Autism Spectrum DisorderABC-CTNCT04841525
Autism Biomarker Consortium for Clinical Trials (ABC-CT): Follow-up Study
An observational study of Autism Spectrum Disorder, run by Yale University at 1 site in United States.
Trial summary
This is a multicenter longitudinal follow-up study to the main study of an a registered already (NCT# ). The Follow-up Study (T4) will assess the Main Study cohort for an additional longitudinal time point approximately 2-5 years after the initial study. 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
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 11 Aug 2022
- 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)).
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- 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, 06512
About this study
This is a multicenter longitudinal follow-up study to the main study of an a registered already (NCT# ). The Follow-up Study (T4) will assess the Main Study cohort for an additional longitudinal time point approximately 2-5 years after the initial study. Children participating in the Follow-up Study will be approximately 8-16 years old.
The aims of the main study is 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 the detailed description
All participants who were initially eligible for the main study will be eligible and invited to return regardless of their participation at T2/T3 or current medication/psychiatric status using an intent-to-treat model. The follow-up study will conduct one additional timepoint with participants who enrolled in the main study.
In the Follow-up Study of the Main Study ABC-CT cohort, the investigators will re-administer the biomarker and clinical batteries 2-5 years after original study enrollment. This will allow the investigators to:
- Assess long-term stability of the markers, extending the analyses of reliability and consistency from the first phase of the consortium.
- Perform a more robust assessment of sensitivity to change, taking advantage of a longer developmental window in which participants are expected to exhibit greater clinical progression.
- Evaluate the longitudinal predictive value of the biomarkers by examining the association of their baseline values with later measures of social function.
- 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.
N170 Latency to Upright Human Faces
The N170 Latency to Upright Human Faces (N170 latency) is a scalp recorded EEG event-related potential (ERP) component elicited by perception of the upright human face. Recorded over the posterior-temporal right hemisphere, the latency (or speed) of the peak of the N170 ERP component occurs at approximately 200 msec in children aged 6 to 11 years of age.
Measured: 5 years
Oculomotor Index of Gaze to Human Faces (OMI)
Onscreen gaze position data, reflected in percentage of foveation (angling of the eyes to focus on a particular object) to human faces (Face%) relative to total valid foveation time across three assays.
Measured: 5 years
VABS: Vineland Adaptive Behavior Scales- III Socialization
Administered in person visit during T4D1 or parent phone interview. The Socialization score is based on 3 subdomains of Interpersonal Relationships, Play \& Leisure, Coping Scales. The V-Scaled scores, which are specifically designed to measure change over time, are only available for the subdomains. The primary norm-referenced scores for the subdomains are v-scale scores, which have a mean of 15 and standard deviation (SD) of 3. The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start9 Apr 2021
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 265 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
- NCT04841525
- Sponsor's protocol ID
- 1509016477_b
- Other IDs
- U01FD006888, U19MH108206
- Acronym
- ABC-CT
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2021
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Biomarker Consortium for Clinical Trials (ABC-CT): Follow-up Study
- ClinicalTrials.gov ID
- NCT04841525
- Acronym / sponsor ID
- ABC-CT / 1509016477_b
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 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
- 9 Apr 2021 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 12 Apr 2021 (actual)
- 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 follow-up study to the main study of an a registered already (NCT# ). The Follow-up Study (T4) will assess the Main Study cohort for an additional longitudinal time point approximately 2-5 years after the initial study. Children participating in the Follow-up Study will be approximately 8-16 years old.
The aims of the main study is 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.
Detailed description
All participants who were initially eligible for the main study will be eligible and invited to return regardless of their participation at T2/T3 or current medication/psychiatric status using an intent-to-treat model. The follow-up study will conduct one additional timepoint with participants who enrolled in the main study.
In the Follow-up Study of the Main Study ABC-CT cohort, the investigators will re-administer the biomarker and clinical batteries 2-5 years after original study enrollment. This will allow the investigators to:
- Assess long-term stability of the markers, extending the analyses of reliability and consistency from the first phase of the consortium.
- Perform a more robust assessment of sensitivity to change, taking advantage of a longer developmental window in which participants are expected to exhibit greater clinical progression.
- Evaluate the longitudinal predictive value of the biomarkers by examining the association of their baseline values with later measures of social function.
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
N170 Latency to Upright Human Faces
Time frame: 5 years
The N170 Latency to Upright Human Faces (N170 latency) is a scalp recorded EEG event-related potential (ERP) component elicited by perception of the upright human face. Recorded over the posterior-temporal right hemisphere, the latency (or speed) of the peak of the N170 ERP component occurs at approximately 200 msec in children aged 6 to 11 years of age.
Oculomotor Index of Gaze to Human Faces (OMI)
Time frame: 5 years
Onscreen gaze position data, reflected in percentage of foveation (angling of the eyes to focus on a particular object) to human faces (Face%) relative to total valid foveation time across three assays.
VABS: Vineland Adaptive Behavior Scales- III Socialization
Time frame: 5 years
Administered in person visit during T4D1 or parent phone interview. The Socialization score is based on 3 subdomains of Interpersonal Relationships, Play \& Leisure, Coping Scales. The V-Scaled scores, which are specifically designed to measure change over time, are only available for the subdomains. The primary norm-referenced scores for the subdomains are v-scale scores, which have a mean of 15 and standard deviation (SD) of 3. The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives.
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 Apr 2023.
- Individual participant dataSharing planned: Yes
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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 Apr 2023. 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?
N170 Latency to Upright Human Faces (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2023.