Autism Spectrum Disorder Clinical Trial
Official title:
Participation of Children With Autism Using Parental Reporting Tools Combined With a Performance-based Tool, the Washing Hands Structured Observation (WashHO).
NCT number | NCT05186103 |
Other study ID # | ADL |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | June 20, 2018 |
Verified date | December 2021 |
Source | University of Haifa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 53 |
Est. completion date | June 20, 2018 |
Est. primary completion date | April 29, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 10 Years |
Eligibility | Inclusion Criteria: Hebrew speakers - study groups- ASD diagnosis provided by pediatricians or clinical psychologists according to DSM-5 criteria (APA, 2013). Exclusion Criteria: - without ASD formal diagnosis |
Country | Name | City | State |
---|---|---|---|
Israel | Hana Levy-Dayan | Haifa |
Lead Sponsor | Collaborator |
---|---|
Sara Rosenblum |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PICO-Q ASD | The 34-item PICO-Q for ASD measures the level, enjoyment, and frequency of performance for children's participation in daily occupations in five domains: ADL (16 items), academic activity (seven items), play and leisure (four items), social functioning (four items), and routines and habits (two items; Bar-Shalita et al., 2009; Heller., 2013). In this study, each child could choose two addition items in which they were participating, and a handwashing item was added. Each item has four scores: difficulty in performance, frequency, involvement, and level of enjoyment, and scores range from 1 (low) to 5 (high). | through study completion, an average of 3 Months | |
Primary | PEDI Self-Care Subtest | Pediatric Evaluation of Disability Inventory- parent report about children's ADL performance abilities (Haley et al., 1992). The test includes eight items measuring the typical amount of assistance the caregiver provides during the child's completion of tasks such as eating, grooming, and handwashing. Each item is scored from 5 (independence, no physical assistance or supervision) to 0 (total assistance, the caregiver does the entire task) and includes scoring of frequency-type adjustments. The total scale score ranges between 0 and 100, with lower scores indicating higher severity levels. | through study completion, an average of 3 Months | |
Primary | the Washing Hands Structured Observation (WashHO) | was developed based on the Do-Eat Performance-Based Assessment for Children (Do-Eat; Josman et al., 2010). examines BADL performance, sensorimotor skills, and executive functions abilities across the child's natural environments. includes four domains (a) performance analysis (10 items), (b) sensorimotor skills (SM; six items), (c) executive functions (EF; nine items), and (d) 10 unique performance characteristics. | through study completion, an average of 3 Months |
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