跳至主要内容
临床试验/NCT00404911
NCT00404911已完成不适用

Family Groups to Reduce Youth Behavioral Difficulties

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 416 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
416
试验地点
1
主要终点
Youth externalizing behaviors and functioning

研究概览

简要总结

This study will examine the effectiveness of a multiple family group mental health service delivery strategy in improving mental health service use and outcome for urban, low income children of color, ages 7-11 years old with disruptive behaviors and their families.

详细描述

Oppositional defiant disorder (ODD) and conduct disorder (CD) are two common childhood psychiatric disorders. Children with ODD frequently have temper tantrums, argue excessively with adults, deliberately attempt to annoy or upset people, and blame others for their mistakes or behavior. Children with CD may exhibit aggression toward people and animals, destruction of property, deceitfulness, and rule breaking. The symptoms of these disorders can negatively affect children's social, family, and academic lives. Research has shown that early, comprehensive treatment leads to better treatment outcomes. Both disorders are commonly treated using parent training techniques. A multiple family group therapy setting may prove to be more engaging and beneficial than standard care for both parents and children. This study will examine the effectiveness of a multiple family group (MFG) mental health service delivery strategy in improving mental health service use and treatment outcome for urban, low income children of color with ODD or CD.

Participants in this 18-month, open-label study will be randomly assigned to either receive standard of care or participate in an MFG in addition to receiving standard of care. Participants assigned to standard of care will receive treatment that is traditionally offered to outpatients. Participants in an MFG will meet in their groups once a week for 16 weeks. Sessions will include adult caregivers and all children over age 6. Each session will follow the same procedures, and will proceed through the following stages: creating social networks; information exchange; group discussions; individual family practice; and homework assignment. Assessments of youth functioning will be held at Weeks 8 and 16 and Months 6 and 18 post-treatment.

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
None

入排标准

年龄范围
7 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Youth participants are between the ages of 7 and 11
  • Adult caregivers are available to participate in the research and intervention activities
  • Both youth and adult caregiver are English- or Spanish-speaking
  • Youth meets criteria for a primary diagnosis of oppositional defiant disorder or conduct disorder, as measured by the Disruptive Behavior Disorder Rating Scale (DBD)

排除标准

  • Youth has significant cognitive impairment that might interfere with understanding of program content or informed consent process
  • Youth or adult has emergency psychiatric needs that require services beyond those provided within an outpatient setting (e.g., hospitalization or specialized placement outside the home)
  • Youth who are wards of the state

结局指标

主要结局

Youth externalizing behaviors and functioning

时间窗: Measured 6 Months follow-up visit

次要结局

  • Parenting skills(16 weeks and 6 months)
  • Involvement in child mental health care(16 weeks and 6 months)
  • Parent/child interaction(16 weeks and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验