- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02774135
Improvement in Preschoolers' Participation as a Result of Occupational Therapy Intervention
April 20, 2021 updated by: Dr. Gary Leonard Robinson, Clalit Health Services
A Prospective Cohort Study to Examine the Improvement in Preschoolers' Participation as a Result of Occupational Therapy Intervention
This study evaluates the improvement of participation in everyday occupation among preschool children with mild developmental disabilities as a result of Occupational Therapy intervention.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Preschoolers suffering from mild developmental disabilities are being referred to Occupational Therapy (OT) clinics according to limitation in participating of daily occupations.
As well these children often demonstrate behavior or emotional difficulties.
The primary treatment goal is promoting participation yet many times the treatment focuses on child's performance skills and not on occupation based activities.
Respectively its outcome measures are the child performance skills.
This study will document the therapeutic intervention, and evaluate its impact on child participation as well on his performance skills and emotional aspects.
Participants will be recruited from waiting list for Occupational Therapy at Clalit Health services, Child Development Institute, and will be evaluate four times.
First time on referral to waiting list ( At the present time due to long waiting list, children are waiting about three to four months before starting OT intervention), second time before treatment, third time after three of treatments and last follow-up after three months.
Study Type
Observational
Enrollment (Actual)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tel Aviv, Israel, 6291711
- Clalit Health Services
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 6 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Kindergarten's children referred to Occuptaion Therapy
Description
Inclusion Criteria:
- kindergarten students of regular education
- Hebrew speaking
Exclusion Criteria:
- Students of special education
- Attending physiotherapy or psychology treatments
- Autistic Spectrum Disorder
- Cerebral Palsy
- Spina Bifida
- Developmental Intellectual Disabilities
- Blindness
- Deafness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
direct occupational therapy intervention
group will be evaluated 4 times: on referral to waiting list for treatment, before and after 9-12 direct individual treatments of 45 minutes, and follow-up after 3 months.
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Short term direct individual occupational therapy (9-12 weeks).Participants will receive occupational therapy intervention according to health law.
The study will document the therapeutic intervention implemented in practice using the Documentation of Occupational Therapy Session during Intervention (DOTSI).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of child participation
Time Frame: up to 12 weeks
|
Improvement of Participation of daily occupation as measured with Child Participation Questionnaire (CPQ)
|
up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child performance skills
Time Frame: up to 12 weeks
|
Child Performance Skills Questionnaire (PSQ)
|
up to 12 weeks
|
Child emotional aspects - Self efficacy
Time Frame: up to 12 weeks
|
Pictorial scale of Perceived Competence and Social Acceptances for Young Children (PSPCSA)
|
up to 12 weeks
|
Parental aspects- Parental self efficacy
Time Frame: up to 12 weeks
|
Parental Efficacy Questionnaire
|
up to 12 weeks
|
Child emotional aspects - Anxiety
Time Frame: up to 12 weeks
|
Preschool Anxiety Scale (PAS)
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up to 12 weeks
|
Child emotional aspects - Mastery motivation
Time Frame: up to 12 weeks
|
Dimension of Mastery Questionnaire (DMQ18)
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up to 12 weeks
|
Child performance skills -Fine motor precision
Time Frame: up to 12 weeks
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Bruininks-Oseretsky Test of Motor Proficiency (BOT2)
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up to 12 weeks
|
Child performance skills - Balance
Time Frame: up to 12 weeks
|
Bruininks-Oseretsky Test of Motor Proficiency (BOT2)
|
up to 12 weeks
|
Child performance skills -Executive functions
Time Frame: up to 12 weeks
|
Day - Night task
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up to 12 weeks
|
Child performance skills - Sensory profile
Time Frame: up to 12 weeks
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Short Sensory Profile (SSP2)
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up to 12 weeks
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Child performance skills -Core strength
Time Frame: up to 12 weeks
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Prone Extension Posture
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up to 12 weeks
|
Child performance skills - Visual motor integration
Time Frame: up to 12 weeks
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Developmental Test of Visual-Motor Integration (VMI)
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up to 12 weeks
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Child performance skills - Draw a picture
Time Frame: up to 12 weeks
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Goodenough-Harris Drawing Test (DAP)
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up to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Leonard G Robinson, Md, Clalit Health Services
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Actual)
October 31, 2020
Study Completion (Actual)
April 19, 2021
Study Registration Dates
First Submitted
May 9, 2016
First Submitted That Met QC Criteria
May 12, 2016
First Posted (Estimate)
May 17, 2016
Study Record Updates
Last Update Posted (Actual)
April 21, 2021
Last Update Submitted That Met QC Criteria
April 20, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- COM150203CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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