An interventional study of Tele-assessment + in-person assessment and Tele-assessment only in Autism Spectrum Disorder, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Months to 42 Months. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Diagnostic
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.
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.
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Inclusion Criteria for Children:
Inclusion Criteria for Caregivers:
Exclusion Criteria for Children:
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 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 traditional, in-person autism spectrum disorder assessment approximately two weeks later.
Participants will complete a tele-assessment using the TAP. They will complete a second, shorter tele-assessment approximately two weeks later.
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.
Time frame: 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.
Time frame: Baseline to completion of in-person autism evaluation, approximately two weeks
Family perceptions of tele-assessment
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.
Time frame: Baseline
Family satisfaction with diagnostic services
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.
Time frame: Baseline and six-month follow-up
Family empowerment
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.
Time frame: Baseline and six-month follow-up
Child service access and utilization
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.
Time frame: Baseline to six-month follow-up
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Plan to share: No
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Vanderbilt University Medical Center