Family Psychoeducation for Children With Mood Disorders

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of a Multifamily Psychoeducation Group for the families of children with mood disorders.

Detailed Description
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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.

Official Title
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Family Psychoeducation: Efficacy in Child Mood Disorders

Conditions
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Mood Disorders

Intervention / Treatment
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* Behavioral: Multifamily Psychoeducation Group (MFPG)
* Behavioral: Treatment as usual (TAU)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Major depressive disorder, dysthymic disorder, or bipolar disorder (Type I or II) IQ greater than 70 At least one parent/caregiver willing to participate in the study Able to attend six or more of the eight treatment sessions with at least 1 parent

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual | Behavioral: Multifamily Psychoeducation Group (MFPG)<br>* MFPG will include 8 weekly 90-minute group therapy sessions.<br>Behavioral: Treatment as usual (TAU)<br>* Participants will receive standard care for mood disorders.<br>|
| Active Comparator: 2<br>Participants will receive treatment as usual and waitlist Multi-Family Psychoeducation Group treatment | Behavioral: Multifamily Psychoeducation Group (MFPG)<br>* MFPG will include 8 weekly 90-minute group therapy sessions.<br>Behavioral: Treatment as usual (TAU)<br>* Participants will receive standard care for mood disorders.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood Severity Index |  | Measured at Months 6 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rage Index (MRS irritability + disruptive-aggressive items) |  | Measured at Months 6 and 12 |