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ABC-CT Pre-School Feasibility Study

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Conditions

Autism Spectrum DisorderBiomarker

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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 multicenter study that aims to determine whether the EEG and ET experiments studied in the ABC-CT Phase 1 and ABC-CT Confirmation studies can be successfully used with 3-5-year-old children and to determine the viability of these measures as potential biomarkers in 3-5-year-old children with ASD. Blood (DNA) samples will be collected from participants with ASD and biological parents for future genomic analyses, and raw, processed, and analyzed data will be shared to create a community resource accessible for use by all qualified investigators. These objectives are designed to advance the long term objective of developing promising biomarkers via the FDA Biomarker Qualification Program. This feasibility study aims to enroll 25 ASD and 25 TD eligible participants who are 3-5 years old.

Official Title

Autism Biomarkers Consortium for Clinical Trials (ABC-CT) Pre-School Feasibility Study

Quick Facts

Study Start:2024-07-02
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06413316

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:3 Years to 5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Children (regardless of biological sex) Age 3 - 5. Participants must be able to complete the study before turning 6.
  2. 2. Written parental permission will be obtained prior to any study procedures. Child verbal assent will be obtained.
  3. 3. IQ 60-150 (ASD) and 80-150 (TD) as assessed by the Differential Ability Scales - 2nd Edition or developmental level via Mullen Scales of Early Learning Composite (ELC).
  4. 4. Participant and parent/guardian must be English speaking.
  5. 1. Diagnosis of ASD based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the BOSA or Autism Diagnostic Observation Schedule (ADOS-2) and short form (ADI-R) scored age appropriately. Diagnostic evaluations will be completed by research staff and supervised by a licensed psychologist.
  6. 2. If parents are biological, a minimum of the child and one parent will be required to consent to the blood draw procedure. It is preferred that the child and both biological parents participate in the blood draw procedure. The inability to obtain blood samples will not be exclusionary.
  1. 1. Known genetic or neurological syndrome with an established link to autism (in addition to ASD for ASD participants)
  2. 1. This does not include events in which the link to ASD is less well known/established (e.g., 16p11.2 CNVs, CHD8 mutations, Trisomy 21, 22q deletion syndrome, Dup 15q Syndrome).
  3. 2. Specific cases will be discussed with the clinical team who will make a final determination, as needed.
  4. 2. History of epilepsy or seizure disorder
  5. 3. Motor or sensory impairment that would interfere with the valid completion of study measures including significant hearing or vision impairment not correctable by a hearing aid or glasses/contact lenses. Children who wear bifocal or progressive lenses are not eligible.
  6. 4. Children who are taking neurological or psychiatric medications that are not stable on prescription or dose for 8 weeks prior to D1.
  7. 5. History of significant prenatal/perinatal/birth injury as defined by birth \<36 weeks AND weight \<2000 grams (approximately 4.5.lbs).
  8. 6. History of neonatal brain damage. (e.g., with diagnosed hypoxic or ischemic event).
  9. 7. Any other factor that the investigator feels would make assessment or measurement performance invalid.
  10. 1. Any known environmental circumstances that is likely to account for the picture of autism in the proband (severe nutritional or psychological deprivation etc.)
  11. 1. Known historical diagnosis of ASD or a sibling with ASD.
  12. 2. Criteria score in the ASD range on the BOSA/ADOS
  13. 3. Active psychiatric disorder (depression, anxiety, ADHD, etc.) and/or any current treatment (medication or other treatment) for a psychiatric condition.
  14. 1. Participants will be screened using the (ECI-5 or CSI-4). Due to the instrument's high sensitivity and potential for false positives, any score in the clinical range will be reviewed by research staff for determination of eligibility.

Contacts and Locations

Principal Investigator

James McPartland, PhD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Yale Child Study Center
New Haven, Connecticut, 06510
United States
Boston Children's Hospital
Boston, Massachusetts, 02445
United States
Duke University
Durham, North Carolina, 27708
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Yale University

  • James McPartland, PhD, PRINCIPAL_INVESTIGATOR, Yale 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 Date2024-07-02
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2024-07-02
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • Biomarker

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder