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临床试验/NCT03840642
NCT03840642已完成不适用

Examining an Adaptive Telehealth Intervention for Young Children With Autism Spectrum Disorder

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2018年1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
61
试验地点
2
主要终点
Change in Unstructured Imitation Assessment (UIA)

研究概览

简要总结

The purpose of this study is to explore the acceptability and effects of internet-based approaches for helping parents learn early intervention strategies (e.g., methods or tips for improving a child's behavior and development). As part of this study, families will be randomly(selected by chance like the flip of a coin) assigned to one of two different formats of an interactive telehealth program called Mirror Me. One format families complete on their own, the other involves the option to meet with a parent coach over the internet for feedback. The goal of the study is to understand how parents/caregivers and children benefit from using online programs, and to identify barriers (blocks) and facilitators (helpers) to this kind of service delivery model.

详细描述

Mirror Me is a telehealth parent training intervention that teaches parents to promote their child's social imitation during play and daily routines. It uses content from Reciprocal Imitation Training (RIT), an evidence-based NDBI that teaches social imitation within affect-laden playful interactions. RIT techniques include imitating the child (contingent imitation), modeling language, behavioral prompting, and natural reinforcement during child-direct activities. There is strong empirical support for the effect of individual techniques on imitation, joint attention, and language and RIT has been cited as one of only seven early intervention packages with "strong" evidence of efficacy with children < 3 with ASD or at risk for ASD. Because RIT focuses on a skill that emerges early in development and does not require language competency, it can be used with children at very young chronological, language, and developmental levels, making it an ideal early intervention. Given that RIT is meant to be used in a child's natural environment and only involves a handful of intervention techniques, it is well suited for delivery in a parent training format, with initial data supporting the effectiveness of parent training in RIT. Mirror Me presents intervention content in four interactive modules. Program development was guided by the technology acceptance model, media richness theory, and principles of instructional design. To ensure usability and acceptability, the investigators used an iterative development process with input from pilot participants. The investigators have subsequently upgraded the website to ensure mobile compatibility, user-friendly material, and enhanced assessment and monitoring capabilities. Mirror Me can be used as a standalone website or in combination with remote parent "coaching." Initial data indicate roughly one third to one half of parents learn RIT techniques from the website alone, while the rest require coaching. These data support the investigation of a stepped-care telehealth intervention, where parents use the Mirror Me website and then receive remote parent coaching, if the anticipated response to the program is not observed.

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
16 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • a pre-existing diagnosis of ASD
  • behaviorally-based caregiver concerns about ASD
  • behaviorally-based physician concerns about ASD
  • a positive screen on a validated ASD screening tool.
  • a score of 40% or less on the Unstructured Imitation Assessment (UIA) at screening/baseline

排除标准

  • 未提供

结局指标

主要结局

Change in Unstructured Imitation Assessment (UIA)

时间窗: Baseline, Week 10, and Week 15

An assessment that is used to measure a child's ability to imitate in a spontaneous, social-interactive context. A higher summed score on this assessment indicates better imitation abilities.

Change in Early Intervention Parenting Self Efficacy Scale

时间窗: Baseline, Week 5, Week 10, Week 15

Asks about the extent to which parents feel as though they have the skills and knowledge to help their child's development. A higher summed score on this scale indicates greater parental self-efficacy

Change in Parent Fidelity

时间窗: Baseline, Week 5, Week 10, Week 15

Ten minute parent-child play interactions videos that will be saved and later coded by trained research assistants who will be blinded to study condition.

次要结局

  • Change in Vineland Scales of Adaptive Functioning (3rd edition, survey form)(Baseline, Week 10, Week 15)
  • Change in Social Communication Checklist Revised(Baseline, Week 10, Week 15)

研究者

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

Allison Wainer, Ph.D.

Assistant Professor

Rush University Medical Center

研究点 (2)

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