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NCT05373173 · ClinicalTrials.gov registry record · NA

Can a Novel Telemedicine Tool Reduce Disparities Related to the Identification of Preschool Children With Autism?

A NA study, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
NA
Development phase
148
Enrollment target

NCT05373173: Completed NA study, sponsored by Vanderbilt University Medical Center.

NCT05373173 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 148 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05373173, a NA study, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
NA
Development phase
148 participants
Enrollment target

Study 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

Primary Outcome

Clinicians rated diagnostic certainty on a 4-point Likert Scale. Possible scores range from 1 to 4, with 1 indicating "Completely Uncertain," 2 indicating "Somewhat Uncertain," 3 indicating "Somewhat Certain" and 4 indicating "Completely Certain." Higher values reflect stronger clinician diagnostic certainty.

Interventions

  • BEHAVIORAL Tele-assessment only
  • BEHAVIORAL Tele-assessment + In-person assessment

Trial Details

FieldValue
Enrollment Target 148 participants
Start Date 2022-06-01
Est. Completion 2024-08-14
Phase NA

What the finished NCT05373173 record still lists

NCT05373173 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which Tele-assessment only is the first listed.

NCT05373173 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05373173 about?

NCT05373173 is a clinical study titled "Can a Novel Telemedicine Tool Reduce Disparities Related to the Identification of Preschool Children With Autism?". 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 i...

What is the current status of trial NCT05373173?

This trial is currently completed. It is a NA study. The enrollment target is 148 participants. The study started on 2022-06-01. Estimated completion is 2024-08-14.

What interventions are being tested in trial NCT05373173?

The interventions under investigation include: Tele-assessment only (BEHAVIORAL), Tele-assessment + In-person assessment (BEHAVIORAL).

Who is sponsoring clinical trial NCT05373173?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05373173's enrollment target sits among peer trials

148 702nd of 2000 higher than 1,298 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05373173, the US trial registry maintained by the National Library of Medicine. NCT05373173 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.