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

Primary Purpose

Autism Spectrum Disorder, Developmental Delay

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth-Screening Tool for Autism in Toddlers (STAT)
Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Autism Spectrum Disorder focused on measuring telemedicine

Eligibility Criteria

15 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

New to diagnosis

Previously diagnosed

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Accurate Diagnosis of Autism Via Telemedicine
Number of children who are accurately diagnosed with autism via diagnostic evaluation
Accurate Diagnosis of Developmental Delay Via Telemedicine
Number of children who are accurately diagnosed via diagnostic evaluation

Secondary Outcome Measures

Full Information

First Posted
February 18, 2019
Last Updated
October 31, 2022
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03847337
Brief Title
Can Novel Telemedicine Tools Reduce Disparities Related to Early Identification of Autism
Official Title
Can Novel Telemedicine Tools Reduce Disparities Related to Early Identification of Autism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Developmental Delay
Keywords
telemedicine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New to diagnosis
Arm Type
Experimental
Arm Description
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).
Arm Title
Previously diagnosed
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Telehealth-Screening Tool for Autism in Toddlers (STAT)
Intervention Description
Structured autism screening tool
Intervention Type
Other
Intervention Name(s)
Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)
Intervention Description
Semi-structured autism screening tool
Primary Outcome Measure Information:
Title
Accurate Diagnosis of Autism Via Telemedicine
Description
Number of children who are accurately diagnosed with autism via diagnostic evaluation
Time Frame
1 day
Title
Accurate Diagnosis of Developmental Delay Via Telemedicine
Description
Number of children who are accurately diagnosed via diagnostic evaluation
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary E Warren, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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