NCT05373173: TAP-P

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

Completed NA Results posted Last updated 24 August 2025

What this trial tests

NA trial testing Tele-assessment + In-person assessment in Autism Spectrum Disorder in 148 participants. Completed in 14 August 2024.

Timeline

1 June 2022

Primary endpoint
14 August 2024

14 August 2024

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	148
Start date	1 June 2022
Primary completion	14 August 2024
Estimated completion	14 August 2024
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 36 Months to 72 Months, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Diagnostic Certainty: Tele-assessment Primary · Single timepoint: Immediately after completing tele-assessment, an average of 90 minutes

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.

Group	Value	95% CI
Tele-assessment Only	3.07	± 0.83
Tele-assessment + In-person Assessment	2.85	± 0.99

Family Satisfaction Primary · Single timepoint: Immediately after completing tele-assessment, an average of 90 minutes

Parents will complete the Parent Perceptions of Telehealth survey to assess perceptions of tele-assessment procedures. The survey includes seven questions with three response options per questions (Very True, Somewhat True, Not True). The percentage of parents endorsing "very true" is reported.

Before I started my child's telehealth visit, I understood what I would be doing.

Group	Value	95% CI
Tele-assessment Only	96.3
Tele-assessment + In-person Assessment	93.0

The instructions the psychologist gave me abouthow to play with my child were easy to follow.

Group	Value	95% CI
Tele-assessment Only	96.3
Tele-assessment + In-person Assessment	98.2

The activities got my child to show the behaviors I am concerned about.

Group	Value	95% CI
Tele-assessment Only	38.5
Tele-assessment + In-person Assessment	51.8

I felt comfortable receiving feedback about my child over telehealth.

Group	Value	95% CI
Tele-assessment Only	92.6
Tele-assessment + In-person Assessment	95.6

The telehealth visit lasted the right amount of time.

Group	Value	95% CI
Tele-assessment Only	77.8
Tele-assessment + In-person Assessment	91.2

I would recommend participating in this kind of telehealth evaluation to others.

Group	Value	95% CI
Tele-assessment Only	81.5
Tele-assessment + In-person Assessment	90.4

The telehealth technology was easy to use.

Group	Value	95% CI
Tele-assessment Only	100
Tele-assessment + In-person Assessment	91.9

Diagnostic Certainty: In-person Assessment Primary · Single timepoint: Immediately after completing tele-assessment, an average of 180 minutes

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.

Group	Value	95% CI
Tele-assessment + In-person Assessment	3.64	± 0.67

Diagnostic Accuracy of TAP-P Primary · Single timepoint: Calculated immediately after completion of in-person assessment

For the preliminary tele-assessment only arm, diagnostic accuracy reflects the percentage of participants for whom the tele-assessment clinician's diagnostic impression (autism vs not autism) was in agreement with the child's existing diagnosis (autism vs not autism). For the tele-assessment + in-person assessment arm, diagnostic accuracy reflects the percentage of participants for whom the tele-assessment clinician's diagnostic impression (autism vs not autism) was in agreement with the diagnostic determination following in-person assessment (autism vs not autism).

Group	Value	95% CI
Tele-assessment Only	60
Tele-assessment + In-person Assessment	81.9

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.