Clinical trial NCT00338806: Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder
Official title: Prevention for Symptomatic Offspring of Bipolar Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Depression
Keywords: Prevention
Mood Disorders
Unipolar Depression
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-06-20
Enrollment: 7
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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)

Primary outcomes:
measure: K SADS-Present Version (KSADS-P)
timeFrame: 12 weeks
measure: K SADS-Present Version (KSADS-P)
timeFrame: 6 months
measure: K SADS-Present Version (KSADS-P)
timeFrame: 12 months
measure: K SADS-Present Version (KSADS-P)
timeFrame: 18 months
measure: Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: Week 12
measure: Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: 6 months
measure: Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: 12 months
measure: Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: 18 months
measure: Children's Global Assessment Scale (C-GAS)
timeFrame: Week 12
measure: Children's Global Assessment Scale (C-GAS)
timeFrame: 6 months
measure: Children's Global Assessment Scale (C-GAS)
timeFrame: 12 months
measure: Children's Global Assessment Scale (C-GAS)
timeFrame: 18 months
measure: Young Mania Rating Scale (YMRS)
timeFrame: Week 12
measure: Young Mania Rating Scale (YMRS)
timeFrame: 6 months
measure: Young Mania Rating Scale (YMRS)
timeFrame: 12 months
measure: Young Mania Rating Scale (YMRS)
timeFrame: 18 months
Secondary outcomes:
measure: Attitudes Toward Treatment Questionnaire
timeFrame: Measured at Week 12
measure: Emotion Regulation Questionnaire
timeFrame: Measured at Week 12
measure: Emotion Regulation Questionnaire
timeFrame: 6 months
measure: Emotion Regulation Questionnaire
timeFrame: 12 months and 18 months
measure: Family Assessment Device
timeFrame: Measured at Week 12
measure: Family History Screen
timeFrame: Measured at Week 1 (baseline)
measure: Mood Disorder Questionnaire
timeFrame: Week 1
measure: Patient Health Questionnaire
timeFrame: Measured at Week 1
measure: Social Adjustment Scale - Self Report for Adolescents
timeFrame: Measured at Week 12
measure: Social Adjustment Scale - Self Report for Adolescents
timeFrame: 12 months and 18 months
measure: Social Rhythm Metric Short Form
timeFrame: Measured at Week 12 and Months 6, 12, and 18 post-treatment
measure: Treatment Credibility Scale
timeFrame: Measured at Week 1
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Helen Verdeli, PhD
role: PRINCIPAL_INVESTIGATOR
References: