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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04881656
• Other study ID #: 1749700
• Secondary ID: UL1TR001860
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: May 31, 2033

Study information

• Verified date: September 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: May 31, 2033
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• Help is in Your Hands
HIIYH is a set of 16 online educational modules for caregivers of children with social-communication delays or elevated likelihood of ASD.

Locations

Country	Name	City	State
United States	University of California Davis Health	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent Stress Index 4th Edition, Short Form	Mean Score	Change from baseline at 12 weeks
Primary	Parent Sense of Competence	Mean Score	Change from baseline at 12 weeks
Primary	Telehealth Usability Questionnaire	Mean Score	Change from baseline at 12 weeks

External Links

•   Learn more or sign up for the study here!