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Telemedicine Assessment for Autism (TAP-P Trial)
N/A
Recruiting
Led By Zachary Warren, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Novel sample (n = 120): English/Spanish Speaking families with children 36-72 months of age, access to a device capable of supporting Zoom, and has not participated in a diagnostic evaluation
Be younger than 18 years old
Must not have
Initial deployment (n = 30): Severe sensorimotor impairments
Novel sample (n = 120): Severe sensorimotor impairments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
Summary
This trialis developing a telemedicine tool to improve access to ASD diagnosis for underserved groups, such as those with long waitlists or long distances to care.
Who is the study for?
This trial is for preschool children aged 36-72 months who may have autism. It's open to English or Spanish-speaking families with access to a device that supports Zoom. The study includes kids both previously evaluated for autism and those not yet assessed.Check my eligibility
What is being tested?
The trial is testing the TAP-Preschool, a new telemedicine tool designed to assess the risk of autism in preschoolers remotely. It compares results from this tool with traditional in-person assessments to see if it can improve care access.See study design
What are the potential side effects?
Since this trial involves assessment tools rather than medication, there are no direct physical side effects expected. However, participating families might experience stress or anxiety related to the use of technology and concerns about their child's development.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I speak English or Spanish, have a child aged 3-6, can use Zoom, and haven't had a diagnostic evaluation.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe difficulties in feeling or moving parts of my body.
Select...
I have severe difficulties with movement and sensation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diagnostic Certainty: In-person assessment
Diagnostic Certainty: Tele-assessment
Family Satisfaction
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Tele-assessment + In-person assessmentExperimental Treatment1 Intervention
All families will receive an in-person tele-assessment appointment and an in-person evaluation.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
869 Previous Clinical Trials
678,474 Total Patients Enrolled
15 Trials studying Autism Spectrum Disorder
2,360 Patients Enrolled for Autism Spectrum Disorder
National Institute of Mental Health (NIMH)NIH
2,820 Previous Clinical Trials
2,692,669 Total Patients Enrolled
82 Trials studying Autism Spectrum Disorder
40,252 Patients Enrolled for Autism Spectrum Disorder
Zachary Warren, PhDPrincipal InvestigatorVanderbilt University Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe difficulties in feeling or moving parts of my body.I have severe difficulties with movement and sensation.My family speaks English or Spanish, has a child aged 3-6, can use Zoom, and we've had a diagnostic evaluation.I speak English or Spanish, have a child aged 3-6, can use Zoom, and haven't had a diagnostic evaluation.
Research Study Groups:
This trial has the following groups:- Group 1: Tele-assessment + In-person assessment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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