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临床试验/NCT00953095
NCT00953095已完成不适用

Optimizing Social and Communication Outcomes for Young Children With Autism

Health Resources and Services Administration (HRSA)10 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2009年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
112
试验地点
10
主要终点
Early Social Communication Scale

研究概览

简要总结

The goal of this project is to test an intervention program for caregivers and their young children with autism that is focused on improving social communication. This study specifically targets underserved populations, specifically children from low SES and racial/ethnic minority families. Participants will include 40 children (aged 24 months to 60 months) and their caregivers who will be randomized (as if by flipping a coin) to one of the two treatments: Parent education sessions for two hours a week for 12 weeks or parent-child intervention sessions with the child for one hour, twice a week for 12 weeks. Young children with autism have difficulty with engaging in joint attention with others (e.g. pointing, showing. Joint attention skills are important to later development of language. Therefore, targeting this problem in young children may result in better language outcomes for these children.

In order to examine the effects of the interventions, all participants will be complete cognitive, language, communication and play-based assessments prior to treatment, at the end of the first 12 weeks of the intervention, and post-treatment immediately following the intervention (approximately 2.5 to 3 hours each).

详细描述

Child/parent dyads will be randomized to one of two intervention conditions: (1) Parent-child model, also known as the Caregiver Education Model (CMM):focuses on joint attention/engagement intervention using an established evidence based treatment (Kasari et al., 2006). It involves individual interventionist meetings with the parents and their children in their homes for one hour, twice a week for 12 weeks. In this intervention, the parent-child pair meet with the interventionist (as opposed to the group training in the CEM condition). Parents will be specifically taught techniques for altering the home environment and ways to enhance children's language, social, and play development. Parents will given guided practice (input and coaching from the interventionist) as they implement these techniques with their child. (2)Parent-education intervention, also known as the Caregiver Education Model (CEM): focuses on teaching parents information about autism, behavior modification, and community services using a manualized approach (Brereton & Tonge, 2005). Parents will receive information on child development each week, and will be able to ask questions and discuss the information vis-à-vis their own child. This intervention is manualized (Brereton & Tonge 2005). In the CEM condition, parents meet in a group, without their children, in a community-based setting to receive the intervention. Intervention in both conditions occurs for 2 hours for 12 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 (Care Provider)

入排标准

年龄范围
24 Months 至 60 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children must be between 24 months and 60 months at entry into the study
  • Children must have a clinical diagnosis of autism or PDD-NOS, and/or meet criteria on the ADOS for ASD or autism
  • Children must have an age equivalent of 12 months or greater for non-verbal ability based on the Mullen Visual Reception and Fine Motor scales
  • Caregiver and child must be available for all assessments
  • Children must be able to walk independently
  • Parents must be between the ages of 16 and 50 years old
  • Family should be currently underserved (inability to obtain services for their child) and have limited family resources

排除标准

  • Children must not have a seizure disorder
  • Children must not have associated sensory (uncorrected hearing loss greater than 20 db or vision loss) or physical disorders that restrict mobility (e.g., cerebral palsy)
  • Children must not have sustained a head injury
  • Children's diagnosis of autism spectrum disorder must not be comorbid with other medical syndromes (e.g., Tuberose Sclerosis, Neurofibromatosis, Down syndrome, fragile X) or diseases
  • Children must not be in foster care
  • English must be the primary language spoken at home
  • Parents must not have a psychiatric diagnosis or a diagnosis of mental retardation

结局指标

主要结局

Early Social Communication Scale

时间窗: Before treatment, after treatment and 3 months after treatment

次要结局

  • Mullen Scales of Early Learning(Before treatment, after treatment, and 3 months after treatment)

研究者

发起方
Health Resources and Services Administration (HRSA)
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Connie Kasari, Ph.D.

Professor of Psychological Studies in Education and Psychiatry

Health Resources and Services Administration (HRSA)

研究点 (10)

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