Trial record 10 of 4440 for:    Open Studies | "Psychotic Disorders"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
David J. Miklowitz, Ph.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02097563
First received: March 24, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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 Intervention Phase
Mood Disorders
Psychotic Disorders
Behavioral: High Intensity Training
Behavioral: Low Intensity Training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family-Focused Therapy for Youth With Early-Onset Bipolar or Psychotic Disorders

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Therapist Competency and Adherence Rating [ Time Frame: One year ] [ Designated as safety issue: No ]
    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:
  • Patient Health Questionnaire, 9 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Self-rating of depression and impairment, administered at baseline, 4 months, and 12 months

  • Young Mania Rating Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Mania symptoms (based on observer report) at baseline, 4 months and 12 months


Estimated Enrollment: 80
Study Start Date: June 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   13 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02097563

Contacts
Contact: David J. Miklowitz, Ph.D. (310) 267-2659 dmiklowitz@mednet.ucla.edu
Contact: Brittany Matkevich (310) 825-2836 bmatkevich@mednet.ucla.edu

Locations
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    rgaba@didihirsch.org   
San Fernando Mental Health Center Not yet recruiting
Granada Hills, California, United States, 91344
Contact: Alex Kopelowicz, MD    818-832-2400    akopel@ucla.edu   
Harbor/UCLA Outpatient Psychiatry Porgram Not yet recruiting
Torrance, California, United States, 90502
Contact: Bowen Chung, MD    310-222-1801    bchung@mednet.ucla.edu   
Principal Investigator: Ira Lesser, MD         
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: David J. Miklowitz, Ph.D., Professor of Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02097563     History of Changes
Other Study ID Numbers: 5R33MH097007
Study First Received: March 24, 2014
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
Mood Disorders
Psychosis
Subthreshold
Bipolar Disorder

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Mood Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 19, 2014