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

April 2, 2026 updated by: Zachary Warren, Vanderbilt University Medical Center

Addressing Disparities in ASD Diagnosis Using a Direct-to-home Telemedicine Tool: Evaluation of Diagnostic Accuracy, Psychometric Properties, and Family Engagement

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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. This study will recruit 360 toddlers (18-42 months of age) across two sites (VUMC and the University of California, Davis). All toddlers will receive in-home telemedicine assessment for ASD using the TAP. This study has two aims. The first aim will randomize participants to receive either (1) telemedicine assessment and an in-person ASD assessment or (2) telemedicine-based assessment only. The investigators will measure diagnostic accuracy of the TAP in comparison to gold standard, in-person ASD assessment. The investigators will also assess test-retest reliability, inter-rater reliability, and the sensitivity, specificity, and positive predictive value of the TAP. In the second aim, all 360 families will be followed over six months to evaluate service access, family engagement, and family perceptions of the diagnostic process.

Study Type

Interventional

Enrollment (Estimated)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Uc Davis Mind Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for Children:

  • 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)

Inclusion Criteria for Caregivers:

  • 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.

Exclusion Criteria for Children:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tele-assessment + in-person assessment
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
Participants will complete a tele-assessment using the TAP. They will complete a traditional, in-person autism spectrum disorder assessment approximately two weeks later.
Active Comparator: Tele-assessment only
Participants in this group will receive a tele-assessment using the TAP, followed by a second, shorter tele-assessment.
Behavioral: Tele-assessment only
Participants will complete a tele-assessment using the TAP. They will complete a second, shorter tele-assessment approximately two weeks later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of the TAP
Time Frame: Baseline to completion of in-person autism evaluation, approximately two weeks
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
Time Frame: Baseline to completion of in-person autism evaluation, approximately two weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family perceptions of tele-assessment
Time Frame: Baseline
Family perceptions of tele-assessment will be measured by the Parent Perceptions of Telemedicine (PPT) survey. The PPT is an 11-question survey. Seven questions are measured on a three-point scale and will provide quantitative data. Each question ranges from 1 (not true) to 3 (very true). Possible survey scores can range from 7 to 21. Higher scores indicate more positive perceptions of tele-assessment.
Baseline
Family satisfaction with diagnostic services
Time Frame: Baseline and six-month follow-up
Family satisfaction with diagnostic services will be measured by the Parent Service Satisfaction (PSS) survey. The PSS is an 7-question survey. Questions are measured on a three-point scale ranging from 1 (not true) to 3 (very true). Possible survey scores can range from 7 to 21. Higher scores indicate higher satisfaction with diagnostic services.
Baseline and six-month follow-up
Family empowerment
Time Frame: Baseline and six-month follow-up
Family empowerment will be measured using the Family Empowerment Scale (FES), which asks questions about caregiver self-efficacy related to understanding, navigating, and supporting their child's needs. The FES is an 24-question survey. Questions are measured on a five-point scale ranging from 1 (never) to 5 (very often). Possible survey scores can range from 24 to 120. Higher scores indicate greater self-perceived empowerment.
Baseline and six-month follow-up
Child service access and utilization
Time Frame: Baseline to six-month follow-up
Child service access and use will be measured using the Service Access and Utilization (SAU) questionnaire. The questionnaires asks about receipt of Part C early intervention services as well as private therapy services. Caregivers will complete the questionnaire at seven time points (approximately 15, 30, 45, 60, 90, 120, and 180 days following initial evaluation). At each time point, caregivers will endorse service milestones they have reached (e.g., scheduled an evaluation with the Part C service system, created an Individualized Family Service Plan, began services). We will calculate time to each milestone for each participant.
Baseline to six-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Zachary Warren, Ph.D., Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2021

Primary Completion (Actual)

March 10, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (Actual)

September 17, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 210760
  • 1R01MH127228-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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