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临床试验/NCT00050557
NCT00050557已完成1 期

Family Psychoeducation: Efficacy in Child Mood Disorders

Mary Fristad2 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2001年7月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
165
试验地点
2
主要终点
Mood Severity Index

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Mood Severity Index

时间窗: Measured at Months 6 and 12

次要结局

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

研究者

发起方
Mary Fristad
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mary Fristad

Professor, Psychiatry

Ohio State University

研究点 (2)

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