- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05186103
Activities of Daily Living Participation Characteristics Among School-Aged Children With Autism Spectrum Disorder
Participation of Children With Autism Using Parental Reporting Tools Combined With a Performance-based Tool, the Washing Hands Structured Observation (WashHO).
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Haifa, Israel, 3229232
- Hana Levy-Dayan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
HS-ASD
high-severity ASD
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The assessment combined a parent-reported questionnaire (the Participation in Childhood Occupation; PICO) alongside the Pediatric Evaluation of Disability Inventory (PEDI self-care) and a Performance-based task, the Washing Hands Structured Observation (WashHO).
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|
LS-ASD
low-severity ASD
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The assessment combined a parent-reported questionnaire (the Participation in Childhood Occupation; PICO) alongside the Pediatric Evaluation of Disability Inventory (PEDI self-care) and a Performance-based task, the Washing Hands Structured Observation (WashHO).
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control
typical development
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The assessment combined a parent-reported questionnaire (the Participation in Childhood Occupation; PICO) alongside the Pediatric Evaluation of Disability Inventory (PEDI self-care) and a Performance-based task, the Washing Hands Structured Observation (WashHO).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PICO-Q ASD
Time Frame: through study completion, an average of 3 Months
|
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).
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through study completion, an average of 3 Months
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PEDI Self-Care Subtest
Time Frame: through study completion, an average of 3 Months
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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.
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through study completion, an average of 3 Months
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the Washing Hands Structured Observation (WashHO)
Time Frame: through study completion, an average of 3 Months
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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.
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through study completion, an average of 3 Months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sara Rosenblum, Phd, University of Haifa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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