Autism Spectrum DisorderABC-CTNCT02996669
Autism Biomarker Consortium for Clinical Trials
An observational study of Autism Spectrum Disorder, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 399 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 13 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 200 children with an autism spectrum disorder between 6-11 years old, and 75 typically developing children
Who may be able to join
- 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
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- 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
- If parents are biological, a minimum of the child and one parent (if accompanying the child at study visits) will be required to participate in the blood draw procedure. It is preferred that the child and both biological parents participate in the blood draw procedure, but the inability to obtain blood samples from trios will not be exclusionary.
Who cannot join
- 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.
- Medication is not exclusionary. Children taking neurological or psychiatric medications, including anti epileptics and psychopharmacological agents, must be stable on the medication and dose for 8 weeks prior to T1D1.
- History of significant prenatal/perinatal/birth injury (birth <36 weeks AND weight <2000 grams (approximately 4.5lbs)).
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University Child Study Center
New Haven, Connecticut
About this study
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.
Read the detailed description
The specified aims of this study are to accelerate the development of effective treatments for social impairment in ASD by validating outcome measures that will be sensitive and reliable assessments of response to treatment and electroencephalography (EEG) and eye-tracking (ET) biomarkers. These hypothesized outcomes could then be used to reduce the heterogeneity of samples via stratification, could possibly indicate early efficacy, and/or demonstrate target engagement. The consortium will conduct a naturalistic, longitudinal study of preschool and school-aged (6-11 years) children with ASD and typical development (TD) with intelligence quotient(s) (IQ) ranging from 50-150. Children will be assessed across three time points (Baseline, 6 weeks and 24 weeks) using clinician, caregiver and lab-based (LB) measures of social impairment, along with a battery of conceptually related EEG and ET tasks and independent ratings of clinical status.
- Conditions
- Autism Spectrum Disorder
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Secondary outcomes (16)
Aberrant Behavior Checklist (ABC)
The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors of children and adults with neurodevelopmetnal disorder at home, in residential facilities, ICFs/MR, and work training centers. It is also useful for classifying problem behaviors of children and adolescents with neurodevelopmetnal disorder in educational settings, residential and community-based facilities, and developmental centers.
Aman MG, Singh NN, Stewart AW, Field CJ. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects. Am J Ment Defic. 1985; 89(5):485-491.
Measured: Baseline, 6 weeks and 24 weeks
Autism Impact Measure (AIM) Frequency
The Autism Impact Measure (AIM) uses a 2-week recall period with items rated on two corresponding 5-point scales (frequency and impact). PMID: 23748386.
Measured: Baseline, 6 weeks and 24 weeks
Autism Impact Measure (AIM) Impact
The Autism Impact Measure (AIM) uses a 2-week recall period with items rated on two corresponding 5-point scales (frequency and impact). PMID: 23748386.
Measured: Baseline, 6 weeks and 24 weeks
Child and Adolescent Symptom Inventory 5 (CASI-5)
The Child \& Adolescent Symptom Inventory-5 (CASI-5) is a behavior rating scale for DSM-5-defined emotional and behavioral disorders in youths between 5 and 18 years old.
Measured: Baseline, 6 weeks and 24 weeks
PDD Behavior Inventory (PDD-BI)
The PDD-BI is an assessment tool for children on the autism spectrum. PDDBI profiles can provide guidance to clinicians regarding the child's problems as perceived by the informants, how a particular child compares to most children their age with ASD, and the skills and abilities of the child.
Cohen, I. L. (2003). Criterion-related validity of the PDD Behavior Inventory. Journal of Autism and Developmental Disorders, 33, 47-53.
Measured: Baseline, 6 weeks and 24 weeks
Social Responsiveness Scale 2 (SRS-2) Total Score
The Social Responsiveness Scale 2 (SRS-2) is completed in just 15 to 20 minutes and identifies social impairment associated with autism spectrum disorders (ASDs) and quantifies its severity.
Measured: Baseline, 6 weeks and 24 weeks
Cognitive Assessment
Differential Ability Scales - Second Edition; DAS-II (Elliott C, 2007): The DAS-II is a clinical instrument designed to assess cognitive ability include variables such as verbal cluster, spatial cluster, nonverbal cluster, special nonverbal composite and GCA. The overall score will be used.
Measured: Baseline and 24 weeks
Resting State EEG
Resting State EEG (Eyes Open) provides a reference for the event-related EEG measures and a baseline biomarker of EEG spectral power across frequencies, neurofunctional connectivity and coherence, and hemispheric asymmetry and will always be done prior to the other EEG paradigms. Participants will be presented with non-social, abstract moving videos in random order.
Measured: Baseline, 6 weeks and 24 weeks
Faces EEG
Faces processing is a foundation for social perception and attention and serves as a promising and robust biomarker of social impairment in ASD and a potential index of subgroup differences. As the primary non-resting paradigm, the FACES task will always be administered second in the EEG protocol. Participants will be presented with a series of upright and inverted faces, as well as upright houses (as a contrast non-face stimulus).
Measured: Baseline, 6 weeks and 24 weeks
Visual Evoked Potentials (VEPs) EEG
Visual Evoked Potentials (VEPs) index low-level visual processing and reflect the functional integrity of the visual pathway. VEPs reflect excitatory (glutamatergic) and inhibitory (GABAergic) activity and may index subgroups of ASD with low-level visual impairments. VEPs also serve as a control for assessment of higher-order activity in social visual paradigms. Subjects will be presented with black and white checkerboards that reverse phase at a defined interval. The order of the VEP and Biomotion paradigms will be counterbalanced.
Measured: Baseline, 6 weeks and 24 weeks
Biological Motion EEG
Biological Motion processed by specific neural circuitry, which has demonstrated to exhibit reduced sensitivity in ASD. Point light displays (PLDs) of a human walking versus scrambled motion will be presented randomly. The order of the VEP and Biomotion paradigms will be counterbalanced.
Measured: Baseline, 6 weeks and 24 weeks
Eye-tracking (ET) Biological Motion Task
ET Paradigms will be administered in counterbalanced blocks, one on each day of each screening or study visits. Both blocks will include all the tasks but in different orders. The length of individual paradigms ranges from 1 to 8.5 mins.
Biological Motion Task is measured after short central fixation, children will be presented with Point Light Displays (PLDs) indicating target biological motion and a scrambled or a rotating perceptual control.
Measured: Baseline, 6 weeks and 24 weeks
Eye-tracking (ET) Activity Monitoring Task
ET Paradigms will be administered in counterbalanced blocks, one on each day of each screening or study visits. Both blocks will include all the tasks but in different orders. The length of individual paradigms ranges from 1 to 8.5 mins.
Activity Monitoring Task is measured following central fixation. Children will be presented with multiple activity monitoring trails depicting two actresses engaging in a controlled joint activity such as assembling a puzzle.
Measured: Baseline, 6 weeks and 24 weeks
Eye-tracking (ET) Interactive Social Task (IST)
ET Paradigms will be administered in counterbalanced blocks, one on each day of each screening or study visits. Both blocks will include all the tasks but in different orders. The length of individual paradigms ranges from 1 to 8.5 mins.
Interactive Social Task (IST) is taps similar constructs as the activity monitoring task in a more naturalistic, dynamic, and complex context. Following a central fixation, children will be presented with interactive social trails in which two children engage in a natural interactive play session.
Measured: Baseline, 6 weeks and 24 weeks
Eye-tracking (ET) Pupillary Light Reflex Task
ET Paradigms will be administered in counterbalanced blocks, one on each day of each screening or study visits. Both blocks will include all the tasks but in different orders. The length of individual paradigms ranges from 1 to 8.5 mins.
Pupillary Light Reflex (PLR) Task is measured following a stimuli that consist of a central fixation point on a black background that flashes white for 133 milliseconds. The constriction of the pupil in response to a bright flash indexes function of the parasympathetic nervous system.
Measured: Baseline, 6 weeks and 24 weeks
Eye-tracking (ET) Visual Search/Static Social Scenes Task
ET Paradigms will be administered in counterbalanced blocks, one on each day of each screening or study visits. Both blocks will include all the tasks but in different orders. The length of individual paradigms ranges from 1 to 8.5 mins.
Color images depicting 12 different female faces with direct gaze and the same faces with averted gaze will be presented. Twelve different exemplars from each of five categories (alarm clocks, mobile phones, birds, cars, and shoes) will be used as distracters. Twelve different slides will each contain six images (one face and five distracters, one from each category) placed at an equal distance from the center of the screen. Each slide contains a different set of six images, each image being shown only once in the experiment. This measure examines scanning patterns towards arrays of objects, synthetic stimuli, and faces as well as towards more complex naturalistic (static) scenes. This task examines complex scene processing and attentional select
Measured: Baseline, 6 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startOct 2016
- Primary completion13 May 2019
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, Duke University, University of California, Los Angeles, University of Washington, Food and Drug Administration (FDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- James McPartland, PhD, Principal investigator, Yale University Child Study Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996669
- Sponsor's protocol ID
- 1509016477
- Other IDs
- U01FD006888, U19MH108206
- Acronym
- ABC-CT
- Status last verified
- Mar 2020
- First submitted
- 21 Oct 2015
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36929131Shic 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.
PubMed 35313957
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Biomarker Consortium for Clinical Trials
- ClinicalTrials.gov ID
- NCT02996669
- Acronym / sponsor ID
- ABC-CT / 1509016477
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, Duke University, University of California, Los Angeles, University of Washington, Food and Drug Administration (FDA), National Institute of Mental Health (NIMH)
- Study start
- Oct 2016
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The specified aims of this study are to accelerate the development of effective treatments for social impairment in ASD by validating outcome measures that will be sensitive and reliable assessments of response to treatment and electroencephalography (EEG) and eye-tracking (ET) biomarkers. These hypothesized outcomes could then be used to reduce the heterogeneity of samples via stratification, could possibly indicate early efficacy, and/or demonstrate target engagement. The consortium will conduct a naturalistic, longitudinal study of preschool and school-aged (6-11 years) children with ASD and typical development (TD) with intelligence quotient(s) (IQ) ranging from 50-150. Children will be assessed across three time points (Baseline, 6 weeks and 24 weeks) using clinician, caregiver and lab-based (LB) measures of social impairment, along with a battery of conceptually related EEG and ET tasks and independent ratings of clinical status.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 200 children with an autism spectrum disorder between 6-11 years old, and 75 typically developing children
Key inclusion criteria (10 listed)
- 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.
- IQ 80-150 as assessed by the Differential Ability Scales (DAS)- 2nd Edition
- 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.
Key exclusion criteria (13 listed)
- 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.
- Medication is not exclusionary. Children taking neurological or psychiatric medications, including anti epileptics and psychopharmacological agents, must be stable on the medication and dose for 8 weeks prior to T1D1.
- History of significant prenatal/perinatal/birth injury (birth <36 weeks AND weight <2000 grams (approximately 4.5lbs)).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NEPSY-II
Time frame: Baseline
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.
NEPSY-II
Time frame: 6 weeks
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.
NEPSY-II
Time frame: 24 weeks
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.
Video Tracking
Time frame: Baseline
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.
Video Tracking
Time frame: 6 weeks
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.
Video Tracking
Time frame: 24 weeks
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.
16 secondary outcomes
Aberrant Behavior Checklist (ABC)
Time frame: Baseline, 6 weeks and 24 weeks
Autism Impact Measure (AIM) Frequency
Time frame: Baseline, 6 weeks and 24 weeks
Autism Impact Measure (AIM) Impact
Time frame: Baseline, 6 weeks and 24 weeks
Child and Adolescent Symptom Inventory 5 (CASI-5)
Time frame: Baseline, 6 weeks and 24 weeks
PDD Behavior Inventory (PDD-BI)
Time frame: Baseline, 6 weeks and 24 weeks
Social Responsiveness Scale 2 (SRS-2) Total Score
Time frame: Baseline, 6 weeks and 24 weeks
Cognitive Assessment
Time frame: Baseline and 24 weeks
Resting State EEG
Time frame: Baseline, 6 weeks and 24 weeks
Faces EEG
Time frame: Baseline, 6 weeks and 24 weeks
Visual Evoked Potentials (VEPs) EEG
Time frame: Baseline, 6 weeks and 24 weeks
Biological Motion EEG
Time frame: Baseline, 6 weeks and 24 weeks
Eye-tracking (ET) Biological Motion Task
Time frame: Baseline, 6 weeks and 24 weeks
Eye-tracking (ET) Activity Monitoring Task
Time frame: Baseline, 6 weeks and 24 weeks
Eye-tracking (ET) Interactive Social Task (IST)
Time frame: Baseline, 6 weeks and 24 weeks
Eye-tracking (ET) Pupillary Light Reflex Task
Time frame: Baseline, 6 weeks and 24 weeks
Eye-tracking (ET) Visual Search/Static Social Scenes Task
Time frame: Baseline, 6 weeks and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Derived from this study: PubMed 36929131Faja 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.
- Derived from this study: PubMed 35313957Shic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James McPartland, PhD principal investigator
Yale University Child Study Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NEPSY-II (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02996669, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.