Autism Spectrum DisorderNCT05186103
Activities of Daily Living Participation Characteristics Among School-Aged Children With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by Sara Rosenblum at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- observation
- How many people
- 53 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2018to 20 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Hebrew speakers
- study groups- ASD diagnosis provided by pediatricians or clinical psychologists according to DSM-5 criteria (APA, 2013).
Who cannot join
- without ASD formal diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Participation of Children With Autism Using Parental Reporting Tools Combined With a Performance-based Tool, the Washing Hands Structured Observation (WashHO).
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).
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- observation
- Keywords
- ASD, self care, ADL, daily function, executive functions
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| HS-ASD | high-severity ASD Receives: Other: observation | |
| LS-ASD | low-severity ASD Receives: Other: observation | |
| control | typical development Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jan 2018
- Primary completion29 Apr 2018
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Rosenblum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Rosenblum, University of Haifa
- Investigators
- Sara Rosenblum, Phd, Study director, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186103
- Sponsor's protocol ID
- ADL
- Status last verified
- Dec 2021
- First submitted
- 29 Nov 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participation of Children With Autism Using Parental Reporting Tools Combined With a Performance-based Tool, the Washing Hands Structured Observation (WashHO).
- ClinicalTrials.gov ID
- NCT05186103
- Acronym / sponsor ID
- ADL
- Conditions
- Autism Spectrum Disorder
- Keywords
- ASD, self care, ADL, daily function, executive functions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Sara RosenblumUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 29 Apr 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HS-ASD | – | Other: observationhigh-severity ASD |
| LS-ASD | – | Other: observationlow-severity ASD |
| control | – | Other: observationtypical development |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Hebrew speakers
- study groups- ASD diagnosis provided by pediatricians or clinical psychologists according to DSM-5 criteria (APA, 2013).
Key exclusion criteria (1 listed)
- without ASD formal diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationThe 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). | Other | HS-ASD, LS-ASD, control |
Primary outcome
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).
PEDI Self-Care Subtest
Time frame: through study completion, an average of 3 Months
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.
the Washing Hands Structured Observation (WashHO)
Time frame: through study completion, an average of 3 Months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Rosenblum, Phd study director
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Sara Rosenblum at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PICO-Q ASD (time frame: through study completion, an average of 3 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.