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Early cognitive, social and neural mechanisms that precede clinical onset of ASD in a community sample

Recruiting
Conditions
Autism Spectrum Disorder
10057167
10010118
Registration Number
NL-OMON49325
Lead Sponsor
Radboud Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

High-risk infants
Age between 18 months and 24 months old
At least one of the parents understands and speaks Dutch
Positive screen on the Communication and Social development Signals (CoSoS)
(with a score >=3)
Caregiver and/or well-baby office professional (doctor, nurse) has ASD-specific
concerns about their child

Low-risk infants
Age between 18 months and 24 months old
At least one of the parents understands and speaks Dutch
Negativescreen on the Communication and Social development Signals (CoSoS)
(with a score <3)
Caregiver and/or professional does not have any ASD-specific concerns about the
child

Exclusion Criteria

High-risk infants
Diagnosis of epilepsy or history of fits/convulsions in infant (not including
febrile convulsions);
Known presence of genetic syndrome (in proband or infant) clearly related to
ASD (e.g. TSC, FXS, 22q11, 16p11.2, Rett*s)
Presence of known significant uncorrected vision or hearing impairment in
infant (reported to parent by a doctor or health care professional)
Infant was born prematurely (pre 36 weeks)
Infant is looked after by the state (e.g. foster care), or other situation in
which neither birth parent is involved in the infant*s care.

Low-risk infants
Diagnosis of epilepsy or history of fits/convulsions in infant;
Known presence of genetic syndrome (in proband or infant) clearly related to
ASD (e.g. TSC, FXS, 22q11, 16p11.2, Rett*s)
Presence of known significant uncorrected vision or hearing impairment in
infant (reported to parent by a doctor or health care professional)
Infant was born prematurely (pre 36 weeks)
Infant is looked after by the state (e.g. foster care), or other situation in
which neither birth parent is involved in the infant*s care.
Presence of known significant developmental or medical condition in infant
likely to affect brain development or infant*s ability to participate in the
study (e.g. Cerebral Palsy, Down*s syndrome, cystic fibrosis)
Presence of ASD in 1st degree relatives

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p><br /><br>Behavioural<br /><br>Communication and Social development Signals (CoSoS)<br /><br>Social Responsiveness Scale (SRS)<br /><br>Autism Diagnostic Observation Schedule (ADOS-2)<br /><br><br /><br>EEG/Eye-Tracking<br /><br>Amplitude/latency of event-related potentials (ERPs) to visual and auditory<br /><br>stimuli<br /><br>Evaluation of EEG power (time frequency analysis)<br /><br>Location of eye gaze and fixation duration (eye-tracking)</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>n.a.</p><br>
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