Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413316
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-08
Brief Title:
ABC-CT Pre-School Feasibility Study
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Autism Biomarkers Consortium for Clinical Trials ABC-CT Pre-School Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The ABC-CT Pre-School Feasibility Study will collect data in a cohort of participants to determine feasibility of the measures used in the ABC-CT Phase 1 study and ABC-CT Confirmation study in 3-5 year old participants We will be able to examine distributional and psychometric properties of the measures in this group and obtain preliminary estimates of group differences and associations with clinical measures In addition we aim to determine the viability of EEG and ET measures as potential biomarkers in 3-5-year-old children with ASD Viability will be evaluated in terms of a valid data acquisition including adequate levels of participant compliance b reliability of data collection across sites c construct validity in relation to social function and d distributionalpsychometric properties
Primary Objectives
1 To evaluate the feasibility of collecting EEG and ET assessments used in the Phase 1 and Confirmation studies in 3-5 year old
2 To determine the viability of adapted EEG and ET measures as potential biomarkers in 3-5-year-old children with ASD and TD To further evaluate the psychometric properties of the ET and EEG biomarkers in the 3-5 year old population
Secondary Objectives
To collect blood samples from all ASD subjects and their biological parents for future genomic analyses and to share raw processed and analyzed data via the National Database for Autism Research NDAR and National Institute of Health National Institute of Mental Health NIHNIMH Data Repositories to create a community resource accessible for use by all qualified investigators
To compare estimates of key distributional parameters across the original confirmation and feasibility samples to determine whether the markers profiles are sufficiently compatible to use in studies combining pre-school and school-aged children
The Preschool Feasibility sample will be evenly divided 25 ASD 25 TD aged 3-5 with IQ ranging from 60-150 recruited from 5 clinical implementation sites in the US
Endpoints
To collect and analyze a new cohort of participants to evaluate the feasibility of ET and EEG acquisition in 3-5 year olds We will also evaluate ET and EEG measures for potential utility as biomarkers in clinical trials Primary endpoints include evaluation of 1 Acquisition 2 Construct Validity 3 Discriminant Validity
Primary Biomarker Outcome Variables
1 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 3 to 5 years of age
2 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
Primary Objectives
1 To evaluate the feasibility of collecting EEG and ET assessments used in the Phase 1 and Confirmation studies in 3-5 year old
2 To determine the viability of adapted EEG and ET measures as potential biomarkers in 3-5-year-old children with ASD and TD To further evaluate the psychometric properties of the ET and EEG biomarkers in the 3-5 year old population
Secondary Objectives
To collect blood samples from all ASD subjects and their biological parents for future genomic analyses and to share raw processed and analyzed data via the National Database for Autism Research NDAR and National Institute of Health National Institute of Mental Health NIHNIMH Data Repositories to create a community resource accessible for use by all qualified investigators
To compare estimates of key distributional parameters across the original confirmation and feasibility samples to determine whether the markers profiles are sufficiently compatible to use in studies combining pre-school and school-aged children
The Preschool Feasibility sample will be evenly divided 25 ASD 25 TD aged 3-5 with IQ ranging from 60-150 recruited from 5 clinical implementation sites in the US
Endpoints
To collect and analyze a new cohort of participants to evaluate the feasibility of ET and EEG acquisition in 3-5 year olds We will also evaluate ET and EEG measures for potential utility as biomarkers in clinical trials Primary endpoints include evaluation of 1 Acquisition 2 Construct Validity 3 Discriminant Validity
Primary Biomarker Outcome Variables
1 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 3 to 5 years of age
2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None