Evaluating the Impact of Telehealth-Based ASD Assessments and Supports on Child and Caregiver Outcomes

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Other: Help is in Your Hands


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott). Exclusion Criteria: No previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott).

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIIYH<br>Help is in Your Hands is a series of online modules for parents with narrated videos of specific interactive strategies for supporting toddlers' communication development. | Other: Help is in Your Hands<br>* HIIYH is a set of 16 online educational modules for caregivers of children with social-communication delays or elevated likelihood of ASD.<br>* Other names: HIIYH;|
| No Intervention: Comparison<br>No additional materials | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent Stress Index 4th Edition, Short Form | Mean Score | Change from baseline at 12 weeks | 
| Parent Sense of Competence | Mean Score | Change from baseline at 12 weeks | 
| Telehealth Usability Questionnaire | Mean Score | Change from baseline at 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autism, telehealth