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

niversitair Medisch Centrum Sint Radboud0 sites300 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Observational invasive

Sponsor

niversitair Medisch Centrum Sint Radboud

•(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

•(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