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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. |
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| 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. |
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| 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 ] |
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| 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 ] |
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| Condition † | Bipolar Disorder Depression |
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| Intervention † | Behavioral: Interpersonal psychotherapy for prevention with adolescents Behavioral: Educational clinical monitoring |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 60 | ||||||||
| Start Date † | November 2006 | ||||||||
| Completion Date | November 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria for Parents:
Inclusion Criteria for Adolescents:
Exclusion Criteria for Parents:
Exclusion Criteria for Adolescents:
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| Gender | Both | ||||||||
| Ages | 12 Years to 17 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| 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 † |
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| 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 | ||||||||