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Mechanisms underlying the development of autism: a multi-site prospective study in very young high-risk siblings and controls

Mechanisms underlying the development of autism: a multi-site prospective study in very young high-risk siblings and controls - Development of autism

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41412
Enrollment
105
Registered
2013-09-03
Start date
2014-05-19
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Interventions

None listed

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)