Autism Biomarker Consortium for Clinical Trials

NCT02996669 | Completed DMC

• 3 other identifiers: 1509016477U01FD006888U19MH108206
• Study Type: observational
• Target: 399
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter longitudinal study that aims to identify, develop and validate a set of measures that can be used as stratification biomarkers and/or sensitive and reliable objective measures of social impairment in autism spectrum disorders (ASD) that could serve as markers of long term clinical outcome. The main study will include 275 individuals: 200 ASD subjects between 6-11 years old, and 75 TD subjects roughly matched by age and sex to the ASD group.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (6)

• NEPSY-II

  NEPSY-II - Memory for Faces Subtest (administered to all ages): The NEPSY-II Memory for Faces subtest entails viewing a series of faces and having the child identify the sex of each face. The child is then shown three faces at a time and required to identify the previously seen face.

  Baseline

• NEPSY-II

  NEPSY-II - Memory for Faces Subtest (administered to all ages): The NEPSY-II Memory for Faces subtest entails viewing a series of faces and having the child identify the sex of each face. The child is then shown three faces at a time and required to identify the previously seen face.

  6 weeks

• NEPSY-II

  NEPSY-II - Memory for Faces Subtest (administered to all ages): The NEPSY-II Memory for Faces subtest entails viewing a series of faces and having the child identify the sex of each face. The child is then shown three faces at a time and required to identify the previously seen face.

  24 weeks

• Video Tracking

  Video tracking of social behavior is an observational method involving automated tracking of children's movements using the Noldus EthoVision Computerized tracking system. Using computer vision, video recordings of children's movements assess proximity-seeking/approach behaviors. During one six-minute free-play session in the laboratory, children's movements will be recorded from a ceiling-mounted camera and two side cameras while a parent sits in a corner of the room. Software automatically tracks the child (via the ceiling mounted camera) as the child plays with a standardized set of toys and interacts with the parent, and computes the percentage of session spent near the parentlatency to approach the parent, percentage of time spent in the periphery and latency to approach the periphery. A subset of side camera recordings will be manually coded by reliable coders for social engagement behaviors to validate the automatically generated movement behaviors calculated by EthoVision.

  Baseline

• Video Tracking

  Video tracking of social behavior is an observational method involving automated tracking of children's movements using the Noldus EthoVision Computerized tracking system. Using computer vision, video recordings of children's movements assess proximity-seeking/approach behaviors. During one six-minute free-play session in the laboratory, children's movements will be recorded from a ceiling-mounted camera and two side cameras while a parent sits in a corner of the room. Software automatically tracks the child (via the ceiling mounted camera) as the child plays with a standardized set of toys and interacts with the parent, and computes the percentage of session spent near the parentlatency to approach the parent, percentage of time spent in the periphery and latency to approach the periphery. A subset of side camera recordings will be manually coded by reliable coders for social engagement behaviors to validate the automatically generated movement behaviors calculated by EthoVision.

  6 weeks

• Video Tracking

  Video tracking of social behavior is an observational method involving automated tracking of children's movements using the Noldus EthoVision Computerized tracking system. Using computer vision, video recordings of children's movements assess proximity-seeking/approach behaviors. During one six-minute free-play session in the laboratory, children's movements will be recorded from a ceiling-mounted camera and two side cameras while a parent sits in a corner of the room. Software automatically tracks the child (via the ceiling mounted camera) as the child plays with a standardized set of toys and interacts with the parent, and computes the percentage of session spent near the parentlatency to approach the parent, percentage of time spent in the periphery and latency to approach the periphery. A subset of side camera recordings will be manually coded by reliable coders for social engagement behaviors to validate the automatically generated movement behaviors calculated by EthoVision.

  24 weeks

Secondary Outcomes (16)

• Aberrant Behavior Checklist (ABC)

  Baseline, 6 weeks and 24 weeks

• Autism Impact Measure (AIM) Frequency

  Baseline, 6 weeks and 24 weeks

• Autism Impact Measure (AIM) Impact

  Baseline, 6 weeks and 24 weeks

• Child and Adolescent Symptom Inventory 5 (CASI-5)

  Baseline, 6 weeks and 24 weeks

• PDD Behavior Inventory (PDD-BI)

  Baseline, 6 weeks and 24 weeks

Study Arms (2)

Autism Spectrum Disorder

During Screening Visits, the Autism Diagnostic Observational Schedule (ADOS) will be administered to confirm diagnosis. Criteria for group inclusion is: diagnosis of Autism Spectrum Disorder based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the Autism Diagnostic Observation Schedule (ADOS-G), and the Autism Diagnostic Interview-Revised, short form (ADI-R). Diagnostic evaluations will be completed by research staff and supervised by a licensed psychologist.

Typical Development

Typically Developing (TD) participants from each site will be roughly matched by age and sex to the ASD group.

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

200 children with an autism spectrum disorder between 6-11 years old, and 75 typically developing children

You may qualify if:

• For All Subjects:
• Males and Females Age 6 - 11 (\<11:5 at timepoint #1 unless all study procedures will be completed before the participant turns 12.0 and prior approval by the Principal Investigator is obtained).
• Written parental consent obtained prior to any study procedures.
• Participant and parent/guardian must be English speaking.
• For TD Participants:
• IQ 80-150 as assessed by the Differential Ability Scales (DAS)- 2nd Edition
• For ASD Participants:
• Diagnosis of ASD based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the Autism Diagnostic Observation Schedule (ADOS-2), and the Autism Diagnostic Interview-Revised, short form (ADI-R). Diagnostic evaluations will be completed by research staff and supervised by a licensed psychologist.
• IQ 60-150 as assessed by the Differential Ability Scales (DAS)- 2nd Edition

You may not qualify if:

• For All Subjects:
• Known genetic or neurological syndrome with established link to autism (in addition to ASD for ASD participants), but not events in which the link to ASD is less well known/established (e.g., 16p11.2 CNVs, CHD8 mutations, Trisomy 21, 22q deletion syndrome)
• History of epilepsy or seizure disorder (except for history of simple febrile seizures or if the child is seizure free (regardless of seizure type) for the past year).
• 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.
• History of significant prenatal/perinatal/birth injury (birth \<36 weeks AND weight \<2000 grams (approximately 4.5lbs)).
• History of neonatal brain damage. (e.g., with diagnoses hypoxic or ischemic event)
• Any other factor that the investigator feels would make assessment or measurement performance invalid.
• For ASD Participants:
• Any known environmental circumstances that is likely to account for the picture of autism in the proband (severe nutritional or psychological deprivation etc.)
• For TDs Participants:
• Known historical diagnosis of ASD or a sibling with ASD.
• Active psychiatric disorder (depression, anxiety, ADHD, etc.) and/or any current treatment (medication or other treatment) for a psychiatric condition. Participants will be screened using the Child/Adolescent Symptom Inventory (CASI-5). Due to the measurements sensitivity, any score in the clinical range will be reviewed by research staff for determination of eligibility.

Sponsors & Collaborators

• Yale University: lead
• Boston Children's Hospital: collaborator
• Duke University: collaborator
• University of California, Los Angeles: collaborator
• University of Washington: collaborator
• Food and Drug Administration (FDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Yale University Child Study Center

New Haven, Connecticut, United States

Location

Related Publications (2)

• Faja S, Sabatos-DeVito M, Sridhar A, Kuhn JL, Nikolaeva JI, Sugar CA, Webb SJ, Bernier RA, Sikich L, Hellemann G, Senturk D, Naples AJ, Shic F, Levin AR, Seow HA, Dziura JD, Jeste SS, Chawarska K, Nelson CA 3rd, Dawson G, McPartland JC; Autism Biomarkers Consortium for Clinical Trials. Evaluation of clinical assessments of social abilities for use in autism clinical trials by the autism biomarkers consortium for clinical trials. Autism Res. 2023 May;16(5):981-996. doi: 10.1002/aur.2905. Epub 2023 Mar 16.

  PMID: 36929131 DERIVED

• Shic F, Naples AJ, Barney EC, Chang SA, Li B, McAllister T, Kim M, Dommer KJ, Hasselmo S, Atyabi A, Wang Q, Helleman G, Levin AR, Seow H, Bernier R, Charwaska K, Dawson G, Dziura J, Faja S, Jeste SS, Johnson SP, Murias M, Nelson CA, Sabatos-DeVito M, Senturk D, Sugar CA, Webb SJ, McPartland JC. The autism biomarkers consortium for clinical trials: evaluation of a battery of candidate eye-tracking biomarkers for use in autism clinical trials. Mol Autism. 2022 Mar 21;13(1):15. doi: 10.1186/s13229-021-00482-2.

  PMID: 35313957 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• James McPartland, PhD

  Yale University Child Study Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: December 19, 2016
• Study Start: October 1, 2016
• Primary Completion: May 13, 2019
• Study Completion: May 13, 2019
• Last Updated: March 5, 2020

Record last verified: 2020-03

Locations

US (1)