跳至主要内容
临床试验/NCT00999778
NCT00999778已完成不适用

Optimizing Social and Communication Outcomes for Toddlers With Autism

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2008年7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
入组人数
86
试验地点
2
主要终点
Cognitive Assessment - Mullen Scales of Early Learning (MSEL)

研究概览

简要总结

This project will examine the efficacy of two different treatment approaches aimed at facilitating change in social and communications outcomes of toddlers with autism.

详细描述

The proposed research tests a theoretically and empirically derived treatment approach aimed at facilitating change in joint attention interactions between caregivers and their toddlers with autism. Young children with autism show impairments in engaging in joint attention skills such as pointing and showing. The importance of joint attention is underscored by data showing that these skills are important to later development of language. Yet these interaction and skills deficits have rarely been the focus of systematic intervention efforts, particularly with caregivers. Moreover, current interventions for young children wiht autism are behavioral in approach, therapist driven, and often exclude the lowest functioning and developmentally youngest children. Thus, targeting these deficits in developmentally young children using familiar caregivers may result in better language outcomes for these children.

The overarching goal of the proposed project is to rigorously test an intervention program for caregivers and their toddlers with autism that is developmentally informed, child-centered and focused on joint attention intervention with their toddlers versus mothers who receive parent education about autism and child development.

The Primary aims of this research are as follows:

  • Aim 1: To determine if caregiver mediated intervention on joint engagement is superior to caregiver education on social communication and language outcomes in children.
  • Aim 2: To determine if skill development in the context of caregiver child interaction transfers to interactions with classroom teachers and peers.
  • Aim 3: To examine characteristics of families and children that best predict social-communication outcome.

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
18 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Child meets screening criteria for PDD
  • Not currently enrolled in a pre-existing intervention program
  • Parent is available for intervention
  • Child must be ready to start in the Early Childhood Partial Hospitalization Program (ECPHP) at UCLA

排除标准

  • Child does not have other sensory or genetic disorders
  • Children already on medication on the outset, although we find few toddlers already on medication when they begin treatment. If children begin medication after treatment commences, then we will keep all informatin and data pertaining to possible medication effects and statistically convey medication use if necessary
  • Co-morbidity, participant diagnosed with other diseases
  • Family/participant unable to follow-up

结局指标

主要结局

Cognitive Assessment - Mullen Scales of Early Learning (MSEL)

时间窗: Before treatment begins and at the 6 month follow up

Language Assessment - Reynell Developmental Language Scales

时间窗: Before treatment begins and at 6 month follow up

次要结局

  • Caregiver-child interaction - A 10-minute interaction between parent and child(Pre-intervention, 3 times turing active intervention, post treatment and at 3 and 6 months follow-up)
  • Language Sample - The Caregiver Child Interaction will be coded at each timepoint to obtain a 10 minute sample of the child's language transcription will yield a measure of lexical density, type-token ration and mean length of utterances(Prior to Intervention, two follow up points 3 month post intervention and 6 months post intervention)
  • Early Social-Communication Scales; frequencies of initiating and responses of joint attention behaviors to toys and l interaction - sessions will be video taped(Before intervention, at the end of intervention and at the 3 and 6 month follow up)
  • MacArthur Communicative Development Inventories(Before Intervention, after intervention at 3 month and 6 month follow ups)
  • Parent Expectancy/Belief in the Intervention - assesses caregiver beliefs that the intervention is appropriate and working for the child(Before intervention and once during each phase of the intervention for total of 3 ratings (during intervention))
  • ADOS - The Autism Diagnostic Observation Schedule - semi-structured, standardized assessment of communication, social interaction, play and imaginative use of materials(Prior to intervention (determines eligibility) and 6 months post intervention)
  • Generalization of skills to classroom - Observational measure to determine whether child show generalization of skill to the classroom,and in interaction with teachers & peers(Prior to intervention and once during each phase of intervention)
  • Coding of child behaviors in classroom - using time sampling procedure, four different contexts; direct instruction, structure play, circle-time, unstructured play(during intervention)
  • ADI-R Clinical diagnostic instrument for assessing autism in children(Prior to intervention to determine eligibility for participation in the study)
  • Parenting Stress - The Parenting Stress Index (PSI) measuring parents reported stress associated with the care of autistic child(Prior to interventin, at the end of intervention and 6 month follow-up)

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih
责任方
Principal Investigator
主要研究者

Connie Kasari

Professor of Psychological Studies in Education and Psychiatry

University of California, Los Angeles

研究点 (2)

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