autism Autism Spectrum Disorder (ASD)
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: Having participated in LEAP-1 and/or LEAP-2; the criteria observed at wave-1 were: ASD group: 1. Male or female aged 6-30 years with an established clinician diagnosis of Autism Spectrum Disorder according to DSM-5 criteria; 2. Male or female with an IQ of 50 or above; 3. Able to participate and willing to give written informed consent; (a) Where participants are their own legal guardian (i.e. aged 18 years and older without intellectual disabilities and demonstrated capacity to consent), written informed 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; for adolescents and adults without capacity to consent: additional written assent from the volunteer (easy-read version); 4. Availability of a parent or legal guardian to provide information about the volunteer*s behaviour and symptoms by completing (on-line) questionnaires, during the institute visit, a separate home-visit or over the telephone, 5. Availability of a parent or carer to accompany the volunteer to all institute visits where participants are unable to travel on their own; 6. Participant on stable medication (min 8 weeks) at entrance point and over the course of study. Typically Developing (TD) control group: 1. Male or female aged 6-30 years; 2. Able to participate and willing to give written informed consent; For minors
Exclusion criteria
Exclusion criteria: All groups: 1. Presence of significant hearing or visual impairments not correctable by glasses or hearing aids; 2. A history of alcohol and / or substance abuse or dependence in the past year; 3. Presence of any MRI counter-indications (e.g., metal implants, braces, claustrophobia) or failure to give informed written consent to MRI scanning (or to provide GP details at centres where this is a pre-condition for scanning); 4. Presence or history of any Neurological Disorder/ significant trauma. ASD group: Presence of psychosis or bipolar disorder. TD group: Presence of any DSM-5 axis I and II psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trajectory of clinical symptomatology over time and in relation to underpinning cognitive and neurobiological abnormalities; identification of biomarkers that link to symptomatology and/ or that can be used to stratify ASD samples and/or to diagnose ASD, and/or serve as outcome markers. Primary parameters are: - Severity of ASD and comorbid symptoms (measured by questionnaires, psychiatric observation (ADOS) and psychiatric developmental interview (ADI-R) - Performance on neurocognitive tests - Brain structure and functioning, as measured by MRI and EEG/ERPs - Attention and social attention, as measured by eye-tracking technology | — |
Secondary
| Measure | Time frame |
|---|---|
| - Analyses of blood, urine, saliva, stool and hair samples | — |
Countries
Netherlands
Outcome results
None listed