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

NCT05373173 | Completed Results

• 2 other identifiers: 220273R21MH128790
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Keywords

Autism; ASD; Telehealth; Preschool; Tele-assessment

Outcome Measures

Primary Outcomes (4)

• Diagnostic Certainty: Tele-assessment

  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.

  Single timepoint: Immediately after completing tele-assessment, an average of 90 minutes

• Family Satisfaction

  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.

  Single timepoint: Immediately after completing tele-assessment, an average of 90 minutes

• Diagnostic Certainty: In-person Assessment

  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.

  Single timepoint: Immediately after completing tele-assessment, an average of 180 minutes

• Diagnostic Accuracy of TAP-P

  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).

  Single timepoint: Calculated immediately after completion of in-person assessment

Study Arms (2)

Tele-assessment only

EXPERIMENTAL

Families will complete a tele-assessment only.

Behavioral: Tele-assessment only

Tele-assessment + In-person assessment

EXPERIMENTAL

All families will receive an in-person tele-assessment appointment and an in-person evaluation.

Behavioral: Tele-assessment + In-person assessment

Interventions

Tele-assessment + In-person assessment BEHAVIORAL

All consented families will complete an initial home-based tele-assessment visit via Zoom that includes the TAP-Preschool and a brief symptom-focused developmental interview with a consented clinician. The initial tele-assessment session includes interviewing and developmental assessment to mimic real-world use of TAP-Preschool. After the session, the examiner will record the clinical diagnosis issued (ASD, other developmental concerns, or typical development) and complete two diagnostic certainty ratings. All initial TAP-Preschool administrations will be recorded via Zoom, and 50% of administrations (randomly selected) will be co-scored by a blinded examiner, unaware of prior assessment results and diagnostic decision, to evaluate inter-rater reliability. Within 7 days of the remote assessment, families will participate in an in-person diagnostic assessment including common comprehensive measures of ASD, cognitive skills, and adaptive behavior.

Tele-assessment + In-person assessment

Tele-assessment only BEHAVIORAL

Consented families will complete home-based tele-assessment via Zoom that includes the TAP-Preschool. Each participant will have recent data available from comprehensive evaluation tools (ADOS-2, cognitive functioning, adaptive skills). After the session, participating caregivers will provide information about acceptability and challenges.

Tele-assessment only

Eligibility Criteria

• Age: 36 Months - 72 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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):
• 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

You may not qualify if:

• Initial deployment (n = 30):
• severe sensorimotor impairments
• Novel sample (n = 120):
• \- severe sensorimotor impairments

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

• Wagner L, Vehorn A, Weitlauf AS, Lavanderos AM, Wade J, Corona L, Warren Z. Development of a Novel Telemedicine Tool to Reduce Disparities Related to the Identification of Preschool Children with Autism. J Autism Dev Disord. 2025 Jan;55(1):30-42. doi: 10.1007/s10803-023-06176-3. Epub 2023 Dec 8.

  PMID: 38064003 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Zachary Warren, Ph.D.
• Organization: Vanderbilt University Medical Center

zachary.e.warren@vumc.org

615-875-3085

Study Officials

• Zachary Warren, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics; Director of the Division of Developmental Medicine

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 13, 2022
• Study Start: June 1, 2022
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: August 24, 2025
• Results First Posted: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)