Multisite Study: Acquisition of Social Skills in Children With Autism Using Video Modeling in Parental Training
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Acquisition from baseline of new behaviors at 8 weeks
研究概览
简要总结
This is a Brazilian multisite study to test the efficacy of an Applied Behavior Analysis (ABA) parent training using video modeling to teach parents of children with Autism techniques to apply to their children in order to improve eye contact and joint attention behaviors.
Our hypothesis is that children with Autism whose parents will be trained by videomodeling will have better eye contact and joint attention behaviors compared to children with Autism whose parents will not be trained.
详细描述
Applied Behavior Analysis (ABA) is an intervention with proven efficacy in treating impairments on social functioning and daily-life activities of individuals with Autism Spectrum Disorder (ASD). In Brazil we have a limited number of qualified professionals and an increasing demand of families non-served in the public health system.
Our main objective is to standardize and test the efficacy of a model for parent training using video modeling for teaching eye contact and joint attention behaviors in children with ASD. These two behaviors are essential to develop adequate social interaction, the core impaired domain in ASD. It is a multisite study to be carried out at the Universidade Federal de São Paulo, Universidade de São Paulo and Universidade Presbiteriana Mackenzie. The sample will be composed of 70 children divided in control and intervention groups that will be randomly chosen. The intervention should be carried out in 21 weeks.
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
- •Clinical Diagnosis of Autism Spectrum Disorders
- •Diagnosis of Autism Spectrum Disorders by means of ADI
- •IQ equal or lower than 70 by means of SON
- •Main caregiver's level of education > primary education
排除标准
- •IQ lower than 50 by means of SON
- •Child who is receiving ABA therapy at least 10 hours per week
- •Main caregiver diagnosed with Autism Spectrum Disorders
结局指标
主要结局
Acquisition from baseline of new behaviors at 8 weeks
时间窗: baseline assessment to 8 weeks of therapy
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
Acquisition from baseline of new behaviors at 16 weeks
时间窗: baseline assessment to 16 weeks
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
Acquisition from baseline of new behaviors at 21 weeks
时间窗: baseline to 21 weeks
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
次要结局
- Change from baseline in Zaritt Burden Interview at 21 weeks(baseline assessment to 21 weeks)
- Change from baseline in Vineland Scale at 21 weeks(baseline assessment to 21 weeks)
- Change from baseline in Eye-tracking at 21 weeks(baseline assessment to 21 weeks)
- Change from baseline in SON-R 2½-7 at 21 weeks(baseline assessment to 21 weeks)
- Change from baseline in OERA at 21 weeks(baseline assessment to 21 weeks)
研究者
Jair Mari
MD, PhD
Federal University of São Paulo