Early Family-Focused Treatment for Youth at Risk for Bipolar Disorder
Family-Focused Therapy as Early Treatment for Youth at Risk for Bipolar Disorder
3 other identifiers
interventional
52
1 country
2
Brief Summary
This study will test a family-based therapy aimed at preventing or reducing the symptoms of bipolar disorder in at-risk children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2007
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 20, 2009
CompletedFirst Posted
Study publicly available on registry
July 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedMarch 26, 2014
March 1, 2014
3.3 years
July 20, 2009
March 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
Measured every 4 months for 1 year
Secondary Outcomes (4)
Delayed onset of first manic, mixed, or hypomanic episode, measured on the A-LIFE
Measured every 4 months for 1 year
Scores on the Child Depression Rating Scale
Measured every 4 months for 1 year
Scores on the Young Mania Rating Scale
Measured every 4 months for 1 year
Parental mood and distress, as measured by the Beck Depression Inventory, Symptom Checklist
Measured every 4 months for 1 year
Study Arms (2)
Family-focused therapy
EXPERIMENTALParticipants will receive family-focused therapy.
Brief educational treatment
ACTIVE COMPARATORParticipants will receive one session of diagnostic feedback, recommendations for continued treatment, and crisis intervention as needed.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Stanford University School of Medicine, Lucile Packard Children's Hospital
Stanford, California, 94304, United States
University of Colorado, Boulder
Boulder, Colorado, 80309-0345, United States
Related Publications (4)
Miklowitz DJ, Chang KD. Prevention of bipolar disorder in at-risk children: theoretical assumptions and empirical foundations. Dev Psychopathol. 2008 Summer;20(3):881-97. doi: 10.1017/S0954579408000424.
PMID: 18606036BACKGROUNDChang K, Howe M, Gallelli K, Miklowitz D. Prevention of pediatric bipolar disorder: integration of neurobiological and psychosocial processes. Ann N Y Acad Sci. 2006 Dec;1094:235-47. doi: 10.1196/annals.1376.026.
PMID: 17347355BACKGROUNDMiklowitz DJ, Schneck CD, Singh MK, Taylor DO, George EL, Cosgrove VE, Howe ME, Dickinson LM, Garber J, Chang KD. Early intervention for symptomatic youth at risk for bipolar disorder: a randomized trial of family-focused therapy. J Am Acad Child Adolesc Psychiatry. 2013 Feb;52(2):121-31. doi: 10.1016/j.jaac.2012.10.007. Epub 2013 Jan 2.
PMID: 23357439RESULTSchneck CD, Chang KD, Singh MK, DelBello MP, Miklowitz DJ. A Pharmacologic Algorithm for Youth Who Are at High Risk for Bipolar Disorder. J Child Adolesc Psychopharmacol. 2017 Nov;27(9):796-805. doi: 10.1089/cap.2017.0035. Epub 2017 Jul 21.
PMID: 28731778DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David J. Miklowitz, PhD
University of Colorado, Boulder
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
July 20, 2009
First Posted
July 21, 2009
Study Start
April 1, 2007
Primary Completion
August 1, 2010
Study Completion
August 1, 2011
Last Updated
March 26, 2014
Record last verified: 2014-03