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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT02721394
Eligibility Criteria:
Inclusion Criteria:
* Child aged under 9
* Child has identified intellectual disability or genetic syndrome associated with intellectual disability (e.g. Fragile X Syndrome)
* Child uses only phrase speech (i.e. 2-3 word utterances)
* Child displays self injury, aggression, property destruction at home
* Family carers aged over 18 with capacity to consent
* Family carer speaks English as first language (to ensure that the child understands English and will therefore understand researcher)
Exclusion Criteria:
* Child experiences health condition involving pain that is not well controlled by treatment
* Child is fully deaf / blind
* Child or family carer receiving active treatment in relation to child's behaviour (e.g. direct behavioural support, parenting programme etc.)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
9 Years
Study:
NCT02721394
Study Brief:
Protocol Section:
NCT02721394