Can Novel Telemedicine Tools Reduce Disparities Related to Early Identification of Autism

• ClinicalTrials.gov Identifier: NCT03847337
• Recruitment Status: Completed
• First Posted: February 20, 2019
• Last Update Posted: January 12, 2022
• Sponsor: Vanderbilt University Medical Center
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Zachary Warren, Vanderbilt University Medical Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Autism Spectrum Disorder; Developmental Delay	Other: Telehealth-Screening Tool for Autism in Toddlers (STAT); Other: Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)	Not Applicable

Detailed Description:

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)

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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).	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).	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

Outcome Measures

Primary Outcome Measures :

1. Accurate diagnosis of autism via telemedicine [ Time Frame: 1 day ]
   Number of children who are accurately diagnosed with autism as verified by medical record
2. Accurate diagnosis of developmental delay via telemedicine [ Time Frame: 1 day ]
   Number of children who are accurately diagnosed via diagnostic evaluation

Eligibility Criteria

• Ages Eligible for Study: 15 Months to 3 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37212

Sponsors and Collaborators

Vanderbilt University Medical Center

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Zachary E Warren, PhD; Vanderbilt University Medical Center

More Information

• 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
• 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

Keywords provided by Zachary Warren, Vanderbilt University Medical Center:

telemedicine

Additional relevant MeSH terms:

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders