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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00050557 |
Purpose
The purpose of this study is to evaluate the effectiveness of a Multifamily Psychoeducation Group for the families of children with mood disorders.
| Condition | Intervention | Phase |
|---|---|---|
|
Mood Disorders |
Behavioral: Multifamily Psychoeducation Group (MFPG) Behavioral: Treatment as usual (TAU) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Family Psychoeducation: Efficacy in Child Mood Disorders |
| Enrollment: | 165 |
| Study Start Date: | July 2001 |
| Estimated Study Completion Date: | September 2008 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual
|
Behavioral: Multifamily Psychoeducation Group (MFPG)
MFPG will include 8 weekly 90-minute group therapy sessions.
Behavioral: Treatment as usual (TAU)
Participants will receive standard care for mood disorders.
|
|
2: Active Comparator
Participants will receive treatment as usual and waitlist Multi-Family Psychoeducation Group treatment
|
Behavioral: Multifamily Psychoeducation Group (MFPG)
MFPG will include 8 weekly 90-minute group therapy sessions.
Behavioral: Treatment as usual (TAU)
Participants will receive standard care for mood disorders.
|
Mood disorders among youth are a major health concern. Existing mood disorder studies focus on adults, and studies that focus on effective intervention strategies for youth with mood disorders are needed. This 8-session study is an adjunct to ongoing medication management and individual and family psychotherapy for children with mood disorders.
In this study, parents learn about mood disorders, their treatments, and how to work effectively with mental health and school systems. Parents also practice problem-solving and communication skills for symptom management. Children learn about mood disorders and their treatments, including basic cognitive-behavioral principles. Children also learn and practice anger management, problem-solving, and communication skills.
Patients and their families are randomly assigned to 1 of 2 groups. The first group receives 8 sessions of psychoeducation plus treatment as usual (TAU). The second group is a wait-list control in which participants receive only TAU. Patients and caregivers undergo a variety of interviews, tests, and behavioral observations throughout the study. Anxiety, depression, psychosocial stressors, manic symptoms, and children's experiences with psychotropic medications and with treatment or service providers are assessed. Caregivers, teachers, and family friends undergo interviews and make observations of the patient's level of support, general appearance and behavior, and overall functional capacity. The extent to which caregivers agree on the need for treatment and the extent of caregivers' knowledge of mood disorders is also assessed. Assessments occur at 3, 6, 12, 15, and 18 months after study enrollment. A comprehensive assessment is conducted at study entry and 1 year later.
Eligibility| Ages Eligible for Study: | 8 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Contacts and Locations
More Information
| Responsible Party: | The Ohio State University Research Foundation ( Mary A. Fristad, PhD ) |
| Study ID Numbers: | R01 MH61512, DSIR CT-S |
| Study First Received: | December 13, 2002 |
| Last Updated: | March 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00050557 History of Changes |
| Health Authority: | United States: Federal Government |
|
Pathologic Processes Disease Mental Disorders Mood Disorders |