Early Family-Focused Treatment for Youth at Risk for Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT00943085|
Recruitment Status : Completed
First Posted : July 21, 2009
Last Update Posted : March 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Behavioral: Family-focused therapy Behavioral: Brief educational treatment||Not Applicable|
Early-onset bipolar disorder (BD) is a chronic, recurrent disorder that starts before age 18. In addition to the debilitating effects of BD, which include episodes of lethargic depression and exhausting mania, children and adolescents with BD often have co-occurring disorders, such as attention deficit hyperactivity disorder, conduct disorder, substance abuse disorders, and anxiety disorders. Early interventions may lead to better mental health by preventing BD from ever fully expressing itself. This study will test an early intervention for BD called family-focused treatment (FFT), which targets children and adolescents who are at risk for developing BD. FFT will include education about BD and training in communication strategies and problem-solving skills. It will focus on the family, because family environmental factors are related to the course and recurrence of BD. By reducing risk factors and teaching coping skills, FFT aims to prevent expression of BD, delay the onset or reduce the severity of manic episodes, and ensure that the first treatment received is appropriate.
Participation in this study will last 1 year and include three parts. In the first part, participating children and their families will complete research interviews and questionnaires about the child's mood, behavior, beliefs, and problems. Parent participants will also provide information on the family background of mood or anxiety problems. In the second part, participants will be randomly assigned to receive one of two treatments: FFT or brief educational treatment. Participants receiving FFT will complete 12 therapy sessions in which parents, children, and siblings learn how to cope with mood disorders, new ways to talk to each other, and strategies for solving family problems. FFT sessions will occur weekly for the first 8 weeks and then every other week for the next 8 weeks. Participants receiving brief educational treatment will complete diagnostic assessments and a 1-hour individualized feedback session, and they will be given a workbook about childhood mood disorders. A counselor will be available to all participants, in case of emergencies, for the full study year. All participants will also be provided with standard pharmacotherapy as needed. In the third part of the study, participants will complete follow-up assessments every 4 months for 1 year. Assessments will include interviews and questionnaires similar to those completed in the first part of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Family-Focused Therapy as Early Treatment for Youth at Risk for Bipolar Disorder|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2011|
Experimental: Family-focused therapy
Participants will receive family-focused therapy.
Behavioral: Family-focused therapy
12 therapy sessions involving the at-risk child or adolescent, parents, and available siblings. Therapy will include psychoeducation about mood disorders, communication enhancement training, and problem-solving skills training. Ongoing medication management from a study psychiatrist will be available.
Active Comparator: Brief educational treatment
Participants will receive one session of diagnostic feedback, recommendations for continued treatment, and crisis intervention as needed.
Behavioral: Brief educational treatment
Thorough diagnostic assessment by a study evaluator, separate evaluation by a child psychiatrist, feedback session with parents and child, and provision of reading materials pertinent to managing childhood mood disorders. Ongoing medication management and crisis-oriented family sessions will be available as needed.
- Changes in symptoms and functioning of at-risk children, as defined by depression and mania scores and psychiatric status on the Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE) [ Time Frame: Measured every 4 months for 1 year ]
- Delayed onset of first manic, mixed, or hypomanic episode, measured on the A-LIFE [ Time Frame: Measured every 4 months for 1 year ]
- Scores on the Child Depression Rating Scale [ Time Frame: Measured every 4 months for 1 year ]
- Scores on the Young Mania Rating Scale [ Time Frame: Measured every 4 months for 1 year ]
- Parental mood and distress, as measured by the Beck Depression Inventory, Symptom Checklist [ Time Frame: Measured every 4 months for 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943085
|United States, California|
|Stanford University School of Medicine, Lucile Packard Children's Hospital|
|Stanford, California, United States, 94304|
|United States, Colorado|
|University of Colorado, Boulder|
|Boulder, Colorado, United States, 80309-0345|
|Principal Investigator:||David J. Miklowitz, PhD||University of Colorado, Boulder|