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

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 300

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

(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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures