N/A
N=148
Can a Novel Telemedicine Tool Reduce Disparities Related to the Identification of Preschool Children With Autism?
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05373173 ↗Enrolled (actual)
148
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Diagnostic Certainty: Tele-assessment — 3.07; 2.85 score on a scale (range 1-4)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tele-assessment + In-person assessment (Behavioral); Tele-assessment only (Behavioral)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Certainty: Tele-assessment |
3.07; 2.85 | — |
| PRIMARY Family Satisfaction |
96.3; 93.0; 96.3; 98.2; 38.5; 51.8 | — |
| PRIMARY Diagnostic Certainty: In-person Assessment |
3.64 | — |
| PRIMARY Diagnostic Accuracy of TAP-P |
60; 81.9 | — |
Summary
Families seeking evaluation for autism spectrum disorder (ASD) often face barriers such as low availability of specialists, lengthy waitlists, and long distances to tertiary care diagnostic centers. This is especially true for children from traditionally underserved groups and communities. Without innovative approaches for enhanced identification of ASD, families and clinicians will continue to struggle with accessing and providing care. Telemedicine offers tremendous potential for addressing this need, but there are few psychometrically sound, validated tools that can be administered remotely, via telehealth platforms. This team of investigators developed and conducted a preliminary evaluation of a novel parent-administered, clinician-guided tele-diagnostic tool, the TAP (TELE-ASD-PEDS), designed specifically for direct-to-home and community clinic use with toddlers. Remote administration of the TAP yielded a very high level of agreement with blinded comprehensive evaluation regarding ASD risk classification. Subsequently, the unanticipated broad dissemination of the TAP during COVID-19 demonstrated its value for traditionally underserved groups, spanning broad geographies. Although promising, this work was limited by its specific focus on toddlers with ASD concerns. A telemedicine tool designed for the unique context and population of preschool-aged children referred for diagnostic assessment could have tremendous value in terms of both accurate identification as well as family engagement with service. In the current work, the investigators will now evaluate the performance, usability, and utility of the TAP-Preschool, a new telemedicine tool for ASD risk assessment in preschoolers, through a clinical trial. The TAP-Preschool was developed through a computationally informed co-production in which the targeted population were recruited as active partners in designing the tool. The investigators will gather critical data not only regarding its structure and accuracy, but also its potential deployment across systems responsible for engaging children and families from underserved groups in meaningful service. This work has potential to transform the ASD evaluation process and dramatically improve care access for traditionally underserved groups.
Eligibility Criteria
Inclusion Criteria
- Initial deployment (n = 30):
- English/Spanish Speaking families
- Children 36-72 months of age
- access to a device capable of supporting Zoom
- already has participated in a diagnostic evaluation
Novel sample (n = 120):
Inclusion
- English/Spanish Speaking families
- Children 36-72 months of age
- access to a device capable of supporting Zoom
- has not participated in a diagnostic evaluation
Exclusion Criteria
- Initial deployment (n = 30):
- severe sensorimotor impairments
Novel sample (n = 120):
- severe sensorimotor impairments
Data sourced from ClinicalTrials.gov (NCT05373173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.