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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00338806
First received: June 16, 2006
Last updated: March 25, 2009
Last verified: March 2009

June 16, 2006
March 25, 2009
November 2006
November 2009   (final data collection date for 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 ]
  • Measured at Week 12 and Months 6, 12, and 18 post-treatment: Kiddie Sads-Present and Lifetime version (KSADS-PL)
  • Children’s Depression Rating Scale-Revised (CDRS-R)
  • Young Mania Rating Scale (YMRS)
  • Children’s Global Assessment Scale (C-GAS)
Complete list of historical versions of study NCT00338806 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Measured at Week 12 and Months 6, 12, and 18 post-treatment: Attitudes Toward Treatment Questionnaire
  • Emotion Regulation Checklist
  • Family Assessment Device
  • Family History Screen
  • Mood Disorder Questionnaire
  • Patient Health Questionnaire
  • Social Adjustment Scale - Self Report
  • Social Rhythm Metric Short Form
  • Treatment Credibility Scale
Not Provided
Not Provided
 
Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder
Prevention for Symptomatic Offspring of Bipolar Parents

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

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Bipolar Disorder
  • Depression
  • Behavioral: Interpersonal psychotherapy for prevention with adolescents
    Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.
    Other Name: IPT-PA
  • Behavioral: Educational clinical monitoring
    Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
    Other Name: ECM
  • Experimental: A.
    Participants will receive interpersonal psychotherapy for prevention with adolescents
    Intervention: Behavioral: Interpersonal psychotherapy for prevention with adolescents
  • Active Comparator: B.
    Participants will receive educational clinical monitoring
    Intervention: Behavioral: Educational clinical monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
November 2009
November 2009   (final data collection date for primary outcome measure)

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)
Both
12 Years to 17 Years
No
Contact: Helen Verdeli, PhD 212-543-5262 verdelih@childpsych.columbia.edu
Contact: Karen A. Shoum, MA 212-543-5262 ks446@columbia.edu
United States
 
NCT00338806
K23 MH071530, DDTR BK-TKAR
Yes
Helen Verdeli, PhD, Assistant Professor of Psychology, Teachers College, Columbia University
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Helen Verdeli, PhD New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP