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Completed

NCT Number: NCT02774135

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.

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Key information

Age range

54 month–83 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Clalit Health Services

Tel Aviv, 6291711, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

direct occupational therapy intervention

Other

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).

Primary outcomes

  1. Improvement of child participation

    Time frame: up to 12 weeks

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

Secondary outcomes

  1. Child performance skills

    Time frame: up to 12 weeks

    Child Performance Skills Questionnaire (PSQ)

  2. Child emotional aspects - Self efficacy

    Time frame: up to 12 weeks

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

  3. Parental aspects- Parental self efficacy

    Time frame: up to 12 weeks

    Parental Efficacy Questionnaire

  4. Child emotional aspects - Anxiety

    Time frame: up to 12 weeks

    Preschool Anxiety Scale (PAS)

  5. Child emotional aspects - Mastery motivation

    Time frame: up to 12 weeks

    Dimension of Mastery Questionnaire (DMQ18)

  6. Child performance skills -Fine motor precision

    Time frame: up to 12 weeks

    Bruininks-Oseretsky Test of Motor Proficiency (BOT2)

  7. Child performance skills - Balance

    Time frame: up to 12 weeks

    Bruininks-Oseretsky Test of Motor Proficiency (BOT2)

  8. Child performance skills -Executive functions

    Time frame: up to 12 weeks

    Day - Night task

  9. Child performance skills - Sensory profile

    Time frame: up to 12 weeks

    Short Sensory Profile (SSP2)

  10. Child performance skills -Core strength

    Time frame: up to 12 weeks

    Prone Extension Posture

  11. Child performance skills - Visual motor integration

    Time frame: up to 12 weeks

    Developmental Test of Visual-Motor Integration (VMI)

  12. Child performance skills - Draw a picture

    Time frame: up to 12 weeks

    Goodenough-Harris Drawing Test (DAP)

Sponsors and collaborators

Lead sponsor

Clalit Health Services

Other

Collaborators

  • Tel Aviv University

Registry information

Official study title

A Prospective Cohort Study to Examine the Improvement in Preschoolers' Participation as a Result of Occupational Therapy Intervention

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
May 17, 2016
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.