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



Status:Not yet recruiting
Conditions:Psychiatric, Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:13 - 25
Updated:4/2/2016
Start Date:June 2014
End Date:January 2017
Contact:David J. Miklowitz, Ph.D.
Email:dmiklowitz@mednet.ucla.edu
Phone:(310) 267-2659

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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.

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.

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.
We found this trial at
3
sites
Torrance, California 90502
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Torrance, CA
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Culver City, California 90230
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Culver City, CA
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Granada Hills, California 91344
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Granada Hills, CA
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