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临床试验/NCT01012076
NCT01012076已完成不适用

Promoting Development in Toddlers With Communication Delays

Autism Speaks2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Autism Speaks
入组人数
60
试验地点
2
主要终点
Maternal Synchronization

研究概览

简要总结

Eighty parent-child dyads will be recruited and randomly assigned to either the experimental intervention or an active control condition. Subjects assigned to the experimental group will participate in 12 home-based intervention sessions.

详细描述

The experimental intervention is manualized, follows an illustrated workbook for parents, and uses individualized video-feedback, modeling, and coaching strategies to help parents establish play interactions that promote communication. All participants take part in comprehensive baseline and post-intervention/post-active control assessments, as well as 6- and 12-month follow up assessments. Families in the active control group will also be invited to participate in an oral feedback session to discuss the results from these assessments. Children's involvement in other forms of intervention will be monitored using a validated intervention log so that the moderating effects of these treatments can be examined.

By targeting parent-child interactions, the current intervention ensures that new child behaviors generalize beyond the immediate context of the intervention and are maintained over time (Schreibman, 2000). In addition, by involving parents in the treatment of their children (e.g., by establishing a daily playtime routine), the current intervention ensures that the intervention strategies are implemented with sufficient intensity for causing developmental change (National Research Council, 2001).

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
15 Months 至 30 Months(Child)
性别
All
接受健康志愿者

入选标准

  • The child is between 15 and 30 months of age;
  • The child scores at least one standard deviation below average on the Social Composite Score of the CSBS DP.

排除标准

  • The child has been diagnosed with a known medical condition that has been linked to either autism or mental retardation (e.g., Fragile X, Tuberous Sclerosis, Cerebral Palsy, Hydrocephalus).
  • The child has a severe visual, hearing, or motor impairment or fragile health condition that would prevent him/her from validly participating in the assessment procedures.

结局指标

主要结局

Maternal Synchronization

时间窗: 12 months

Maternal Synchronization will be measured at 12 month follow up of study.

次要结局

  • Early Social Communication Scale(12 months)

研究者

发起方
Autism Speaks
申办方类型
Other

研究点 (2)

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