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Can a Novel Telemedicine Tool Reduce Disparities Related to the Identification of Preschool Children With Autism? (TAP-P)

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ClinicalTrials.gov Identifier: NCT05373173
Recruitment Status : Not yet recruiting
First Posted : May 13, 2022
Last Update Posted : May 13, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Zachary Warren, Vanderbilt University Medical Center

Brief Summary:
Families seeking evaluation for autism spectrum disorder (ASD) often face barriers such as low availability of specialists, lengthy waitlists, and long distances to tertiary care diagnostic centers. This is especially true for children from traditionally underserved groups and communities. Without innovative approaches for enhanced identification of ASD, families and clinicians will continue to struggle with accessing and providing care. Telemedicine offers tremendous potential for addressing this need, but there are few psychometrically sound, validated tools that can be administered remotely, via telehealth platforms. This team of investigators developed and conducted a preliminary evaluation of a novel parent-administered, clinician-guided tele-diagnostic tool, the TAP (TELE-ASD-PEDS), designed specifically for direct-to-home and community clinic use with toddlers. Remote administration of the TAP yielded a very high level of agreement with blinded comprehensive evaluation regarding ASD risk classification. Subsequently, the unanticipated broad dissemination of the TAP during COVID-19 demonstrated its value for traditionally underserved groups, spanning broad geographies. Although promising, this work was limited by its specific focus on toddlers with ASD concerns. A telemedicine tool designed for the unique context and population of preschool-aged children referred for diagnostic assessment could have tremendous value in terms of both accurate identification as well as family engagement with service. In the current work, the investigators will now evaluate the performance, usability, and utility of the TAP-Preschool, a new telemedicine tool for ASD risk assessment in preschoolers, through a clinical trial. The TAP-Preschool was developed through a computationally informed co-production in which the targeted population were recruited as active partners in designing the tool. The investigators will gather critical data not only regarding its structure and accuracy, but also its potential deployment across systems responsible for engaging children and families from underserved groups in meaningful service. This work has potential to transform the ASD evaluation process and dramatically improve care access for traditionally underserved groups.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Tele-assessment + In-person assessment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Can a Novel Telemedicine Tool Reduce Disparities Related to the Identification of Preschool
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : December 15, 2024
Estimated Study Completion Date : December 15, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tele-assessment + In-person assessment
All families will receive an in-person tele-assessment appointment and an in-person evaluation.
Behavioral: Tele-assessment + In-person assessment
All consented families will complete an initial home-based tele-assessment visit via Zoom that includes the TAP-Preschool and a brief symptom-focused developmental interview with a consented clinician. The initial tele-assessment session includes interviewing and developmental assessment to mimic real-world use of TAP-Preschool. After the session, the examiner will record the clinical diagnosis issued (ASD, other developmental concerns, or typical development) and complete two diagnostic certainty ratings. All initial TAP-Preschool administrations will be recorded via Zoom, and 50% of administrations (randomly selected) will be co-scored by a blinded examiner, unaware of prior assessment results and diagnostic decision, to evaluate inter-rater reliability. Within 7 days of the remote assessment, families will participate in an in-person diagnostic assessment including common comprehensive measures of ASD, cognitive skills, and adaptive behavior.




Primary Outcome Measures :
  1. Positive Predictive Value (PPV) of the TAP-Preschool [ Time Frame: PPV will be calculated immediately after the last participant completes their in-person assessment ]
    Positive predictive value is the proportion of participants who screen at-risk for ASD on the TAP-Preschool that have a diagnosis of autism.

  2. Negative Predictive Value (NPV) of the TAP-Preschool [ Time Frame: NPV will be calculated immediately after the last participant completes their in-person assessment ]
    Negative predictive value is the proportion of the participants who do not screen at-risk for ASD on the TAP-Preschool who do not have a diagnosis of autism.

  3. Sensitivity of the TAP-Preschool [ Time Frame: Sensitivity will be calculated immediately after the last participant completes their in-person assessment ]
    Sensitivity will measure how often the TAP-Preschool correctly generated a positive result for participants who have autism.

  4. Specificity of the TAP-Preschool [ Time Frame: Specificity will be calculated immediately after the last participant completes their in-person assessment ]
    Specificity will measure the TAP-Preschool's ability to correctly generate a negative result for people who don't have a diagnosis of autism.

  5. Diagnostic Certainty: Tele-assessment [ Time Frame: Through study completion, an average of 2 years ]
    Immediately after completing the TAP-Preschool, clinicians will rate their diagnostic certainty in two ways: (1) on a 4-point Likert Scale from "Completely Uncertain" to "Completely Certain" and (2) on a dichotomous scale from "Certain" to "Uncertain"

  6. Family Satisfaction [ Time Frame: Through study completion, an average of 2 years ]
    Parents will complete the Parent Service Satisfaction survey to assess perceptions of tele-assessment procedures. The survey includes six questions with three response options per questions (Very True, Somewhat True, Not True)

  7. Diagnostic Certainty: In-person assessment [ Time Frame: Through study completion, an average of 2 years ]
    Immediately after completing the in-person assessment, clinicians will rate their diagnostic certainty in two ways: (1) on a 4-point Likert Scale from "Completely Uncertain" to "Completely Certain" and (2) on a dichotomous scale from "Certain" to "Uncertain"



Information from the National Library of Medicine

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Ages Eligible for Study:   36 Months to 72 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Initial deployment (n = 30):
  • English/Spanish Speaking families
  • Children 36-72 months of age
  • access to a device capable of supporting Zoom
  • already has participated in a diagnostic evaluation

Novel sample (n = 120):

Inclusion

  • English/Spanish Speaking families
  • Children 36-72 months of age
  • access to a device capable of supporting Zoom
  • has not participated in a diagnostic evaluation

Exclusion Criteria:

  • Initial deployment (n = 30):
  • severe sensorimotor impairments

Novel sample (n = 120):

- severe sensorimotor impairments


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05373173


Contacts
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Contact: Alison Vehorn, MS 615-343-8763 alison.vehorn@vumc.org
Contact: Liliana Wagner, PhD 615-936-5022 liliana.wagner@vumc.org

Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Zachary Warren, PhD Vanderbilt University Medical Center
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Responsible Party: Zachary Warren, Professor of Pediatrics; Director of the Division of Developmental Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT05373173    
Other Study ID Numbers: 220273
R21MH128790 ( U.S. NIH Grant/Contract )
First Posted: May 13, 2022    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zachary Warren, Vanderbilt University Medical Center:
Autism
ASD
Telehealth
Preschool
Tele-assessment
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders