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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03847337
Enrollment
144
Registered
2019-02-20
Start date
2019-03-04
Completion date
2021-09-30
Last updated
2022-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder, Developmental Delay

Keywords

telemedicine

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)

Interventions

OTHERTelehealth-Screening Tool for Autism in Toddlers (STAT)

Structured autism screening tool

OTHERTelehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)

Semi-structured autism screening tool

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Months to 3 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Accurate Diagnosis of Autism Via Telemedicine1 dayNumber of children who are accurately diagnosed with autism via diagnostic evaluation
Accurate Diagnosis of Developmental Delay Via Telemedicine1 dayNumber of children who are accurately diagnosed via diagnostic evaluation

Countries

United States

Participant flow

Participants by arm

ArmCount
ASD-PEDS
We will test the ASD-PEDS with children who have not been previously diagnosed with autism or developmental delay. Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS): Semi-structured autism screening tool
73
TELE-STAT
We will test the TELE-STAT with children who have not been previously diagnosed with autism or developmental delay. Telehealth-Screening Tool for Autism in Toddlers (STAT): Structured autism screening tool
71
Total144

Baseline characteristics

CharacteristicASD-PEDSTotalTELE-STAT
Age, Continuous2.57 years2.57 years2.58 years
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants10 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
56 Participants119 Participants63 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
10 Participants15 Participants5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Black or African American
7 Participants18 Participants11 Participants
Race (NIH/OMB)
More than one race
3 Participants12 Participants9 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants4 Participants1 Participants
Race (NIH/OMB)
White
59 Participants108 Participants49 Participants
Region of Enrollment
United States
73 participants144 participants71 participants
Sex: Female, Male
Female
26 Participants41 Participants15 Participants
Sex: Female, Male
Male
47 Participants103 Participants56 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 730 / 71
other
Total, other adverse events
0 / 730 / 71
serious
Total, serious adverse events
0 / 730 / 71

Outcome results

Primary

Accurate Diagnosis of Autism Via Telemedicine

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

Time frame: 1 day

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ASD-PEDSAccurate Diagnosis of Autism Via Telemedicine61 Participants
TELE-STATAccurate Diagnosis of Autism Via Telemedicine63 Participants
Primary

Accurate Diagnosis of Developmental Delay Via Telemedicine

Number of children who are accurately diagnosed via diagnostic evaluation

Time frame: 1 day

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ASD-PEDSAccurate Diagnosis of Developmental Delay Via Telemedicine7 Participants
TELE-STATAccurate Diagnosis of Developmental Delay Via Telemedicine2 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026