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临床试验/NCT05098392
NCT05098392终止不适用

Effects of Sibling-Mediated Intervention on Early Literacy and Social Reciprocity for Children With Autism

Arizona State University4 个研究点 分布在 2 个国家目标入组 8 人开始时间: 2021年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
4
主要终点
Change in social engagement

研究概览

简要总结

Given the increasing prevalence of autism spectrum disorder (ASD), estimated to be 1 in 68 in the United States alone, ASD has become one of the fastest-growing pediatric concerns. The deficits of children with ASD range across social communication and academic skills. One of the effective interventions that have been used commonly for ASD is the model-lead-test, which includes modeling, prompting children to practice target skills together, and providing children with affirmative feedback or error correction. Previous research has demonstrated that the model-lead-test is successful in teaching different skills for individuals with ASD, including functional, social, and academic skills. The vast majority of the studies had researchers, therapists, or teachers implement the intervention. However, there is clear empirical support and implications for interventions mediated by more familiar persons, such as parents and siblings, which may lead to better effects, maintenance, and generalization due to more practice opportunities in the natural environments. Research has supported the effectiveness of using parents or peers as agents to deliver interventions for individuals with ASD, whereas fewer studies explored the use of siblings to deliver or mediate intervention. As typically developing siblings are an essential part of the daily life of children with ASD, it makes logical extensions to have siblings as mediators to deliver interventions.

In the initial findings, the investigators found the typically developing siblings can accurately implement the model-lead-test procedure that improved various skills of their siblings with ASD. This project will extend these findings by examining the efficacy of the sibling-implemented intervention on early literacy (reading) and social reciprocity (conversation and play) of children with ASD as well as the sibling relationship before, during, and after the intervention.

详细描述

Prescreening:

Before the study, the investigators at each site will review existing assessment information for each participant with autism, which may include age, gender, IQ, autism, and behavioral scales, and verbal language functioning to confirm the children that meet the inclusion criteria.

Each dyad's involvement will last over the course of approximately 12 months. The first 3 months will be the intervention and data will be collected throughout. Follow-up data will be collected 3, 6, and 9 months after the intervention is concluded.

The study will involve the following components:

Pre-Assessments:

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)

盲法说明

The outcome assessor will not be informed of the group status of the children.

入排标准

年龄范围
5 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Both siblings can demonstrate compliance during instruction.
  • Children with ASD can imitate physical actions and repeat vocalizations, answering common questions, label common objects and actions with adjectives.
  • Typically developing children can sound out and blend letters during reading.

排除标准

  • Children with aggression towards their siblings and noncompliance during instruction
  • Children with ASD who can sound out and blend letters.

结局指标

主要结局

Change in social engagement

时间窗: Assessment will begin from the date of randomization, during and after the intervention, and up to 9 months after the intervention for a total of approximately 12 months

Children will play with their siblings for 15 minutes. The interaction will be coded using the Playground Observation of Peer Engagement (POPE).

Change in oral reading accuracy

时间窗: Assessment will begin from the date of randomization, during and after the intervention, and up to 9 months after the intervention for a total of approximately 12 months

Participants in the US will complete DIBELS Grades K-1 Benchmark. Participants in China read pinyin's using a pinyin matrix

Change in sibling relationship

时间窗: Assessment will begin from the date of randomization, during and after the intervention, and up to 9 months after the intervention for a total of approximately 12 months

Parents will complete the "Sibling Inventory of Behavior" scale. The minimum value of the scale is 32, and the maximum value is 160. The scale measures multiple dimensions of the sibling relationship, including companionship, empathy, teaching, rivalry, conflict, avoidance. Higher values obtained in each of the dimensions mean a higher level of companionship, empathy, teaching, rivalry, conflict, or avoidance from the sibling.

Change in sibling self-efficacy.

时间窗: Assessment will begin from the date of randomization, during and after the intervention, and up to 9 months after the intervention for a total of approximately 12 months

Typically developing siblings will complete the investigator-created "Children's Self-Efficacy Scale for TD Siblings". The scale is broken down into four sections of four to ten items. Each item is rated from 0 indicating a lack of self-efficacy to 100 indicating confidence. Thus, the minimum score that can be obtained is 0 and the maximum score is 2,700.

Change in reciprocal conversation

时间窗: Assessment will begin from the date of randomization, during and after the intervention, and up to 9 months after the intervention for a total of approximately 12 months

Children will play with their siblings for 15 minutes. Components in reciprocal conversation, such as answering questions, expansion, and reciprocal question-asking will be coded.

次要结局

  • Change in oral retell(Assessment may begin from the date of randomization, after the intervention, and up to 9 months after the intervention for a total of approximately 12 months)
  • Social validity(Immediately after the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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