Autism Spectrum DisorderNCT03847337
Can Novel Telemedicine Tools Reduce Disparities Related to Early Identification of Autism
A study testing Telehealth-Screening Tool for Autism in Toddlers (STAT) and Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS) in people with Autism Spectrum Disorder and Developmental Delay, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 months to 3 years
- Conditions the study is for
- Autism Spectrum Disorder, Developmental Delay
- What is being tested?
- Telehealth-Screening Tool for Autism in Toddlers (STAT) and Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who have been diagnosed with autism or developmental delay
Who cannot join
- Children with genetic disorders
- Children with medical complexities, such as blindness or deafness
- Children whose families do not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
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.
Read the 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)
- Conditions
- Autism Spectrum Disorder, Developmental Delay
- Being tested
- Telehealth-Screening Tool for Autism in Toddlers (STAT), Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)
- Keywords
- telemedicine
- Medical subject headings
- Autism Spectrum Disorder, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth-Screening Tool for Autism in Toddlers (STAT)Other
Structured autism screening tool
Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)Other
Semi-structured autism screening tool
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Telehealth-Screening Tool for Autism in Toddlers (STAT); Other: Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate Diagnosis of Autism Via Telemedicine
Number of children who are accurately diagnosed with autism via diagnostic evaluation
Measured: 1 day
Accurate Diagnosis of Developmental Delay Via Telemedicine
Number of children who are accurately diagnosed via diagnostic evaluation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start4 Mar 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Zachary Warren, Vanderbilt University Medical Center
- Investigators
- Zachary E Warren, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847337
- Sponsor's protocol ID
- 190152
- Other IDs
- 1R21MH118539-01
- Status last verified
- Oct 2022
- First submitted
- 18 Feb 2019
- Last updated
- 29 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hodge A, Sutherland R, Ong N, Chan E, Barnett D, Bennett B, Boulton K, Francis D, Guastella A, Papanicolaou A, Tomsic G, Williamsz M, Silove N. Telehealth assessment of autism in preschoolers using the TELE-ASD-PEDS: A pilot clinical investigation. Int J Speech Lang Pathol. 2024 Dec;26(6):767-783. doi: 10.1080/17549507.2023.2270187. Epub 2023 Dec 18.
PubMed 38105699
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Novel Telemedicine Tools Reduce Disparities Related to Early Identification of Autism
- ClinicalTrials.gov ID
- NCT03847337
- Acronym / sponsor ID
- 190152
- Conditions
- Autism Spectrum Disorder, Developmental Delay
- Keywords
- telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Posted 29 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New to diagnosis | Experimental | Other: Telehealth-Screening Tool for Autism in Toddlers (STAT), Other: Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)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). |
| Previously diagnosed | Experimental | Other: Telehealth-Screening Tool for Autism in Toddlers (STAT), Other: Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)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). |
Who may qualify
- Ages
- 15 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children who have been diagnosed with autism or developmental delay
Key exclusion criteria (3 listed)
- Children with genetic disorders
- Children with medical complexities, such as blindness or deafness
- Children whose families do not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth-Screening Tool for Autism in Toddlers (STAT)Structured autism screening tool | Other | New to diagnosis, Previously diagnosed |
| Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)Semi-structured autism screening tool | Other | New to diagnosis, Previously diagnosed |
Primary outcome
Accurate Diagnosis of Autism Via Telemedicine
Time frame: 1 day
Number of children who are accurately diagnosed with autism via diagnostic evaluation
Accurate Diagnosis of Developmental Delay Via Telemedicine
Time frame: 1 day
Number of children who are accurately diagnosed via diagnostic evaluation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38105699Hodge A, Sutherland R, Ong N, Chan E, Barnett D, Bennett B, Boulton K, Francis D, Guastella A, Papanicolaou A, Tomsic G, Williamsz M, Silove N. Telehealth assessment of autism in preschoolers using the TELE-ASD-PEDS: A pilot clinical investigation. Int J Speech Lang Pathol. 2024 Dec;26(6):767-783. doi: 10.1080/17549507.2023.2270187. Epub 2023 Dec 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zachary E Warren, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth-Screening Tool for Autism in Toddlers (STAT) and Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS) in people with Autism Spectrum Disorder and Developmental Delay, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurate Diagnosis of Autism Via Telemedicine (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03847337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.