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Early Family-Focused Treatment for Youth at Risk for Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00943085
Recruitment Status : Completed
First Posted : July 21, 2009
Last Update Posted : March 26, 2014
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David J. Miklowitz, Ph.D., University of California, Los Angeles

Brief Summary:
This study will test a family-based therapy aimed at preventing or reducing the symptoms of bipolar disorder in at-risk children.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Behavioral: Family-focused therapy Behavioral: Brief educational treatment Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
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.
Other Names:
  • FFT
  • Family Therapy
  • Psychoeducation
  • Psychosocial Intervention
  • Psychotherapy
  • Behavior Therapy

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.
Other Names:
  • Psychoeducation
  • Crisis Management
  • Enhanced Care
  • Diagnostic Evaluation

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Delayed onset of first manic, mixed, or hypomanic episode, measured on the A-LIFE [ Time Frame: Measured every 4 months for 1 year ]
  2. Scores on the Child Depression Rating Scale [ Time Frame: Measured every 4 months for 1 year ]
  3. Scores on the Young Mania Rating Scale [ Time Frame: Measured every 4 months for 1 year ]
  4. Parental mood and distress, as measured by the Beck Depression Inventory, Symptom Checklist [ Time Frame: Measured every 4 months for 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has at least one biological parent or stepparent with whom the child or adolescent participant lives and who is willing to participate in family treatment
  • Has a DSM-IV diagnosis of at least one of the following within the past 2 years : bipolar disorder not otherwise specified (BD-NOS), major depressive disorder (MDD), or cyclothymia
  • If the main diagnosis is MDD, the depressive episode must have occurred within the past 2 years
  • Has evidence of current significant affective symptoms, as determined by a score greater than 11 on the Young Mania Rating Scale within the last week or a score greater than 29 on the Child Depression Rating Scale-Revised within the last 2 weeks
  • Not currently enrolled in family or marital therapy
  • Has at least one biological parent or sibling with a verifiable diagnosis of bipolar disorder I or II
  • Speaks English

Exclusion Criteria:

  • Fully diagnosable bipolar disorder I or II
  • Diagnosis of autism or pervasive developmental disorder
  • Evidence of mental retardation, as defined by an intelligence quotient (IQ) less than 70
  • Presence of comorbid neurologic diseases such as seizure disorder
  • Substance or alcohol abuse or dependence disorders in the 4 months prior to study recruitment
  • Evidence of a life-threatening eating disorder or other medical disorder that requires emergency medical treatment
  • Has previously been treated with family-focused therapy
  • Evidence of current sexual or physical abuse or domestic abuse between the adult partners

Information from the National Library of Medicine

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 identifier (NCT number): NCT00943085

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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
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Mental Health (NIMH)
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Principal Investigator: David J. Miklowitz, PhD University of Colorado, Boulder

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David J. Miklowitz, Ph.D., Professor of Psychiatry, University of California, Los Angeles Identifier: NCT00943085    
Other Study ID Numbers: R34MH077856 ( U.S. NIH Grant/Contract )
R34MH077856 ( U.S. NIH Grant/Contract )
5R34MH077856 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2009    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014
Keywords provided by David J. Miklowitz, Ph.D., University of California, Los Angeles:
Early Signs of Bipolar Disorder
High Risk Youth
Additional relevant MeSH terms:
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Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders