Prevention for Symptomatic Offspring of Bipolar Parents
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- New York State Psychiatric Institute
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Children's Depression Rating Scale-Revised (CDRS-R)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Children's Depression Rating Scale-Revised (CDRS-R)
Time Frame: 18 months
CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores \> 41 indicate mild-moderate depression.
Young Mania Rating Scale (YMRS)
Time Frame: 18 months
An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.
K SADS-Present Version (KSADS-P)
Time Frame: 18 months
A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.
Children's Global Assessment Scale (C-GAS)
Time Frame: 18 months
C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.
Secondary Outcomes
- Attitudes Toward Treatment Questionnaire(Measured at Week 12)
- Family History Screen(Measured at Week 1 (baseline))
- Patient Health Questionnaire(Measured at Week 1)
- Family Assessment Device(Measured at Week 12)
- Social Rhythm Metric Short Form(Measured at Week 12 and Months 6, 12, and 18 post-treatment)
- Social Adjustment Scale - Self Report for Adolescents(12 months and 18 months)
- Treatment Credibility Scale(Measured at Week 1)
- Emotion Regulation Questionnaire(12 months and 18 months)
- Mood Disorder Questionnaire(Week 1)