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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

November 29, 2021

Last Update Submit

December 22, 2021

Conditions

Keywords

ASDself careADLdaily functionexecutive functions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (3)

HS-ASD

high-severity ASD

Other: observation

LS-ASD

low-severity ASD

Other: observation

control

typical development

Other: observation

Interventions

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).

HS-ASDLS-ASDcontrol

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Study participants with an ASD diagnosis were recruited from special education schools, special education classes located in regular schools, or mainstream schools through parent referral.no significant group differences were found for the participants' age, gender, socioeconomic status, or religion.

You may qualify if:

  • Hebrew speakers
  • study groups- ASD diagnosis provided by pediatricians or clinical psychologists according to DSM-5 criteria (APA, 2013).

You may not qualify if:

  • without ASD formal diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hana Levy-Dayan

Haifa, 3229232, Israel

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Observation

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Sara Rosenblum, Phd

    University of Haifa

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor in the Department of Occupational Therapy, Faculty of Social Welfare Affiliation: University of Haifa Collaborators:

Study Record Dates

First Submitted

November 29, 2021

First Posted

January 11, 2022

Study Start

January 1, 2018

Primary Completion

April 29, 2018

Study Completion

June 20, 2018

Last Updated

January 11, 2022

Record last verified: 2021-12

Locations