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CompletedNCT02774135Updated Apr 21, 2021

Improvement in Preschoolers' Participation as a Result of Occupational Therapy Intervention

An observational study in Limited Participation in Daily Life Activities, sponsored by Clalit Health Services. Completed at 1 site in Israel. Open to participants aged 54 Months to 83 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-21.

Sponsored by Clalit Health Services · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
52
Ages
54 Months to 83 Months
Sex
All
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Study summary

This study evaluates the improvement of participation in everyday occupation among preschool children with mild developmental disabilities as a result of Occupational Therapy intervention.

Read the 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.

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Conditions studied

  • Limited Participation in Daily Life Activities
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In context

Lead sponsor

Clalit Health Services is the lead sponsor of 44 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
54 Months to 83 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Kindergarten's children referred to Occuptaion Therapy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • kindergarten students of regular education
  • Hebrew speaking

Exclusion criteria

Exclusion Criteria:

  • Students of special education
  • Attending physiotherapy or psychology treatments
  • Autistic Spectrum Disorder
  • Cerebral Palsy
  • Spina Bifida
  • Developmental Intellectual Disabilities
  • Blindness
  • Deafness
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
52 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Other: direct occupational therapy intervention

Interventions

  • Otherdirect occupational therapy intervention

    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).

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What researchers measure

Primary outcomes

  1. Improvement of child participation

    Improvement of Participation of daily occupation as measured with Child Participation Questionnaire (CPQ)

    Time frame: up to 12 weeks

Secondary outcomes

  1. Child performance skills

    Child Performance Skills Questionnaire (PSQ)

    Time frame: up to 12 weeks

  2. Child emotional aspects - Self efficacy

    Pictorial scale of Perceived Competence and Social Acceptances for Young Children (PSPCSA)

    Time frame: up to 12 weeks

  3. Parental aspects- Parental self efficacy

    Parental Efficacy Questionnaire

    Time frame: up to 12 weeks

  4. Child emotional aspects - Anxiety

    Preschool Anxiety Scale (PAS)

    Time frame: up to 12 weeks

  5. Child emotional aspects - Mastery motivation

    Dimension of Mastery Questionnaire (DMQ18)

    Time frame: up to 12 weeks

  6. Child performance skills -Fine motor precision

    Bruininks-Oseretsky Test of Motor Proficiency (BOT2)

    Time frame: up to 12 weeks

  7. Child performance skills - Balance

    Bruininks-Oseretsky Test of Motor Proficiency (BOT2)

    Time frame: up to 12 weeks

  8. Child performance skills -Executive functions

    Day - Night task

    Time frame: up to 12 weeks

  9. Child performance skills - Sensory profile

    Short Sensory Profile (SSP2)

    Time frame: up to 12 weeks

  10. Child performance skills -Core strength

    Prone Extension Posture

    Time frame: up to 12 weeks

  11. Child performance skills - Visual motor integration

    Developmental Test of Visual-Motor Integration (VMI)

    Time frame: up to 12 weeks

  12. Child performance skills - Draw a picture

    Goodenough-Harris Drawing Test (DAP)

    Time frame: up to 12 weeks

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Study locations

1 site
  • Clalit Health Services
    Tel Aviv, 6291711, Israel
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02774135
Lead sponsor
Clalit Health Services
Collaborators
Tel Aviv University
Responsible party
Dr. Gary Leonard Robinson (Dr, MD, Pediatrics, Clalit Health Services) — Principal investigator
First posted
May 17, 2016
Start date
May 1, 2017
Primary completion
Oct 31, 2020
Completion
Apr 19, 2021
Last update
Apr 21, 2021

Study contacts

Leonard G Robinson, Md
principal investigator · Clalit Health Services

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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