Randomized Trial of Parent Training for Young Children With Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 12
- 主要终点
- Aberrant Behavior Checklist Irritability Subscale
研究概览
简要总结
The purpose of this 24 week study is to determine whether a new Parent Training program is effective in reducing disruptive behaviors in young children with pervasive developmental disorders.
详细描述
Pervasive Developmental Disorders (PDDs) are a group of conditions that includes Autistic Disorder, Asperger's disorder and so called Pervasive Developmental Disorder - Not Otherwise Specified. Children with PDD show delays in speech and language and reduced social interaction. Some children with PDD also have behavior problems, including defiance of rules, aggression, and tantrums. The purpose of this study is to evaluate a new Parent Training program designed to decrease these behavior problems and improve daily living skills.
Following confirmation of eligibility, participants will be randomly assigned to receive either Parent Training or a Psychoeducational Program. The Parent Training program involves specific suggestions about how to deal with behavior problems. The Psychoeducational program covers specific issues related to autism and parenting, including an co-occurring medical conditions and treatment options.
Parents will attend up to 13 one-on-one sessions with a trained therapist over a 24-week period. Participation in the study also involves 2 home visits and 6 monthly assessment visits. The purpose of the assessment visits is to evaluate the child's response to treatment. Evaluations will also be conducted at 3 and 6 months after completion of the study.
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
- 3 Years 至 7 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Autistic Disorder, Pervasive Developmental Disorder, Not Otherwise Specified, or Asperger's Disorder
- •Between ages 3 yrs 0 months and 6 yrs 11 months.
- •No planned changes in the intensity of current treatment(s)
- •Medication free or on stable medication
排除标准
- •Diagnosis of Rett's Disorder or Childhood Disintegrative Disorder
- •Participation in a structured parent training program in the past 2 years
- •Developmental age < 18 months (IQ < 35)
结局指标
主要结局
Aberrant Behavior Checklist Irritability Subscale
时间窗: Week 24
Home Situations Questionnaire
时间窗: Week 24
次要结局
- Vineland Adaptive Behavior Scales(Week 24)
- Clinical Global Impressions Improvement Scale(Week 24)
研究者
Denis Sukhodolsky
Assistant Professor
Yale University
