COMPLETED

The Autism Biomarkers Consortium for Clinical Trials: Confirmation Study

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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 longitudinal study that aims to validate a set of measures that were previously identified as promising candidate biomarkers and/or sensitive and reliable objective measures of social function in ASD for potential use in clinical trials. The confirmation study will repeat the data collection and analysis protocols from the original ABC-CT study. This confirmation study will recruit 200 ASD and 200 TD comparison participants who are 6-11 years old, matching the overall sample size but providing a larger normative reference sample and greater statistical power for group comparisons.

Official Title

The Autism Biomarkers Consortium for Clinical Trials

Quick Facts

Study Start:2022-04-11

Study Completion:2025-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05294705

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:6 Years to 11 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Males and Females Age 6 - 11 (less than 11 years and 6 months old at T1D1 unless all study procedures will be completed before the participant turns 12.0 and prior approval by the Principal Investigator is obtained). 2. Written parental permission, and child assents when applicable, obtained prior to any study procedures. 3. IQ 60-150 (ASD) and 80-150 (TD) as assessed by the Differential Ability Scales - 2nd Edition. 4. Participant and parent/guardian must be English speaking. 1. Diagnosis of ASD based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the Autism Diagnostic Observation Schedule (ADOS-2) or BOSA and the Autism Diagnostic Interview-Revised, short form (ADI-R). Diagnostic evaluations will be completed by research staff and supervised by a licensed psychologist. 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. Known genetic or neurological syndrome with an established link to autism (in addition to ASD for ASD participants) 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). 2. Specific cases will be discussed with the clinical team who will make a final determination, as needed. 2. History of epilepsy or seizure disorder 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. 4. Children who are taking neurological or psychiatric medications that are not stable on prescription or dose for 8 weeks prior to T1D1. 5. History of significant prenatal/perinatal/birth injury as defined by birth \<36 weeks AND weight \<2000 grams (approximately 4.5.lbs). 6. History of neonatal brain damage. (e.g., with diagnosed hypoxic or ischemic event). 7. Any other factor that the investigator feels would make assessment or measurement performance invalid. 8. Participation in the original ABC-CT study. 1. Known historical diagnosis of ASD or a sibling with ASD. 2. Criteria score in the ASD range on the ADOS/BOSA at T1 3. Active psychiatric disorder (depression, anxiety, ADHD, etc.) and/or any current treatment (medication or other treatment) for a psychiatric condition. 1. Participants will be screened using the Child/Adolescent Symptom Inventory (CASI- 5). 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.

Inclusion Criteria

Exclusion Criteria

1. Males and Females Age 6 - 11 (less than 11 years and 6 months old at T1D1 unless all study procedures will be completed before the participant turns 12.0 and prior approval by the Principal Investigator is obtained).
2. Written parental permission, and child assents when applicable, obtained prior to any study procedures.
3. IQ 60-150 (ASD) and 80-150 (TD) as assessed by the Differential Ability Scales - 2nd Edition.
4. Participant and parent/guardian must be English speaking.
1. Diagnosis of ASD based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the Autism Diagnostic Observation Schedule (ADOS-2) or BOSA and the Autism Diagnostic Interview-Revised, short form (ADI-R). Diagnostic evaluations will be completed by research staff and supervised by a licensed psychologist.
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. Known genetic or neurological syndrome with an established link to autism (in addition to ASD for ASD participants)
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).
2. Specific cases will be discussed with the clinical team who will make a final determination, as needed.
2. History of epilepsy or seizure disorder
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.
4. Children who are taking neurological or psychiatric medications that are not stable on prescription or dose for 8 weeks prior to T1D1.
5. History of significant prenatal/perinatal/birth injury as defined by birth \<36 weeks AND weight \<2000 grams (approximately 4.5.lbs).
6. History of neonatal brain damage. (e.g., with diagnosed hypoxic or ischemic event).
7. Any other factor that the investigator feels would make assessment or measurement performance invalid.
8. Participation in the original ABC-CT study.
1. Known historical diagnosis of ASD or a sibling with ASD.
2. Criteria score in the ASD range on the ADOS/BOSA at T1
3. Active psychiatric disorder (depression, anxiety, ADHD, etc.) and/or any current treatment (medication or other treatment) for a psychiatric condition.
1. Participants will be screened using the Child/Adolescent Symptom Inventory (CASI- 5). 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, 06519

United States

Boston Children's Hospital

Boston, Massachusetts, 02445

United States

Duke

Durham, North Carolina, 27708

United States

Unviersity of Washington

Seattle, Washington, 98105

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 Date2022-04-11

Study Completion Date2025-08-31

Study Record Updates

Study Start Date2022-04-11

Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

Biomarkers

Additional Relevant MeSH Terms

Autism Spectrum Disorder