Autism Spectrum Disorder, Developmental Delay
Conditions
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
Structured autism screening tool
Semi-structured autism screening tool
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Accurate Diagnosis of Autism Via Telemedicine | 1 day | Number of children who are accurately diagnosed with autism via diagnostic evaluation |
| Accurate Diagnosis of Developmental Delay Via Telemedicine | 1 day | Number of children who are accurately diagnosed via diagnostic evaluation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 144 |
Baseline characteristics
| Characteristic | ASD-PEDS | Total | TELE-STAT |
|---|---|---|---|
| Age, Continuous | 2.57 years | 2.57 years | 2.58 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 10 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 119 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 15 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 18 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 12 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 59 Participants | 108 Participants | 49 Participants |
| Region of Enrollment United States | 73 participants | 144 participants | 71 participants |
| Sex: Female, Male Female | 26 Participants | 41 Participants | 15 Participants |
| Sex: Female, Male Male | 47 Participants | 103 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 73 | 0 / 71 |
| other Total, other adverse events | 0 / 73 | 0 / 71 |
| serious Total, serious adverse events | 0 / 73 | 0 / 71 |
Outcome results
Accurate Diagnosis of Autism Via Telemedicine
Number of children who are accurately diagnosed with autism via diagnostic evaluation
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ASD-PEDS | Accurate Diagnosis of Autism Via Telemedicine | 61 Participants |
| TELE-STAT | Accurate Diagnosis of Autism Via Telemedicine | 63 Participants |
Accurate Diagnosis of Developmental Delay Via Telemedicine
Number of children who are accurately diagnosed via diagnostic evaluation
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ASD-PEDS | Accurate Diagnosis of Developmental Delay Via Telemedicine | 7 Participants |
| TELE-STAT | Accurate Diagnosis of Developmental Delay Via Telemedicine | 2 Participants |