An interventional study of Telehealth-Screening Tool for Autism in Toddlers (STAT) and Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS) in Autism Spectrum Disorder and Developmental Delay, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 15 Months to 3 Years. Per ClinicalTrials.gov, last updated 2022-11-29.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Diagnostic
In this study, the investigators are trying to find new ways to screen for autism spectrum disorder (ASD) in young children. The investigators want to see if people like pediatricians can screen children for ASD while a psychologist watches on a monitor. The investigators are testing two screening tools. The investigators want to see if they are good at identifying children with ASD and children without ASD. The investigators hope this research will make it easier for families to get answers when there are concerns for ASD.
The investigators will evaluate and compare two telemedicine assessment tools (TELE-STAT and TELE-ASD-PEDS) that could allow parents or naive providers in remote locations to complete an Autism Spectrum Disorder (ASD) risk assessment via telemedicine consultation via an expert psychologist. These tools will be low cost, compliant with privacy rules, easily deployed in community practice settings, and explicitly designed to work within paradigms that may be pragmatically and financially viable for systems of care housing remote clinicians. These telemedicine tools could provide methodologies wherein children could be rapidly linked to and appropriately assessed by ASD experts within practice locations where the children are currently receiving care. In turn, these children, who without such assessment may wait months or over a year in many circumstances to access assessments and interventions, may be able to receive appropriate ASD assessments within days or weeks of screening/surveillance concerns within practice settings where the children are already accessing and familiar with (i.e., minimizing loss to referral and follow-up)
1,755 studies on the registry are indexed under Autism Spectrum Disorder; 507 are open to participants now.
This study's enrollment of 144 is above the median of 52 across 1,391 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 159 are open to participants now.
Of its 124 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
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Exclusion Criteria:
We will test two telemedicine tools with children who have not been previously diagnosed with autism or developmental delay. The two telemedicine tools are the Screening Tool for Autism in Toddlers (TELE-STAT) and the Autism Spectrum Disorder (ASD-PEDS).
Other: Telehealth-Screening Tool for Autism in Toddlers (STAT) · Other: Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)
We will test two telemedicine tools with children who have been previously diagnosed with autism or developmental delay. The two telemedicine tools are the Screening Tool for Autism in Toddlers (TELE-STAT) and the Autism Spectrum Disorder (ASD-PEDS).
Other: Telehealth-Screening Tool for Autism in Toddlers (STAT) · Other: Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)
Structured autism screening tool
Semi-structured autism screening tool
Accurate Diagnosis of Autism Via Telemedicine
Number of children who are accurately diagnosed with autism via diagnostic evaluation
Time frame: 1 day
Accurate Diagnosis of Developmental Delay Via Telemedicine
Number of children who are accurately diagnosed via diagnostic evaluation
Time frame: 1 day
| Milestone | ASD-PEDS | TELE-STAT |
|---|---|---|
| Started | 73 | 71 |
| Completed | 73 | 71 |
| Not completed | 0 | 0 |
Number of children who are accurately diagnosed with autism via diagnostic evaluation
| Participants | ASD-PEDS | TELE-STAT |
|---|---|---|
| Accurate Diagnosis of Autism Via Telemedicine | 61 | 63 |
Number of children who are accurately diagnosed via diagnostic evaluation
| Participants | ASD-PEDS | TELE-STAT |
|---|---|---|
| Accurate Diagnosis of Developmental Delay Via Telemedicine | 7 | 2 |
Collected over Day of assessment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ASD-PEDS | 0/73 (0%) | 0/73 (0%) | 0/73 (0%) |
| TELE-STAT | 0/71 (0%) | 0/71 (0%) | 0/71 (0%) |
| Age, Continuous(years) | ASD-PEDS | TELE-STAT | Total |
|---|---|---|---|
| Median | 2.57 (1.71 to 3.02) | 2.58 (1.39 to 2.99) | 2.57 (1.39 to 3.02) |
| Sex: Female, Male(Participants) | ASD-PEDS | TELE-STAT | Total |
|---|---|---|---|
| Female | 26 | 15 | 41 |
| Male | 47 | 56 | 103 |
| Ethnicity (NIH/OMB)(Participants) | ASD-PEDS | TELE-STAT | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 3 | 10 |
| Not Hispanic or Latino | 56 | 63 | 119 |
| Unknown or Not Reported | 10 | 5 | 15 |
| Race (NIH/OMB)(Participants) | ASD-PEDS | TELE-STAT | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 11 | 18 |
| White | 59 | 49 | 108 |
| More than one race | 3 | 9 | 12 |
| Unknown or Not Reported | 3 | 1 | 4 |
| Region of Enrollment(participants) | ASD-PEDS | TELE-STAT | Total |
|---|---|---|---|
| United States | 73 | 71 | 144 |
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