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

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

Interventions

BEHAVIORAL

Tele-assessment + In-person assessment

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.

BEHAVIORAL

Tele-assessment only

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Zachary Warren, PhD · Vanderbilt University Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

36 Months

Max Age

72 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2024-08-14

Completion

2024-08-14

Countries

• United States

Study Locations