Autism Spectrum DisorderNCT04881656
Evaluating the Impact of Telehealth-Based ASD Assessments and Supports on Child and Caregiver Outcomes
A study testing Help is in Your Hands in people with Autism Spectrum Disorder, run by University of California, Davis at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 99 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Help is in Your Hands
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 May 2033
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott).
Who cannot join
- No previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Health
Sacramento, California, 95817
About this study
Official title: 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Help is in Your Hands
- Keywords
- autism, telehealth
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Help is in Your HandsOther
Also called HIIYH
HIIYH is a set of 16 online educational modules for caregivers of children with social-communication delays or elevated likelihood of ASD.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Help is in Your Hands |
| Comparison | No intervention | No additional materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Stress Index 4th Edition, Short Form
Mean Score
Measured: Change from baseline at 12 weeks
Parent Sense of Competence
Mean Score
Measured: Change from baseline at 12 weeks
Telehealth Usability Questionnaire
Mean Score
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 Sep 2021
- Primary completion31 May 2033 (estimated)
- Study completion31 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Meagan Talbott, Ph.D., Principal investigator, University of California Davis, MIND Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881656
- Sponsor's protocol ID
- 1749700
- Other IDs
- UL1TR001860
- Status last verified
- Oct 2026
- First submitted
- 6 May 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No