NCT03847337

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 29, 2022

Completed
Last Updated

November 29, 2022

Status Verified

October 1, 2022

Enrollment Period

2.6 years

First QC Date

February 18, 2019

Results QC Date

October 31, 2022

Last Update Submit

October 31, 2022

Conditions

Autism Spectrum DisorderDevelopmental Delay

Keywords

telemedicine

Outcome Measures

Primary Outcomes (2)

  • Accurate Diagnosis of Autism Via Telemedicine

    Number of children who are accurately diagnosed with autism via diagnostic evaluation

    1 day

  • Accurate Diagnosis of Developmental Delay Via Telemedicine

    Number of children who are accurately diagnosed via diagnostic evaluation

    1 day

Study Arms (2)

New to diagnosis

EXPERIMENTAL

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)

Previously diagnosed

EXPERIMENTAL

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)

Interventions

Telehealth-Screening Tool for Autism in Toddlers (STAT)OTHER

Structured autism screening tool

New to diagnosisPreviously diagnosed
Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)OTHER

Semi-structured autism screening tool

New to diagnosisPreviously diagnosed

Eligibility Criteria

Age15 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children who have been diagnosed with autism or developmental delay

You may not qualify if:

  • Children with genetic disorders
  • Children with medical complexities, such as blindness or deafness
  • Children whose families do not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderLearning Disabilities

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Zachary Warren
Organization
Vanderbilt University Medical Center
zachary.e.warren@vumc.org
615-875-3085

Study Officials

  • Zachary E Warren, PhD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 20, 2019

Study Start

March 4, 2019

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

November 29, 2022

Results First Posted

November 29, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)