跳至主要内容
临床试验/NCT04881656
NCT04881656进行中(未招募)不适用

Evaluating the Impact of Telehealth-Based Autism Spectrum Disorder Assessments and Supports on Child and Caregiver Outcomes

University of California, Davis2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
2
主要终点
Parent Stress Index 4th Edition, Short Form

研究概览

简要总结

The overall goal of this study is to evaluate telehealth and internet-based approaches to meet accessibility challenges for families with concerns about ASD in their infants. In this study, we will gather exploratory data related to the potential of two telehealth tools: 1) The Telehealth Evaluation of Development for Infants (TEDI); and 2) "Help is in Your Hands" (HIIYH), a set of video materials and information on interactive strategies parents can use to support their child's communication development. We will recruit families participating in an ongoing study using the TEDI (R21 HD100372, PI: Talbott) to evaluate infants' behavioral development. As families exit the parent TEDI study and enter the current study, we will ask parents to complete online questionnaires, and randomize them to either receive immediate access to additional online materials (HIIYH) for parents or no additional materials. After 12 weeks, parents will complete online questionnaires and all families will then be given access to the online materials. When children reach 30 months, we will collect additional questionnaires, complete a live telehealth behavioral session with toddlers and their caregivers, and conduct an exit interview with parents to gather feedback about their experience.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Months 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott).

排除标准

  • No previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott).

结局指标

主要结局

Parent Stress Index 4th Edition, Short Form

时间窗: Change from baseline at 12 weeks

Mean Score

Parent Sense of Competence

时间窗: Change from baseline at 12 weeks

Mean Score

Telehealth Usability Questionnaire

时间窗: Change from baseline at 12 weeks

Mean Score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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