Clinical Trials Directory

Trials / Completed

CompletedNCT02097563

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
133 (actual)
Sponsor
University of California, Los Angeles · Academic / Other
Sex
All
Age
13 Years – 25 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALHigh Intensity TrainingThis is a training method involving a live workshop followed by high intensity technical consultation.
BEHAVIORALLow Intensity TrainingClinicians complete an online workshop in family-focused therapy, followed by technical consultation sessions after every third session.

Timeline

Start date
2014-06-01
Primary completion
2019-01-01
Completion
2019-01-01
First posted
2014-03-27
Last updated
2020-03-25

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02097563. Inclusion in this directory is not an endorsement.