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Clinical Trials/NCT00050557
NCT00050557
Completed
Phase 1

Family Psychoeducation: Efficacy in Child Mood Disorders

Mary Fristad1 site in 1 country165 target enrollmentJuly 2001
ConditionsMood Disorders

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Mood Disorders
Sponsor
Mary Fristad
Enrollment
165
Locations
1
Primary Endpoint
Mood Severity Index
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 2001
End Date
December 2006
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mary Fristad
Responsible Party
Sponsor Investigator
Principal Investigator

Mary Fristad

Professor, Psychiatry

Ohio State University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Mood Severity Index

Time Frame: Measured at Months 6 and 12

Secondary Outcomes

  • Rage Index (MRS irritability + disruptive-aggressive items)(Measured at Months 6 and 12)

Study Sites (1)

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