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

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 2

Conditions: Psychotic Disorders; Mood Disorders

Treatments: Behavioral: Low Intensity Training; Behavioral: High Intensity Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02097563

5R33MH097007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: All

Ages: 13 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

133 participants in 2 patient groups

High Intensity Training

Experimental group

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;

Treatment:

Behavioral: High Intensity Training

Low Intensity Training

Active Comparator group

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.

Treatment:

Behavioral: Low Intensity Training