Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT03438994
Eligibility Criteria:
1. Inclusion Criteria:
1. All participants:
* Aged 30 months - 5 years inclusive
2. ASD Participants:
* Diagnosis of autism spectrum disorder on the basis of DSM-V criteria or equivalent ICD-10 framework (F84): childhood autism (F84.0), atypical autism (F84.1), and Asperger's syndrome (F84.5)
3. OND participants:
* Other childhood developmental disorders including, but not limited to,
* Attention Deficit Hyperactivity Disorder,
* Developmental Coordination Disorder,
* Intellectual disability,
* Non- verbal disability and
* Communication Disability.
* Sensory and motor impairments will be included
2. Exclusion Criteria:
1. Typically developing participants:
* Diagnosis or suspicion of
* Neuropathology
* Psychopathology
* Sensory or motor disorder including mild tremors
2. ASD participants:
* Uncorrected sensory (visual, hearing) impairments
* Presence of any motor impairments or behavioural impairment that may obstruct testing
3. OND participants:
* Sub-clinical or secondary expressions of ASD
* Uncorrected hearing or vision impairments
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Months
Maximum Age:
5 Years
Study:
NCT03438994
Study Brief:
Protocol Section:
NCT03438994