NCT05047224

Addressing Disparities in Autism Spectrum Disorder Diagnosis Using a Direct-to-home Telemedicine Tool

Addressing Disparities in ASD Diagnosis Using a Direct-to-home Telemedicine Tool: Evaluation of Diagnostic Accuracy, Psychometric Properties, and Family Engagement

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Months – 42 Months
• Healthy volunteers: Not accepted

Summary

The investigators propose to evaluate the use of a telemedicine tool, the TELE-ASD-PEDS (TAP), that is designed to assess for autism spectrum disorder (ASD) symptoms in toddlers. The TAP was developed at VUMC by a team of clinical psychologists with expertise in the early identification of ASD. The TAP has been studied in controlled laboratory settings, with high levels of family and clinician satisfaction, as well as excellent agreement with blinded comprehensive ASD evaluation. The TAP has also been used to complete direct-to-home telemedicine assessments during the COVID-19 pandemic. However, the investigators have not yet compared direct-to-home assessments using the TAP with gold standard, in-person ASD assessments. It has also not yet been studied in a diverse sample of families or with providers outside of VUMC. This study will allow the investigators to address those gaps.

Detailed description

The investigators propose to evaluate the use of a telemedicine tool, the TELE-ASD-PEDS (TAP), that is designed to assess for autism spectrum disorder (ASD) symptoms in toddlers. This study will recruit 360 toddlers (18-42 months of age) across two sites (VUMC and the University of California, Davis). All toddlers will receive in-home telemedicine assessment for ASD using the TAP. This study has two aims. The first aim will randomize participants to receive either (1) telemedicine assessment and an in-person ASD assessment or (2) telemedicine-based assessment only. The investigators will measure diagnostic accuracy of the TAP in comparison to gold standard, in-person ASD assessment. The investigators will also assess test-retest reliability, inter-rater reliability, and the sensitivity, specificity, and positive predictive value of the TAP. In the second aim, all 360 families will be followed over six months to evaluate service access, family engagement, and family perceptions of the diagnostic process.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Tele-assessment + in-person assessment	Participants will complete a tele-assessment using the TAP. They will complete a traditional, in-person autism spectrum disorder assessment approximately two weeks later.
BEHAVIORAL	Tele-assessment only	Participants will complete a tele-assessment using the TAP. They will complete a second, shorter tele-assessment approximately two weeks later.

Timeline

• Start date: 2021-12-03
• Primary completion: 2026-03-10
• Completion: 2026-06-30
• First posted: 2021-09-17
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States