Mentalization-Based Therapy to Prevent Suicidal Behavior in Adolescents With Bipolar Disorder
1 other identifier
interventional
10
1 country
1
Brief Summary
Children and adolescents with early-onset bipolar disorder (BD) are at high risk for intentionally hurting themselves. Although there are therapies in existence for these youths with BD, they do not address suicide prevention specifically. Mentalization-based therapy for adolescents (MBT-A) has been shown to be helpful in reducing self-harm in the adolescent and adult population with borderline personality disorder. The investigators will modify the MBT-A treatment procedures for persons with BD who have had a recent period of suicidal ideation or behavior.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
1 active site
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
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 25, 2014
CompletedFirst Posted
Study publicly available on registry
May 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedApril 18, 2019
April 1, 2019
3.7 years
April 25, 2014
April 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-harm Scores
Self-harm is a composite score derived from two Kiddie Schedule for Affective Disorders and Schizophrenia Depression Rating Scale items, total scores on the Harkavy-Asnis Suicide Scale, total scores on the Risk and Self-Harm Scale, and specific levels of ideation or behavior on the Columbia Suicide and Self-Harm Scale.
measured every 3 months for 9 months
Secondary Outcomes (2)
Treatment completion
first 6 study months
Depression scores
every 3 months for 9 months
Study Arms (1)
Mentalization-Based Therapy
EXPERIMENTALUp to 21 individual MBT-A sessions plus 9 monthly family sessions. MBT-A will include psychoeducation and coping strategies.
Interventions
Up to 21 individual MBT-A sessions plus 9 monthly family sessions. MBT-A sessions will focus on the adolescent's recent social experiences and the resulting mental states and managing interpersonal challenges, particularly those involving separation or loss. The goal of this intervention is to improve the adolescent's ability to mentalize: to understand, acknowledge, and predict thoughts and feelings in oneself and others.
Eligibility Criteria
You may qualify if:
- Diagnosis of Bipolar Disorder I, Bipolar Disorder II, or Bipolar Disorder Not Otherwise Specified
- Living with or in close contact with at least one parent who is willing to participate
- Have had at least 1 week in the prior 3 months of significant suicidal ideation and/or at least one suicidal event in the 3 months prior to study intake.
- Willing to be treated pharmacologically by a psychiatrist in the UCLA Child and Adolescent Mood Disorders (CHAMP) clinic
You may not qualify if:
- Participants requiring immediate hospitalization
- Diagnosis of borderline personality disorder, schizophrenia, or schizoaffective disorder.
- Current substance dependence disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Los Angeles
Los Angeles, California, 90095, United States
Related Publications (2)
Miklowitz DJ, Taylor DO. Family-focused treatment of the suicidal bipolar patient. Bipolar Disord. 2006 Oct;8(5 Pt 2):640-51. doi: 10.1111/j.1399-5618.2006.00320.x.
PMID: 17042836BACKGROUNDRossouw TI, Fonagy P. Mentalization-based treatment for self-harm in adolescents: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2012 Dec;51(12):1304-1313.e3. doi: 10.1016/j.jaac.2012.09.018.
PMID: 23200287BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David J Miklowitz, Ph.D.
UCLA Department of Psychiatry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
April 25, 2014
First Posted
May 2, 2014
Study Start
January 1, 2014
Primary Completion
September 1, 2017
Study Completion
September 1, 2018
Last Updated
April 18, 2019
Record last verified: 2019-04