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EU-AIMS Longitudinal European Autism Project (EU-AIMS LEAP): an exploratory study

EU-AIMS Longitudinal European Autism Project (EU-AIMS LEAP): an exploratory study - Leap

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON40536
Enrollment
300
Registered
2013-11-15
Start date
2014-01-01
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Autism

Interventions

None listed

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: ASD group: (1) Males and females aged 6-30 years with an established diagnosis of Autism Spectrum Disorder according to DSM-IV; idiopathic and syndromic forms of ASD (e.g., Fragile X, Rett Syndrome) are allowed (2) Males and females with IQ 50+ (3) All comorbidities (e.g., ADHD, anxiety) allowed except for psychosis and bipolar disorder (4) Informed written consent; (a) Where participants are their own legal guardian (i.e. aged 18 years and older without learning difficulties and demonstrated capacity to consent), written consent from the volunteer; (b) Where participants are minors and/ or do not have capacity to consent, written informed consent from the parent or legal guardian; verbal assent from the volunteer prior to each assessment (5) Availability of parent or caregiver who accompanies the volunteer to all institute visits and provides information about the volunteer*s behavior and symptoms. For adults with ASD who are their own legal guardian, availability of a parent who provides information about behavior/ symptoms during the institute visit, a separate home-visit or over the telephone. (6) Participant on stable medication (min 8 weeks) at entrance point and over the course of study allowed Typically Developing (TD) control group: Males and females aged 6-30 years Learning Difficulties (LD) control group: Males and females aged 13-30 years Syndromic forms of LD (Down*s Syndrome) and unspecified general learning disabilities allowed

Exclusion criteria

Exclusion criteria: (1) Significant hearing or visual impairments not correctable by glasses or hearing aids (2) Alcohol and / or substance abuse or dependence in the past year (3) Any MRI counter-indications (e.g., metal implants, braces) ASD and LD group: presence of psychosis or bipolar disorder TD group: presence of any DSM-V axis I and II psychiatric disorders

Design outcomes

Primary

MeasureTime frame
Phenotyping of ASD will involve questionnaires and semi-structured interviews probing the presence and severity of ASD. The MRI session includes structural MRI, resting state, DTI and fMRI. Outside the scanner several computer based tasks will be conducted to assess cognitive abilities. Eye-tracking and EEG tasks will also be performed outside the scanner.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)