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:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT02751957
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of ASD based on DSM-5 criteria by a developmental pediatrician.
* a caretaker who speaks isiXhosa, Afrikaans or English
* lives within an area served by the Red Cross Neurodevelopmental clinic;
* willing to participate in the intervention and be randomized to the intervention or control group.
Exclusion Criteria:
* a neurodevelopmental disorder of known genetic etiology (eg. Downs syndrome)
* significant sensory or motor impairment (e.g. cerebral palsy)
* major physical problems
* uncontrolled seizures
* IQ below 35 as measured by mean age equivalence score on the Griffiths Scales of Mental Development
* unable to attend 3 assessments and 12, 1-hour, weekly consecutive intervention sessions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
72 Months
Study:
NCT02751957
Study Brief:
Protocol Section:
NCT02751957