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

September 13, 2023 updated by: University of California, Davis

Evaluating the Impact of Telehealth-Based Autism Spectrum Disorder 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
No Intervention: Comparison
No additional materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent Stress Index 4th Edition, Short Form
Time Frame: Change from baseline at 12 weeks
Mean Score
Change from baseline at 12 weeks
Parent Sense of Competence
Time Frame: Change from baseline at 12 weeks
Mean Score
Change from baseline at 12 weeks
Telehealth Usability Questionnaire
Time Frame: Change from baseline at 12 weeks
Mean Score
Change from baseline at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Meagan Talbott, Ph.D., University of California Davis, MIND Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

May 31, 2033

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1749700
  • UL1TR001860 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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