Can Novel Telemedicine Tools Reduce Disparities Related to Early Identification of Autism
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ClinicalTrials.gov Identifier: NCT03847337 |
Recruitment Status :
Completed
First Posted : February 20, 2019
Last Update Posted : January 12, 2022
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Condition or disease | Intervention/treatment | Phase |
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Autism Spectrum Disorder Developmental Delay | Other: Telehealth-Screening Tool for Autism in Toddlers (STAT) Other: Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Care Provider, Outcomes Assessor) |
Primary Purpose: | Diagnostic |
Official Title: | Can Novel Telemedicine Tools Reduce Disparities Related to Early Identification of Autism |
Actual Study Start Date : | March 4, 2019 |
Actual Primary Completion Date : | September 30, 2021 |
Actual Study Completion Date : | September 30, 2021 |

Arm | Intervention/treatment |
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Experimental: New to diagnosis
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).
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Other: Telehealth-Screening Tool for Autism in Toddlers (STAT)
Structured autism screening tool Other: Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS) Semi-structured autism screening tool |
Experimental: Previously diagnosed
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).
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Other: Telehealth-Screening Tool for Autism in Toddlers (STAT)
Structured autism screening tool Other: Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS) Semi-structured autism screening tool |
- Accurate diagnosis of autism via telemedicine [ Time Frame: 1 day ]Number of children who are accurately diagnosed with autism as verified by medical record
- Accurate diagnosis of developmental delay via telemedicine [ Time Frame: 1 day ]Number of children who are accurately diagnosed via diagnostic evaluation

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Ages Eligible for Study: | 15 Months to 3 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children who have been diagnosed with autism or developmental delay
Exclusion Criteria:
- Children with genetic disorders
- Children with medical complexities, such as blindness or deafness
- Children whose families do not speak English

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847337
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37212 |
Principal Investigator: | Zachary E Warren, PhD | Vanderbilt University Medical Center |
Responsible Party: | Zachary Warren, Associate Professor, Vanderbilt University Medical Center |
ClinicalTrials.gov Identifier: | NCT03847337 |
Other Study ID Numbers: |
190152 1R21MH118539-01 ( U.S. NIH Grant/Contract ) |
First Posted: | February 20, 2019 Key Record Dates |
Last Update Posted: | January 12, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
telemedicine |
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |