NCT02774135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2021

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

3.5 years

First QC Date

May 9, 2016

Last Update Submit

April 20, 2021

Conditions

Limited Participation in Daily Life Activities

Outcome Measures

Primary Outcomes (1)

  • Improvement of child participation

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

    up to 12 weeks

Secondary Outcomes (12)

  • Child performance skills

    up to 12 weeks

  • Child emotional aspects - Self efficacy

    up to 12 weeks

  • Parental aspects- Parental self efficacy

    up to 12 weeks

  • Child emotional aspects - Anxiety

    up to 12 weeks

  • Child emotional aspects - Mastery motivation

    up to 12 weeks

  • +7 more secondary outcomes

Study Arms (1)

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

direct occupational therapy interventionOTHER

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).

direct occupational therapy intervention

Eligibility Criteria

Age54 Months - 83 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Kindergarten's children referred to Occuptaion Therapy

You may qualify if:

  • kindergarten students of regular education
  • Hebrew speaking

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit Health Services

Tel Aviv, 6291711, Israel

Location

Study Officials

  • Leonard G Robinson, Md

    Clalit Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, MD, Pediatrics

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 17, 2016

Study Start

May 1, 2017

Primary Completion

October 31, 2020

Study Completion

April 19, 2021

Last Updated

April 21, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)