EarliPoint Device for Autism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how effectively an eye-tracking device can identify autism or other developmental delays in infants. Researchers will observe how infants visually engage with their surroundings at 9 months and follow up at several intervals up to 24 months. The study targets generally healthy infants between 8-10 months old, without acute illnesses that could interfere with participation. Parents or caregivers must provide informed consent to participate.
As an unphased trial, this study offers parents a unique opportunity to contribute to groundbreaking research that could enhance early detection of developmental issues.
Do I need to stop my child's current medications for the trial?
The trial information does not specify whether you need to stop your child's current medications. It might be best to discuss this with the trial coordinators or your child's doctor.
What prior data suggests that the EarliPoint Investigational Device is safe for screening infants?
Research has shown that the EarliPoint Investigational Device has been used in past studies to measure how young children visually engage with social cues. In these studies, children tolerated the device well, experiencing no significant negative effects. This suggests the device is safe for use with infants.
The device tracks eye movement, a non-invasive process that neither enters the body nor causes discomfort. As it is not a medication or an invasive procedure, the risks are very low. Overall, previous research is reassuring and suggests the device is safe for screening purposes.
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a new approach to screening for autism in infants as young as 9 months old by measuring social visual engagement. Unlike traditional methods that often rely on behavioral checklists or assessments at older ages, this technique aims to identify signs much earlier. By tracking visual engagement over multiple time points, this method could offer a more dynamic and continuous insight into developmental patterns, potentially leading to earlier interventions and support for children with autism or developmental disabilities.
What evidence suggests that the EarliPoint Investigational Device is effective for screening autism?
Research shows that the EarliPoint Investigational Device, studied in this trial, could help screen young children for autism spectrum disorder (ASD). Early results suggest that this eye-tracking device accurately measures how children visually engage with others, often differing in children with autism. Studies indicate that identifying these differences early can lead to timely help, improving developmental outcomes. The device tracks how infants look at social cues, like faces, to identify potential delays. Although research with people continues, the focus on clear, objective measures instills confidence in its potential for early autism screening.
Who Is on the Research Team?
Warren R Jones, PhD
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Assessment
Eye-tracking session to measure social looking and completion of health and development questionnaires
Sequential Screening
Follow-up screenings at 12, 15, 18, 21, and 24 months using eye-tracking assays and questionnaires
Comprehensive Assessment
In-person developmental and diagnostic assessment for children showing signs of developmental delay or randomly selected children without signs
Follow-up
Participants are monitored for developmental outcomes and feedback is provided to parents/caregivers
What Are the Treatments Tested in This Trial?
Interventions
- EarliPoint Investigational Device
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
A general population cohort of 9-month-old infants presenting for well-child visits will be screened initially at 9 months of age, and then screened again sequentially at 12, 15, 18, 21, and 24 months, to test screening performance relative to outcome status with autism or developmental disabilities.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
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