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

NCT05047224 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Zachary Warren, Ph.D. · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
42 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-03
Primary Completion
2026-03-10
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05047224 on ClinicalTrials.gov