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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00338806 |
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 |
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Bipolar Disorder Depression |
Behavioral: Interpersonal psychotherapy for prevention with adolescents Behavioral: Educational clinical monitoring |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prevention for Symptomatic Offspring of Bipolar Parents |
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 |
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A.: Experimental
Participants will receive interpersonal psychotherapy for prevention with adolescents
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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.
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B.: Active Comparator
Participants will receive educational clinical monitoring
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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.
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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.
Ages Eligible for Study: | 12 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for Parents:
Inclusion Criteria for Adolescents:
Exclusion Criteria for Parents:
Exclusion Criteria for Adolescents:
Contact: Helen Verdeli, PhD | 212-543-5262 | verdelih@childpsych.columbia.edu |
Contact: Karen A. Shoum, MA | 212-543-5262 | ks446@columbia.edu |
United States, New York | |
New York State Psychiatric Institute | Recruiting |
New York, New York, United States, 10032 |
Principal Investigator: | Helen Verdeli, PhD | New York State Psychiatric Institute |
Responsible Party: | Teachers College, Columbia University ( Helen Verdeli, PhD, Assistant Professor of Psychology ) |
Study ID Numbers: | K23 MH71530, DDTR BK-TKAR |
Study First Received: | June 16, 2006 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00338806 |
Health Authority: | United States: Federal Government |
Prevention Mood Disorders Unipolar Depression |
Affective Disorders, Psychotic Depression Mental Disorders Bipolar Disorder |
Mood Disorders Psychotic Disorders Depressive Disorder Behavioral Symptoms |
Pathologic Processes Disease |