Primary objective: To identify early cognitive, neural, behavioural and bio-markers which precede the onset of clinical symptoms of ASD, through obtaining measures of eye tracking, EEG/ERP, NIRS, cognitive performance and collecting DNA and…
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main dependent measure is the diagnosis of ASD and the severity of ASD
symptoms at age 36 months.
The main predictive measures for cognition, eye tracking and EEG/ERP are:
- Cognitive functioning (Mullen Scales of Early Learning)
- Time locked voltage changes (µV) at different electrode sites (EEG)
- Amplitude of event-related potentials wave to stimuli (ERPs)
- Evaluation of EEG power spectrum (frequency and time frequency analysis) (EEG)
- Power changes (µV2) at different electrode sites (EEG)
- Oxygenated and deoxygenated hemoglobin concentration changes (NIRS)
- Location of eye gaze and timing of eye movements (eye tracking)
- Anticipatory eye movements (eye tracking)
- Fixation duration (eye tracking)
Secondary outcome
Not applicable
Background summary
Young infants who have an older sibling with Autism Spectrum Disorder (ASD)
have a substantially increased risk for developing ASD themselves. The
cognitive, neural and behavioural mechanisms that underlie the development of
ASD are still unknown. This study is designed to examine the early cognitive,
neural, behavioural and bio-markers which precede the onset of clinical
symptoms of ASD in high-risk siblings and in healthy controls.
Study objective
Primary objective: To identify early cognitive, neural, behavioural and
bio-markers which precede the onset of clinical symptoms of ASD, through
obtaining measures of eye tracking, EEG/ERP, NIRS, cognitive performance and
collecting DNA and biochemical measures.
Secondary objective: To increase our understanding of early clinical symptoms
of ASD.
Study design
Prospective longitudinal observational study. Measures will be taken at age 5,
10, 14, 24, 36 months.
Study burden and risks
The study of the early markers that precede the clinical symptoms of ASD can
only be performed in very young children. All measures proposed have been used
earlier by the research team. There are no known risks associated with
participation in the proposed research. Blood for DNA and biochemistry will be
obtained at age 36 months through venipuncture by an experienced nurse.
Additionally, urine will be collected at this time point. The burden for both
participant and caregiver are kept as low as possible, see for a more elaborate
description the research protocol.
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
High-risk siblings:
- Age between 4 months and 6 months OR younger than 11 months
- Older full sibling with ASD (clinical diagnosis autism, PDD-NOS or Asperger syndrome)
- At least one parent speaks Dutch to child at home (does not need to be parent*s native language);Controls:
- Age between 4 months and 6 months OR younger than 11 months
- Older full sibling with typical development (by parent report)
- At least one parent speaks Dutch to child at home (does not need to be parent*s native language)
Exclusion criteria
High-risk siblings:
- Diagnosis of epilepsy or history of fits/convulsions
- Presence of genetic syndrome (in proband or infant) clearly related to ASD (e.g. Tuberous Sclerosis, Fragile-X)
- Presence of known significant uncorrected vision or hearing impairment in infant (reported to parent by a doctor or health professional)
- Infant was premature (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, foetal alcohol syndrome);Low-risk:
- Diagnosis of epilepsy or history of fits/convulsions
- Presence of known significant uncorrected vision or hearing impairment in infant (reported to parent by a doctor or health professional)
- Infant was premature (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)
- Interested in study because parents are concerned that their infant is developing ASD, despite negative family loadings
- Presence of ASD in 1st degree relatives
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42726.091.13 |