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

Psychotic Disorders Clinical Trial

— FFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097563
• Other study ID #: 5R33MH097007
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2014
• Est. completion date: January 1, 2019

Study information

• Verified date: March 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: January 1, 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Mood Disorders
• Psychotic Disorders

Intervention

Behavioral:
• High Intensity Training
This is a training method involving a live workshop followed by high intensity technical consultation.
• Low Intensity Training
Clinicians complete an online workshop in family-focused therapy, followed by technical consultation sessions after every third session.

Locations

Country	Name	City	State
United States	Didi Hirsch Mental Health Services	Culver City	California
United States	San Fernando Mental Health Center	Granada Hills	California
United States	Harbor/UCLA Outpatient Psychiatry Porgram	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	One year
Secondary	Patient Health Questionnaire, 9	Self-rating of depression and impairment, administered at baseline, 4 months, and 12 months	1 year
Secondary	Young Mania Rating Scale	Mania symptoms (based on observer report) at baseline, 4 months and 12 months	1 year

External Links

•   UCLA Child and Adolescent Mood Disorders Program