Clinical trial NCT02774135: Improvement in Preschoolers' Participation as a Result of Occupational Therapy Intervention
Official title: A Prospective Cohort Study to Examine the Improvement in Preschoolers' Participation as a Result of Occupational Therapy Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Limited Participation in Daily Life Activities
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2016-05-17
Enrollment: 52
Sex: ALL
Minimum age (years): 54
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kindergarten's children referred to Occuptaion Therapy

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement of child participation
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Child performance skills
timeFrame: up to 12 weeks
measure: Child emotional aspects - Self efficacy
timeFrame: up to 12 weeks
measure: Parental aspects- Parental self efficacy
timeFrame: up to 12 weeks
measure: Child emotional aspects - Anxiety
timeFrame: up to 12 weeks
measure: Child emotional aspects - Mastery motivation
timeFrame: up to 12 weeks
measure: Child performance skills -Fine motor precision
timeFrame: up to 12 weeks
measure: Child performance skills - Balance
timeFrame: up to 12 weeks
measure: Child performance skills -Executive functions
timeFrame: up to 12 weeks
measure: Child performance skills - Sensory profile
timeFrame: up to 12 weeks
measure: Child performance skills -Core strength
timeFrame: up to 12 weeks
measure: Child performance skills - Visual motor integration
timeFrame: up to 12 weeks
measure: Child performance skills - Draw a picture
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Clalit Health Services
Study officials:
affiliation: Clalit Health Services
name: Leonard G Robinson, Md
role: PRINCIPAL_INVESTIGATOR
References: