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

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04881656

Enrollment

Registered

2021-05-11

Start date

2021-09-01

Completion date

2033-05-31

Last updated

2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

autism, telehealth

Brief 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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 99 Years

Healthy volunteers

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).

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026