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

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

      • Tel Aviv, Israel, 6291711
        • Clalit Health Services

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.
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)
up to 12 weeks
Child emotional aspects - Mastery motivation
Time Frame: up to 12 weeks
Dimension of Mastery Questionnaire (DMQ18)
up to 12 weeks
Child performance skills -Fine motor precision
Time Frame: up to 12 weeks
Bruininks-Oseretsky Test of Motor Proficiency (BOT2)
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
up to 12 weeks
Child performance skills - Sensory profile
Time Frame: up to 12 weeks
Short Sensory Profile (SSP2)
up to 12 weeks
Child performance skills -Core strength
Time Frame: up to 12 weeks
Prone Extension Posture
up to 12 weeks
Child performance skills - Visual motor integration
Time Frame: up to 12 weeks
Developmental Test of Visual-Motor Integration (VMI)
up to 12 weeks
Child performance skills - Draw a picture
Time Frame: up to 12 weeks
Goodenough-Harris Drawing Test (DAP)
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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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