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

Limited Participation in Daily Life Activities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774135
• Other study ID #: COM150203CTIL
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: April 19, 2021

Study information

• Verified date: April 2021
• Source: Clalit Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 19, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 54 Months to 83 Months

Eligibility

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

Related Conditions & MeSH terms

• Limited Participation in Daily Life Activities

Intervention

Other:
• direct 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).

Locations

Country	Name	City	State
Israel	Clalit Health Services	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Clalit Health Services	Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of child participation	Improvement of Participation of daily occupation as measured with Child Participation Questionnaire (CPQ)	up to 12 weeks
Secondary	Child performance skills	Child Performance Skills Questionnaire (PSQ)	up to 12 weeks
Secondary	Child emotional aspects - Self efficacy	Pictorial scale of Perceived Competence and Social Acceptances for Young Children (PSPCSA)	up to 12 weeks
Secondary	Parental aspects- Parental self efficacy	Parental Efficacy Questionnaire	up to 12 weeks
Secondary	Child emotional aspects - Anxiety	Preschool Anxiety Scale (PAS)	up to 12 weeks
Secondary	Child emotional aspects - Mastery motivation	Dimension of Mastery Questionnaire (DMQ18)	up to 12 weeks
Secondary	Child performance skills -Fine motor precision	Bruininks-Oseretsky Test of Motor Proficiency (BOT2)	up to 12 weeks
Secondary	Child performance skills - Balance	Bruininks-Oseretsky Test of Motor Proficiency (BOT2)	up to 12 weeks
Secondary	Child performance skills -Executive functions	Day - Night task	up to 12 weeks
Secondary	Child performance skills - Sensory profile	Short Sensory Profile (SSP2)	up to 12 weeks
Secondary	Child performance skills -Core strength	Prone Extension Posture	up to 12 weeks
Secondary	Child performance skills - Visual motor integration	Developmental Test of Visual-Motor Integration (VMI)	up to 12 weeks
Secondary	Child performance skills - Draw a picture	Goodenough-Harris Drawing Test (DAP)	up to 12 weeks