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Preschool Brain Imaging and Behaviour Project (PIP)

Preschool Brain Imaging and Behaviour Project (PIP) - PIP

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48368
Enrollment
92
Registered
2019-07-01
Start date
2020-07-30
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

autism autism spectrum disorder (ASD)

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: ASD group: - established or suspected clinical diagnosis of autism spectrum disorder according to the DSM-5 criteria - males or females, from age 3 year onward - non-verbal mental age >= 18 months (Mullen Scales) - all comorbidities allowed ADHD group: - established clinical diagnosis of ADHD according to the DSM-5 criteria - males or females, from age 4 year onward - non-verbal mental age >= 18 months (Mullen Scales) - all comorbidities allowed DD group: - clinical evaluation of developmental delay - males or females, from age 3 year onward - non-verbal mental age >= 18 months (Mullen Scales) - all comorbidities allowed Typically developing controls (TD): - males and females from the age of 30 months - no known developmental or medical condition affecting brain development and behaviour All groups: - Availability of a parent or caregiver who has sufficient command of language to a) provide written confirmed consent, and b) to provide information about the child*s behaviour, developmental history and symptoms.

Exclusion criteria

Exclusion criteria: All groups: - Significant hearing or visual impairments not corrected by glasses or hearing aids. - Presence of any MRI contraindications (e.g., metal implants, braces) , failure of a parent/ legal caregiver to give informed written consent to MRI scanning, or to provide contact details for a primary care physician at centres where this is a precondition for scanning; other reasons why a particular child may not tolerate the sleep scan (claustrophobia, sensitivity to noise, 'tummy sleeper') - MRI counterindications in the parent, or unavailability of any parent, legal guardian or otherwise familiar and trusted adult person to accompany the child to the MRI sleep scan. ASD and ADHD groups: - The presence of known genetic syndromes that have been associated with ASD, such as Tubereuze Sclerose, Fragiel X, Rett, Williams, etc.

Design outcomes

Primary

MeasureTime frame
Primary outcome measures: - severity of ASD symptoms, as measured by diagnostic interview (ADI-R) and observation schedules (ADOS) and by questionnaires completed by parents. The core measures are: Social Responsiveness Scale -Preschool (SRS-P), Childhood Routines Inventory-Revised (CRI-R), and Sensory Experience Questionnaire (SEQ) Primary predictors / potential biomarkers: 1) cognitive measures (from touch screen tests) that index various aspects of executive functioning and attention (sustained attention, inhibitory control, motion-coherence, reinforcement learning), social cognition (false Belief, emotion recognition, social reinforcement learning, gaze dot probe) and sensory processing (tactile sensory processing, auditory sensory processing) 2) eye-tracking measures of social motivation (gazing at dynamic and static natural social scenes with/without language), processing of predictability (predictability contingency), and sensory processing (pupillary light reflex, multisensory integration) 3) EEG/ERP measures of face processing (in particular the N170 latency), auditory processing (habituation or auditory gamma), functional brain connectivity (social/ non-social videos and resting state), sensory processing (tactile gating) 4) MRI measures of structural and functional brain connectivity (from structural MRI, DTI and resting-state scan, all during sleep) and MRS spectra of the thalamus (to measure GABA, glutamine and glutamate concentrations)

Secondary

MeasureTime frame
Secundary outcome measures are measures of comorbid disorders and temperament - Early/ Childhood Behaviour Questionnaire (CBQ) - Strength and Difficulties Questionnaire (SDQ) - Child Sleep Habits Questionnaire - Intolerance of uncertainty questionnaire - High Sensitivity Child Scale - Epilepsy questionnaire - Diet questionnaire

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026