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

NCT04881656 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-10-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Meagan Talbott, Ph.D. · University of California Davis, MIND Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2026-06-30
Completion
2033-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04881656 on ClinicalTrials.gov