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临床试验/NCT01591707
NCT01591707已完成不适用

Evaluating a Social and Communication Intervention for Preschoolers

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.3 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2012年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
700
试验地点
3
主要终点
Change in educator instruction to meet fidelity of intervention.

研究概览

简要总结

The purpose of this study is to test the effectiveness of a school-based treatment aimed at increasing language and social skills in preschool-aged children with autism spectrum disorder (ASD). Through interactive development (continually seeking educator feedback for intervention improvement) and implementation of the intervention, the investigators hope to provide a feasible and practical means for educators to work with children with ASD in real world, large scale settings. ASD preschool educators, the children enrolled in their classes, between the ages of 3 and 6 years and their families may join.

详细描述

In Phase 4, KKI staff trained Delaware preschool teachers to serve as model coaches and educators through the Delaware Autism Program. Families whose children were enrolled in participating classrooms were consented through DAP using the school's consent to be videotaped. Any families who did not consent for their child to be videotaped for this training received the nonparticipant consent form currently utilized in this study and staff videotaping took every effort to keep those children out of frame when taping. This cohort involved KKI study team members training 1-2 coaches, who then trained five Delaware school teachers. The IES model was implemented in the teacher's classrooms (n= 5-10 students participating in each classroom; 20-40 children total).

In the current phase of the study, Phase 5 and 6, KKI study team members will continue the evaluation of the IES model, by testing the efficacy of the intervention model in a larger sample (Phase 5) and then analyzing the corresponding data (Phase 6). The larger efficacy study (phase 5) will be conducted on teachers and students recruited from public school districts in Maryland, Delaware, and Pennsylvania using the same IES model and recruitment methods in the previous phases.

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 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • For Teachers:
  • - Work in an ASD preschool classroom within a cooperating Baltimore County Public School.
  • For Children:
  • Meet Autism Diagnostic Observation Schedule-Generic (ADOS; Lord et al., 2002) and expert clinical judgment criteria for ASD
  • Have an IQ or Developmental Quotient of at least 40 based on the Early Learning Composite from the Mullen Scales of Early Learning (Mullen, 1995)
  • Be enrolled in a participating Baltimore County Public School ASD preschool classroom
  • Be between the ages of 3 and 6 and enrolled in a participating ASD preschool classroom.

排除标准

  • Children and educators may be taken out of the study if they:
  • Are unable to comply with the study protocol
  • Change schools due to relocation
  • Children may also be taken out of this study if they:
  • Sustain a head injury or other serious physical injury during the study
  • Are not being brought in for testing as designated in the protocol

结局指标

主要结局

Change in educator instruction to meet fidelity of intervention.

时间窗: approximately 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks into the intervention

Fidelity will be monitored throughout the duration of the intervention by KKI staff to assess the quality and consistency with which educators implement the intervention.

次要结局

  • Change in Baseline Mullen Scales of Early Learning(9 months into treatment)
  • Change in Child's Baseline Spontaneous Imitation Task(9 months into treatment)
  • Change in Child Classroom-based Social Communication Performance(9 months into treatment)
  • Change in Baseline Autism Diagnostic Observation Schedule(9 months into treatment)
  • Change in parent perception of child behavior as recorded by the Autism Composite score of the PDDBI (parent version)(9 months into treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Landa

Principal Investigator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

研究点 (3)

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