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

NCT04881656 | Active Not Recruiting

• 2 other identifiers: 1749700UL1TR001860
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

autism; telehealth

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

HIIYH

EXPERIMENTAL

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

Comparison

NO INTERVENTION

No additional materials

Interventions

Help is in Your Hands OTHER

HIIYH is a set of 16 online educational modules for caregivers of children with social-communication delays or elevated likelihood of ASD.

Also known as: HIIYH

HIIYH

Eligibility Criteria

• Age: 6 Months - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of California Davis Health

Sacramento, California, 95817, United States

Location

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Meagan Talbott, Ph.D.

  University of California Davis, MIND Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 11, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): May 31, 2033
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)