CClinicalTrials.gg
Active, not recruitingNCT04881656Updated Oct 22, 2025

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

An interventional study of Help is in Your Hands in Autism Spectrum Disorder, sponsored by University of California, Davis. Active, not recruiting at 1 site in United States. Open to participants aged 6 Months to 99 Years. Per ClinicalTrials.gov, last updated 2025-10-22.

Sponsored by University of California, Davis · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
6 Months to 99 Years
Sex
All
01

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.

02

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • autism
  • telehealth
03

In context

Autism Spectrum Disorder

1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.

This study's planned enrollment of 80 is above the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    HIIYH

    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

  • No intervention
    Comparison

    No additional materials

Interventions

  • OtherHelp 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.

    Also known as: HIIYH

06

What researchers measure

Primary outcomes

  1. Parent Stress Index 4th Edition, Short Form

    Mean Score

    Time frame: Change from baseline at 12 weeks

  2. Parent Sense of Competence

    Mean Score

    Time frame: Change from baseline at 12 weeks

  3. Telehealth Usability Questionnaire

    Mean Score

    Time frame: Change from baseline at 12 weeks

07

Study locations

1 site
  • University of California Davis Health
    Sacramento, California 95817, United States
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04881656
Lead sponsor
University of California, Davis
Collaborators
National Center for Advancing Translational Sciences (NCATS)
Responsible party
Sponsor
First posted
May 11, 2021
Start date
Sep 1, 2021
Primary completion
Jun 30, 2026 (estimated)
Completion
May 31, 2033 (estimated)
Last update
Oct 22, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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