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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT05373173
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
36 Months - 72 Months
Healthy Volunteers
Accepted

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 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.

Study Details

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.

Key Dates

Start date
Jun 1, 2022
Status verified
Aug 2025
Primary completion
Aug 14, 2024
Completion
Aug 14, 2024

Study Design

Enrollment
148 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Tele-assessment only
    Families will complete a tele-assessment only.
  • Experimental: Tele-assessment + In-person assessment
    All families will receive an in-person tele-assessment appointment and an in-person evaluation.

Primary Outcome Measure

Diagnostic Certainty: Tele-assessment [ Time Frame: Single timepoint: Immediately after completing tele-assessment, an average of 90 minutes ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37212-

Find similar trials in Nashville, TN

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Vanderbilt University Medical Center· Nashville, TN

Related Studies