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NCT Number: NCT04881656

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

6 month–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis Health

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: HIIYH

Primary outcomes

  1. Parent Stress Index 4th Edition, Short Form

    Time frame: Change from baseline at 12 weeks

    Mean Score

  2. Parent Sense of Competence

    Time frame: Change from baseline at 12 weeks

    Mean Score

  3. Telehealth Usability Questionnaire

    Time frame: Change from baseline at 12 weeks

    Mean Score

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2033
First posted
May 11, 2021
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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