Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder

NCT ID: NCT00338806

Last Updated: 2017-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2012-07-31

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.

Conditions

Bipolar Disorder; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Interpersonal Psychotherapy-Prevention

Participants will receive interpersonal psychotherapy for prevention with adolescents

Group Type: EXPERIMENTAL

Interpersonal psychotherapy for prevention with adolescents

Intervention Type: BEHAVIORAL

Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.

Educational and Clinical Monitoring

Participants will receive educational clinical monitoring

Group Type: ACTIVE_COMPARATOR

Educational clinical monitoring

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

IPT-PA; ECM

Eligibility Criteria

Inclusion Criteria

• Diagnosis of BD I or II
• Currently in partial or full remission from a depressive or manic episode
• Under active clinical care

• 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

• History of psychosis within 1 month of study entry
• At risk for suicide within 1 month of study entry

• 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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helen Verdeli, PhD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Other Identifiers

K23MH071530

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#5067

Identifier Type: -

Identifier Source: org_study_id