frame: 1 year ]
    Mania symptoms (based on observer report) at baseline, 4 months and 12 months

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Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02097563

Contact: David J. Miklowitz, Ph.D. (310) 267-2659
Contact: Brittany Matkevich (310) 825-2836

United States, California
Didi Hirsch Mental Health Services Not yet recruiting
Culver City, California, United States, 90230
Contact: Rebecca Gaba, Ph.D.    310-751-5353   
San Fernando Mental Health Center Not yet recruiting
Granada Hills, California, United States, 91344
Contact: Alex Kopelowicz, MD    818-832-2400   
Harbor/UCLA Outpatient Psychiatry Porgram Not yet recruiting
Torrance, California, United States, 90502
Contact: Bowen Chung, MD    310-222-1801   
Principal Investigator: Ira Lesser, MD         
Sponsors and Collaborators
University of California, Los Angeles
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

Additional Information:
Responsible Party: David J. Miklowitz, Ph.D., Professor of Psychiatry, University of California, Los Angeles Identifier: NCT02097563     History of Changes
Other Study ID Numbers: 5R33MH097007 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: March 2014

Keywords provided by David J. Miklowitz, Ph.D., University of California, Los Angeles:
Mood Disorders
Bipolar Disorder

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Mood Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders