Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 7:13 PM
Ignite Modification Date: 2025-12-24 @ 7:13 PM
NCT ID: NCT05186103
Brief Summary: This study aimed to investigate the performance of activities of daily living (ADL) among 53 children ages 6-10 years: 17 with high-severity ASD (HS-ASD), 16 with low-severity ASD (LS-ASD), and 20 controls with typical development. Methods: The assessment combined a parent-reported questionnaire (the Participation in Childhood Occupation; PICO) alongside the Pediatric Evaluation of Disability Inventory (PEDI self-care) and Performance-based task, the Washing Hands Structured Observation (WashHO).
Detailed Description: study objectives were to: (a) Examine participation characteristics in self-care and daily activities of school-age children with HS-ASD and LS-ASD compared to children with typical development, based on the parent-reported Participation in Childhood Occupation Questionnaire (PICO-Q) for ASD and PEDI (b) Establish the validity and reliability of the WashHO assessment. The research hypotheses were (A) Significant differences will be found among children with HS-ASD, children with LS-ASD, and children with typical development in results of the PICO-Q and the PEDI self-care subtest of independence. (B1) The internal consistency of the WashHO assessment will be at a Cronbach alpha level equal to or greater than 70. (B2) Significant differences will be found among children with HS-ASD, LS-ASD, and typical development in the WashHO assessment performance criteria, thus establishing the WashHO's discriminate validity. (B3) Significant correlations will be found among the four PICO-Q ADL items, which involve performing a sequence of actions (bathing, hygiene, clothing, and washing hands) and the WashHO assessment performance scores, establishing its convergent validity. (B4) Significant correlations will be found among the WashHO performance and degree of independence scores and the PEDI independence subtest in self-care, establishing the WashHO's concurrent validity.
Study: NCT05186103
Study Brief:
Protocol Section: NCT05186103