- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03112746
Efficacy of the CO-OP Approach With Brazilian Children With Developmental Coordination Disorder
April 12, 2017 updated by: Clarice Ribeiro Soares Araujo, Federal University of Minas Gerais
Efficacy of the Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach With Brazilian Children With Developmental Coordination Disorder
Children with Developmental Coordination Disorder (DCD) have difficulties performing daily activities which reflects negatively on participation, impacting their lives.
To date, there are a number of interventions to improve performance of these children on activities they want or need to.
In Brazil, there is little research on the efficacy of such approaches.
Our main objective was to start a set of studies to examine the effects of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP Approach) protocol on occupational performance and satisfaction of Brazilian children who have DCD; to examine whether children were able to transfer strategies and skills learned during CO-OP to untrained goals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Background.
Children with Developmental Coordination Disorder (DCD) have difficulties performing daily activities which reflects negatively on participation, impacting their lives.
Objectives.
To examine the effects of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP Approach) protocol on occupational performance and satisfaction of Brazilian children who have DCD; to examine whether children were able to transfer strategies and skills learned during CO-OP to untrained goals.
Methods.
A pre-post group comparison design with eight boys aged 6-10 years old.
Children participated in 12 CO-OP sessions with their parents twice a week, with an extra session added to the protocol for parents´ orientation.
The Canadian Occupational Performance Measure and the Performance Quality Rating Scale were used as outcome measures.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- poor motor performance measured by a motor performance test (cut off score below the 15th percentile).
- poor performance on academic and daily living activities measured by the Developmental Coordination Disorder Questionnaire answered by the parents.
- attending regular education with no evidence of marked school delay (over a year).
- cognitive development within the expected age range according to the Wechsler Intelligence Scale for Children-Third Edition (WISC-III).
Exclusion Criteria:
- signs of neurological or neuromuscular disorder.
- presence of intellectual disability.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Orientation to daily Occupational Performance
One group was submitted to the CO-OP approach to learn cognitive strategies to perform the chosen tasks.
|
In CO-OP Approach, therapists use mediational techniques to teach cognitive strategies - GOAL, PLAN, DO, CHECK - to improve occupational performance in goals chosen by the children in collaboration with them and their parents.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Canadian Occupational Performance Measure
Time Frame: up to 12 weeks
|
Change on performance and satisfaction on goals chosen by each child
|
up to 12 weeks
|
Performance Quality Rating Scale
Time Frame: up to 12 weeks
|
Change on occupational performance on goals chosen by each child as measured by external evaluators
|
up to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Miller LT, Polatajko HJ, Missiuna C, Mandich AD, Macnab JJ. A pilot trial of a cognitive treatment for children with developmental coordination disorder. Hum Mov Sci. 2001 Mar;20(1-2):183-210. doi: 10.1016/s0167-9457(01)00034-3.
- Mandich AD, Polatajko HJ, Rodger S. Rites of passage: understanding participation of children with developmental coordination disorder. Hum Mov Sci. 2003 Nov;22(4-5):583-95. doi: 10.1016/j.humov.2003.09.011.
- Mandich AD, Polatajko HJ, Macnab JJ, Miller LT. Treatment of children with Developmental Coordination Disorder: what is the evidence? Phys Occup Ther Pediatr. 2001;20(2-3):51-68.
- Green D, Chambers ME, Sugden DA. Does subtype of developmental coordination disorder count: is there a differential effect on outcome following intervention? Hum Mov Sci. 2008 Apr;27(2):363-82. doi: 10.1016/j.humov.2008.02.009. Epub 2008 Apr 8.
- Carswell A, McColl MA, Baptiste S, Law M, Polatajko H, Pollock N. The Canadian Occupational Performance Measure: a research and clinical literature review. Can J Occup Ther. 2004 Oct;71(4):210-22. doi: 10.1177/000841740407100406.
- Araujo CRS, Cardoso AA, Magalhaes LC. Efficacy of the cognitive orientation to daily occupational performance with Brazilian children with developmental coordination disorder. Scand J Occup Ther. 2019 Jan;26(1):46-54. doi: 10.1080/11038128.2017.1417476. Epub 2017 Dec 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 26, 2009
Primary Completion (Actual)
February 10, 2010
Study Completion (Actual)
March 26, 2010
Study Registration Dates
First Submitted
April 2, 2017
First Submitted That Met QC Criteria
April 12, 2017
First Posted (Actual)
April 13, 2017
Study Record Updates
Last Update Posted (Actual)
April 13, 2017
Last Update Submitted That Met QC Criteria
April 12, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COEP/UFMG ETIC Nº 103/2009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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