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
  Purpose

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


Condition Intervention Phase
Bipolar Disorder
Depression
Behavioral: Interpersonal psychotherapy for prevention with adolescents
Behavioral: Educational clinical monitoring
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention for Symptomatic Offspring of Bipolar Parents

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: November 2006
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A.
Participants will receive interpersonal psychotherapy for prevention with adolescents
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
Active Comparator: B.
Participants will receive educational clinical monitoring
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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338806

Contacts
Contact: Helen Verdeli, PhD 212-543-5262 verdelih@childpsych.columbia.edu
Contact: Karen A. Shoum, MA 212-543-5262 ks446@columbia.edu

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Investigators
Principal Investigator: Helen Verdeli, PhD New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: Helen Verdeli, PhD, Assistant Professor of Psychology, Teachers College, Columbia University
ClinicalTrials.gov Identifier: NCT00338806     History of Changes
Other Study ID Numbers: K23 MH071530, DDTR BK-TKAR
Study First Received: June 16, 2006
Last Updated: March 25, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Prevention
Mood Disorders
Unipolar Depression

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Mood Disorders
Affective Disorders, Psychotic
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 28, 2014