Mood Disorders Clinical Trial
Official title:
Family Psychoeducation: Efficacy in Child Mood Disorders
The purpose of this study is to evaluate the effectiveness of a Multifamily Psychoeducation Group for the families of children with 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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