Clinical trial NCT02097563: Family-Focused Therapy for Youth With Early-Onset Bipolar or Psychotic Disorders
Official title: Family-Focused Therapy for Youth With Early-Onset Bipolar or Psychotic Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mood Disorders
Psychotic Disorders
Keywords: Mood Disorders
Psychosis
Subthreshold
Bipolar Disorder
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 133
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Therapist Competency and Adherence Rating
timeFrame: One year
Secondary outcomes:
measure: Patient Health Questionnaire, 9
timeFrame: 1 year
measure: Young Mania Rating Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Didi Hirsch Mental Health Services
state: California
city: Granada Hills
country: United States
facility: San Fernando Mental Health Center
state: California
city: Torrance
country: United States
facility: Harbor/UCLA Outpatient Psychiatry Porgram
state: California
Study officials:
affiliation: UCLA Semel Institute
name: David J Miklowitz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Harbor/UCLA Outpatient Psychiatry Program
name: Bowen Chung, M.D.
role: STUDY_DIRECTOR
affiliation: Harbor/UCLA Outpatient Psychiatry Program
name: Ira Lesser, M.D.
role: STUDY_DIRECTOR
References:
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.
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.