Addressing Disparities in Autism Spectrum Disorder Diagnosis Using a Direct-to-home Telemedicine … (NCT05047224) | Clinical Trial Compass
CompletedNot Applicable
Addressing Disparities in Autism Spectrum Disorder Diagnosis Using a Direct-to-home Telemedicine Tool
United States664 participantsStarted 2021-12-03
Plain-language 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.
Who can participate
Age range
18 Months – 42 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic accuracy of the TAP
Timeframe: Baseline to completion of in-person autism evaluation, approximately two weeks
2
Validity of the TAP
Timeframe: Baseline to completion of in-person autism evaluation, approximately two weeks