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Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder
Official Title  Prevention for Symptomatic Offspring of Bipolar Parents
Brief Summary

This study will develop strategies for early detection and prevention of mood disorders and associated impairment in adolescent children of parents with bipolar disorder.

Detailed Description

Bipolar Disorder (BD) is a serious medical illness that causes drastic shifts in a person's mood, energy, and ability to function. BD symptoms alternate from increased energy, restlessness, and overly good mood to a lasting sad, anxious, or empty mood and feelings of hopelessness or pessimism. Research suggests that children of parents with BD are at risk for developing mood disorders because of predisposing genetic factors and stressful life events, many of which may be related to their parents' unstable clinical state. Adolescent children of parents with BD must deal simultaneously with the difficult task of negotiating their own developmental transitions, as well as living with a parent with BD. It may be possible to detect symptoms of BD or other mood disorders early in adolescence and prevent the disorder from further interfering with someone's life. This study will develop and refine strategies for early detection and primary prevention of mood disorders and associated impairment in adolescent children of parents with BD.

Participants in this single-blind study will be randomly assigned to receive either interpersonal psychotherapy with adolescents (IPT-PA) or a control intervention, educational clinical monitoring (ECM), for 12 weeks. Participants assigned to IPT-PA will attend twelve sessions. The first four sessions will last 90 minutes each, and will include both family psychoeducation and individual psychotherapy with the adolescent. The remaining sessions will be 45 minutes each, and will include only individual psychotherapy with the adolescent. Participants assigned to ECM will each be assigned to a therapist. During the initial two sessions, which will take place over 2 consecutive weeks, the therapist will focus on mood disorder psychoeducation and participants will receive related written educational material. Participants will then meet with their therapists monthly for 30-minute sessions. Symptoms and functioning will be assessed, but no assistance on building interpersonal skills will be provided. A participant may request a second session each month, but if more than two monthly sessions are required, the participant will be referred for therapy. Mood episodes and symptoms, symptom severity, and functioning will be assessed for all participants at Weeks 6 and 12 and Months 6, 12, and 18 post-treatment.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  K SADS-Present and Lifetime version (KSADS-PL) [ Time Frame: Measured at Week 12 and Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: Yes ]
Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: Measured at Week 12 and Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: Yes ]
Young Mania Rating Scale (YMRS) [ Time Frame: Measured at Week 12 and Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ]
Children's Global Assessment Scale (C-GAS) [ Time Frame: Measured at Week 12 and Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Attitudes Toward Treatment Questionnaire [ Time Frame: Measured at Week 12 and Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ]
Emotion Regulation Checklist [ Time Frame: Measured at Week 12 and Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ]
Family Assessment Device [ Time Frame: Measured at Week 12 and Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ]
Family history screen [ Time Frame: Measured at Week 12 and Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ]
Mood Disorder Questionnaire [ Time Frame: Measured at Week 12 and Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ]
Patient Health Questionnaire [ Time Frame: Measured at Week 12 and Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ]
Social Adjustment Scale - Self Report [ Time Frame: Measured at Week 12 and Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ]
Social Rhythm Metric Short Form [ Time Frame: Measured at Week 12 and Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ]
Treatment Credibility Scale [ Time Frame: Measured at Week 12 and Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ]
Condition  Bipolar Disorder
Depression
Intervention  Behavioral: Interpersonal psychotherapy for prevention with adolescents
Behavioral: Educational clinical monitoring
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  60
Start Date  November 2006
Completion Date November 2009
Eligibility Criteria 

Inclusion Criteria for Parents:

  • Diagnosis of BD I or II
  • Currently in partial or full remission from a depressive or manic episode
  • Under active clinical care

Inclusion Criteria for Adolescents:

  • Speaks English or Spanish
  • Presence of at least one current mood symptom meeting DSM-IV Criterion A and at least one depression or mania symptom meeting DSM-IV Criterion B
  • Depression, irritability, anhedonia, or elated mood scored at level 2 or 3 on the KSADS-PL
  • Mania symptom scored at level 2 or 3 on the KSADS-PL scale
  • Score of less than 40 on the CDRS-R scale
  • Score of less than 15 on the YMRS scale
  • Mild-moderate functional impairment, defined as a score of greater than 61 and less than 75 on the C-GAS scale

Exclusion Criteria for Parents:

  • History of psychosis within 1 month of study entry
  • At risk for suicide within 1 month of study entry

Exclusion Criteria for Adolescents:

  • Past major depressive or manic episode
  • Current or past psychosis
  • History of suicide attempts
  • Current substance use disorder
  • Use of psychotropic medications and other medications that might impact mood (e.g., steroids)
Gender Both
Ages 12 Years to 17 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Helen Verdeli, PhD     212-543-5262     verdelih@childpsych.columbia.edu    
Contact: Karen A. Shoum, MA     212-543-5262     ks446@columbia.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00338806
Organization ID K23 MH71530
Secondary IDs †† DDTR BK-TKAR
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Helen Verdeli, PhD     New York State Psychiatric Institute    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date February 2008
First Received Date  June 16, 2006
Last Updated Date February 29, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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