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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21MH118539-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth-Screening Tool for Autism in Toddlers (STAT) | Other | Structured autism screening tool |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zachary E Warren, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | TELE-STAT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2019 |
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| Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS) | Other | Semi-structured autism screening tool |
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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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accurate Diagnosis of Autism Via Telemedicine | Number of children who are accurately diagnosed with autism via diagnostic evaluation | Posted | Count of Participants | Participants | 1 day |
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| Primary | Accurate Diagnosis of Developmental Delay Via Telemedicine | Number of children who are accurately diagnosed via diagnostic evaluation | Posted | Count of Participants | Participants | 1 day |
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Day of assessment
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 73 | 0 | 73 | 0 | 73 |
| EG001 | 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 | 0 | 71 | 0 | 71 | 0 | 71 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zachary Warren | Vanderbilt University Medical Center | 615-875-3085 | zachary.e.warren@vumc.org |
| Oct 31, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 4, 2019 | Oct 31, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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