Trial Outcomes & Findings for Can Novel Telemedicine Tools Reduce Disparities Related to Early Identification of Autism (NCT NCT03847337)

NCT ID: NCT03847337

Last Updated: 2022-11-29

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

144 participants

Primary outcome timeframe

1 day

Results posted on

2022-11-29

Participant Flow

Participant milestones

Participant milestones
Measure
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
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
Overall Study
STARTED
73
71
Overall Study
COMPLETED
73
71
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ASD-PEDS
n=73 Participants
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
TELE-STAT
n=71 Participants
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
Total
n=144 Participants
Total of all reporting groups
Age, Continuous
2.57 years
n=93 Participants
2.58 years
n=4 Participants
2.57 years
n=27 Participants
Sex: Female, Male
Female
26 Participants
n=93 Participants
15 Participants
n=4 Participants
41 Participants
n=27 Participants
Sex: Female, Male
Male
47 Participants
n=93 Participants
56 Participants
n=4 Participants
103 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
n=93 Participants
3 Participants
n=4 Participants
10 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
56 Participants
n=93 Participants
63 Participants
n=4 Participants
119 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
10 Participants
n=93 Participants
5 Participants
n=4 Participants
15 Participants
n=27 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Asian
1 Participants
n=93 Participants
1 Participants
n=4 Participants
2 Participants
n=27 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Black or African American
7 Participants
n=93 Participants
11 Participants
n=4 Participants
18 Participants
n=27 Participants
Race (NIH/OMB)
White
59 Participants
n=93 Participants
49 Participants
n=4 Participants
108 Participants
n=27 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=93 Participants
9 Participants
n=4 Participants
12 Participants
n=27 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=93 Participants
1 Participants
n=4 Participants
4 Participants
n=27 Participants
Region of Enrollment
United States
73 participants
n=93 Participants
71 participants
n=4 Participants
144 participants
n=27 Participants

PRIMARY outcome

Timeframe: 1 day

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

Outcome measures

Outcome measures
Measure
ASD-PEDS
n=73 Participants
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
TELE-STAT
n=71 Participants
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
Accurate Diagnosis of Autism Via Telemedicine
61 Participants
63 Participants

PRIMARY outcome

Timeframe: 1 day

Number of children who are accurately diagnosed via diagnostic evaluation

Outcome measures

Outcome measures
Measure
ASD-PEDS
n=73 Participants
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
TELE-STAT
n=71 Participants
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
Accurate Diagnosis of Developmental Delay Via Telemedicine
7 Participants
2 Participants

Adverse Events

ASD-PEDS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

TELE-STAT

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zachary Warren

Vanderbilt University Medical Center

Phone: 615-875-3085

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place