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

Primary Purpose

Mood Disorders, Psychotic Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
High Intensity Training
Low Intensity Training
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mood Disorders focused on measuring Mood Disorders, Psychosis, Subthreshold, Bipolar Disorder

Eligibility Criteria

13 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Didi Hirsch Mental Health Services
  • San Fernando Mental Health Center
  • Harbor/UCLA Outpatient Psychiatry Porgram

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Intensity Training

Low Intensity Training

Arm Description

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;

Low Intensity Training: clinician completes online workshop in FFT and then, after taking on a case, gets telephone consultation sessions after every third session.

Outcomes

Primary Outcome Measures

Therapist Competency and Adherence Rating
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
Self-rating of depression and impairment, administered at baseline, 4 months, and 12 months
Young Mania Rating Scale
Mania symptoms (based on observer report) at baseline, 4 months and 12 months

Full Information

First Posted
March 24, 2014
Last Updated
March 23, 2020
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02097563
Brief Title
Family-Focused Therapy for Youth With Early-Onset Bipolar or Psychotic Disorders
Acronym
FFT
Official Title
Family-Focused Therapy for Youth With Early-Onset Bipolar or Psychotic Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2014 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study aims to : 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); assess the cost of FFT training and implementation support; and 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders, Psychotic Disorders
Keywords
Mood Disorders, Psychosis, Subthreshold, Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Training
Arm Type
Experimental
Arm Description
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;
Arm Title
Low Intensity Training
Arm Type
Active Comparator
Arm Description
Low Intensity Training: clinician completes online workshop in FFT and then, after taking on a case, gets telephone consultation sessions after every third session.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Training
Intervention Description
This is a training method involving a live workshop followed by high intensity technical consultation.
Intervention Type
Behavioral
Intervention Name(s)
Low Intensity Training
Intervention Description
Clinicians complete an online workshop in family-focused therapy, followed by technical consultation sessions after every third session.
Primary Outcome Measure Information:
Title
Therapist Competency and Adherence Rating
Description
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)
Time Frame
One year
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire, 9
Description
Self-rating of depression and impairment, administered at baseline, 4 months, and 12 months
Time Frame
1 year
Title
Young Mania Rating Scale
Description
Mania symptoms (based on observer report) at baseline, 4 months and 12 months
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For patient participants: Youth (13-17 years of age) and young adults (18-25 years of age) with the following: Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of bipolar disorder (BD) type I or II; DSM-5 diagnosis of schizophrenia, schizophreniform disorder, or psychosis not otherwise specified [NOS]; DSM-5 diagnosis of bipolar disorder, not elsewhere classified (formerly bipolar NOS; see criteria below); or Research classification of ultra high-risk for psychosis. at least one parent or step-parent with whom the subject lives is willing to participate in family treatment sessions; 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: works at one of the participating agencies (Harbor/UCLA, San Fernando Mental Health Center, Didi Hirsch Mental Health Services) provides mental health care for youth or young adults with (or at risk for) bipolar or psychotic disorders 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: a DSM-5 diagnosis of autism or pervasive developmental disorder, by history or medical records; evidence of mental retardation by history or medical records (IQ < 70); 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; a life-threatening medical disorder that requires immediate hospitalization or other emergency treatment; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Miklowitz, Ph.D.
Organizational Affiliation
UCLA Semel Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bowen Chung, M.D.
Organizational Affiliation
Harbor/UCLA Outpatient Psychiatry Program
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ira Lesser, M.D.
Organizational Affiliation
Harbor/UCLA Outpatient Psychiatry Program
Official's Role
Study Director
Facility Information:
Facility Name
Didi Hirsch Mental Health Services
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
San Fernando Mental Health Center
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
Harbor/UCLA Outpatient Psychiatry Porgram
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23357439
Citation
Miklowitz DJ, Schneck CD, Singh MK, Taylor DO, George EL, Cosgrove VE, Howe ME, Dickinson LM, Garber J, Chang KD. Early intervention for symptomatic youth at risk for bipolar disorder: a randomized trial of family-focused therapy. J Am Acad Child Adolesc Psychiatry. 2013 Feb;52(2):121-31. doi: 10.1016/j.jaac.2012.10.007. Epub 2013 Jan 2.
Results Reference
background
PubMed Identifier
33779991
Citation
Miklowitz DJ, Weintraub MJ, Posta F, Denenny DM, Chung B. Effects of High- versus Low-Intensity Clinician Training on Implementation of Family-Focused Therapy for Youth with Mood and Psychotic Disorders. Fam Process. 2021 Sep;60(3):727-740. doi: 10.1111/famp.12646. Epub 2021 Mar 29.
Results Reference
derived
Links:
URL
http://www.semel.ucla.edu/champ
Description
UCLA Child and Adolescent Mood Disorders Program

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

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