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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07326267
Eligibility Criteria:
Inclusion Criteria:
* Regular school attendance (Anticipated ability to attend at least 70% of the planned intervention sessions during the study period);
* Written informed consent obtained from the family;
* Formal diagnosis of Autism Spectrum Disorder or Intellectual Disability, documented by an official disability report;
* Presence of observable difficulties in sensory processing and activities of daily living (ADL), verified through the student's Individualized Education Program (IEP) records;
* Ability to partially follow single-step basic instructions, as documented in the IEP records;
* Willingness of families and teachers to participate in follow-up assessments (T2 and beyond).
Exclusion Criteria:
* Uncontrolled epilepsy or other medical conditions that may interfere with participation or safety during sessions.
* Medical contraindications to modalities such as swinging or deep pressure or severe musculoskeletal limitations preventing participation in task-oriented ADL practice.
* Being in a period of severe acute behavioral crisis;
* Concurrent participation in occupational therapy or special education programs for ≥2 hours per week that would compromise data interpretation;
* Presence of severe visual or hearing impairments that would substantially limit the child's ability to perceive sensory stimuli, follow task instructions, or validly engage in assessment procedures;
* Inability to maintain family and/or teacher collaboration throughout the intervention period;
* Inconsistent school attendance during the intervention period (e.g., prolonged absenteeism);
* Insufficient language comprehension to engage with basic task instructions even with support.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
14 Years
Study:
NCT07326267
Study Brief:
Protocol Section:
NCT07326267