Using a telemedicine tool to assess autism symptoms in toddlers
Addressing Disparities in ASD Diagnosis Using a Direct-to-home Telemedicine Tool: Evaluation of Diagnostic Accuracy, Psychometric Properties, and Family Engagement
This study is testing a new telemedicine tool to see if it can accurately assess autism symptoms in toddlers, comparing it to traditional in-person evaluations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 720 (estimated) |
| Ages | 18 Months to 42 Months |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT05047224 on ClinicalTrials.gov |
What this trial studies
This study evaluates the TELE-ASD-PEDS (TAP), a telemedicine tool designed to assess autism spectrum disorder (ASD) symptoms in toddlers aged 18-42 months. The study will recruit 360 toddlers across two sites, Vanderbilt University Medical Center (VUMC) and the University of California, Davis, and will compare telemedicine assessments with traditional in-person evaluations. Participants will be randomized to receive either a combination of telemedicine and in-person assessments or telemedicine assessments only. The study aims to measure the diagnostic accuracy of TAP and gather insights on family engagement and perceptions of the diagnostic process over six months.
Who should consider this trial
Good fit: Ideal candidates are toddlers aged 18-42 months who live within a 3-hour driving radius of the study sites and have access to necessary technology.
Not a fit: Patients with severe sensorimotor impairments or complex medical conditions that complicate tele-evaluation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve access to timely and accurate ASD diagnoses for families, particularly those in underserved areas.
How similar studies have performed: While telemedicine assessments have been used during the COVID-19 pandemic, this specific approach comparing tele-assessment with in-person evaluations in a diverse sample is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Sacramento, California
- UC Davis MIND Institute — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Zachary Warren, Ph.D. — Vanderbilt University Medical Center
- Study coordinator: Laura Corona, Ph.D.
- Email: Laura.L.Corona@vumc.org
- Phone: 615-936-5777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.