Addressing Disparities in Autism Spectrum Disorder Diagnosis Using a Direct-to-home Telemedicine Tool

NCT05047224 | Active Not Recruiting

• 2 other identifiers: 2107601R01MH127228-01
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to evaluate the use of a telemedicine tool, the TELE-ASD-PEDS (TAP), that is designed to assess for autism spectrum disorder (ASD) symptoms in toddlers. The TAP was developed at VUMC by a team of clinical psychologists with expertise in the early identification of ASD. The TAP has been studied in controlled laboratory settings, with high levels of family and clinician satisfaction, as well as excellent agreement with blinded comprehensive ASD evaluation. The TAP has also been used to complete direct-to-home telemedicine assessments during the COVID-19 pandemic. However, the investigators have not yet compared direct-to-home assessments using the TAP with gold standard, in-person ASD assessments. It has also not yet been studied in a diverse sample of families or with providers outside of VUMC. This study will allow the investigators to address those gaps.

Conditions

Autism Spectrum Disorder

Keywords

autism spectrum disorder; tele-assessment

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy of the TAP

  The investigators will compare diagnoses made from the tele-assessment using TAP to those from in-person evaluation. We will calculate the percent agreement between diagnoses assigned in each condition.

  Baseline to completion of in-person autism evaluation, approximately two weeks

• Validity of the TAP

  Validity of the TAP will be measured by assessing the psychometric properties of the tool. Estimated performance metrics will include positive predictive value (PPV), negative predictive value (NPV), sensitivity, and specificity of the TAP.

  Baseline to completion of in-person autism evaluation, approximately two weeks

Secondary Outcomes (4)

• Family perceptions of tele-assessment

  Baseline

• Family satisfaction with diagnostic services

  Baseline and six-month follow-up

• Family empowerment

  Baseline and six-month follow-up

• Child service access and utilization

  Baseline to six-month follow-up

Study Arms (2)

Tele-assessment + in-person assessment

EXPERIMENTAL

Participants in this group will receive a tele-assessment using the TAP and will attend a traditional, in-person evaluation for autism spectrum disorder in a clinic setting.

Behavioral: Tele-assessment + in-person assessment

Tele-assessment only

ACTIVE COMPARATOR

Participants in this group will receive a tele-assessment using the TAP, followed by a second, shorter tele-assessment.

Behavioral: Tele-assessment only

Interventions

Tele-assessment only BEHAVIORAL

Participants will complete a tele-assessment using the TAP. They will complete a second, shorter tele-assessment approximately two weeks later.

Tele-assessment only

Tele-assessment + in-person assessment BEHAVIORAL

Participants will complete a tele-assessment using the TAP. They will complete a traditional, in-person autism spectrum disorder assessment approximately two weeks later.

Tele-assessment + in-person assessment

Eligibility Criteria

• Age: 18 Months - 42 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child between 18 and 42 months of age
• Child and primary caregiver live within a 3-hour driving radius of one of the sites (i.e., VUMC or UC Davis)
• Age 18 years or older
• Parent or legal guardian of participating child
• Has access to technology (e.g., phone, laptop, or tablet with internet connection and audio-visual capabilities) to connect to the tele-assessment platform
• Sufficient facility with English to participate in the procedures and complete study measures.

You may not qualify if:

• Severe sensorimotor impairment that cannot be corrected and would interfere with completion of study activities
• Medical conditions for which tele-evaluation of ASD symptoms is likely to be inappropriate or complex (i.e., rare genetic syndromes, severe epilepsy, fragile health).

Sponsors & Collaborators

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

Study Sites (1)

UC Davis MIND Institute

Sacramento, California, 95817, United States

Location

Related Publications (2)

• Gangi DN, Corona L, Wagner L, Weitlauf A, Warren Z, Ozonoff S. In-home Tele-assessment for Autism in Toddlers: Validity, Reliability, and Caregiver Satisfaction with the TELE-ASD-PEDS. J Dev Behav Pediatr. 2025 Jun 17;46(3):e261-e268. doi: 10.1097/DBP.0000000000001358.

  PMID: 40526421 DERIVED

• Ozonoff S, Gangi D, Corona L, Foster T, Hill MM, Honaker M, Maqbool S, Ni R, Nicholson A, Parikh C, Stone C, Spitler AK, Swanson A, Vehorn A, Wagner L, Weitlauf A, Warren Z. Measuring Developmental Delays: Comparison of Parent Report and Direct Testing. J Autism Dev Disord. 2025 Dec;55(12):4492-4498. doi: 10.1007/s10803-024-06292-8. Epub 2024 Feb 26.

  PMID: 38407697 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Zachary Warren, Ph.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Clinicians conducting in-person diagnostic evaluations will be blind to the outcomes of initial telehealth diagnostic appointments until after in-person assessments are administered and scored. Clinicians will be unblinded to telehealth diagnostic outcomes prior to sharing the results of in-person assessment with families. Clinicians conducting the second telehealth appointments for test-retest and interrater reliability purposes will be blind to recruitment pathway and diagnostic outcome from the initial telehealth appointment.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 17, 2021
• Study Start: December 3, 2021
• Primary Completion: March 10, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)