RECRUITING

SenseToKnow Autism Screening Device Validation Study

Talk to us

Conditions

AutismAutism Spectrum DisorderDiagnosisDigital device

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow app for the detection of autism spectrum disorder in children 16-36 months of age.

Official Title

SenseToKnow STAR Study: A Study of Technologies for Assessing Children's Development

Quick Facts

Study Start:2023-07-07
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05874466

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Months to 36 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Duke Health pediatric patient at enrollment
  2. 2. 16-\<37 months of age at enrollment
  3. 3. Parent/legal guardian speaks English or Spanish
  4. 4. Parent/legal guardian understands and voluntarily provides informed consent
  1. 1. Severe motor impairment that precludes study measure completion
  2. 2. Known genetic disorders
  3. 3. Severe hearing or visual impairment as determined on physical examination according to parent report
  4. 4. Acute illnesses likely to prevent successful or valid data collection
  5. 5. Uncontrolled epilepsy or seizure disorder
  6. 6. History or presence of a clinically significant medical disease, or a mental state that could confound the study or be detrimental to the subject as determined by the investigator
  7. 7. Acute exacerbations of chronic illnesses likely to prevent successful or valid data collection
  8. 8. Receiving therapies that affect vision
  9. 9. Parent/legal guardian and/or investigator believes that the child will be unable/unwilling to sit in the parent's lap to watch the app videos
  10. 10. Parent/legal guardian indicates that they or their child is unwilling or unable to complete the app administration, surveys, or diagnostic assessment
  11. 11. Participants who are otherwise judged as unable to comply with the protocol by the investigator
  12. 12. Any other factor that the investigator feels would make the study measures invalid

Contacts and Locations

Study Contact

Geraldine Dawson, PhD
CONTACT
9196680070
geraldine.dawson@duke.edu
Charlotte Stoute, BA
CONTACT
919-681-9730
charlotte.stoute@duke.edu

Principal Investigator

Geraldine Dawson, PhD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Duke University

  • Geraldine Dawson, PhD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-07
Study Completion Date2028-08

Study Record Updates

Study Start Date2023-07-07
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • Diagnosis
  • Digital device

Additional Relevant MeSH Terms

  • Autism
  • Autism Spectrum Disorder