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Efficacy of the CO-OP Approach With Brazilian Children With Developmental Coordination Disorder

Primary Purpose

Developmental Coordination Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Orientation to Daily Occupational Performance
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Coordination Disorder focused on measuring child, goal, intervention, motor skills disorder, occupational therapy

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cognitive Orientation to daily Occupational Performance

    Arm Description

    One group was submitted to the CO-OP approach to learn cognitive strategies to perform the chosen tasks.

    Outcomes

    Primary Outcome Measures

    Canadian Occupational Performance Measure
    Change on performance and satisfaction on goals chosen by each child
    Performance Quality Rating Scale
    Change on occupational performance on goals chosen by each child as measured by external evaluators

    Secondary Outcome Measures

    Full Information

    First Posted
    April 2, 2017
    Last Updated
    April 12, 2017
    Sponsor
    Federal University of Minas Gerais
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03112746
    Brief Title
    Efficacy of the CO-OP Approach With Brazilian Children With Developmental Coordination Disorder
    Official Title
    Efficacy of the Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach With Brazilian Children With Developmental Coordination Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 26, 2009 (Actual)
    Primary Completion Date
    February 10, 2010 (Actual)
    Study Completion Date
    March 26, 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Minas Gerais

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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 parentsΒ΄ orientation. The Canadian Occupational Performance Measure and the Performance Quality Rating Scale were used as outcome measures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Developmental Coordination Disorder
    Keywords
    child, goal, intervention, motor skills disorder, occupational therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive Orientation to daily Occupational Performance
    Arm Type
    Experimental
    Arm Description
    One group was submitted to the CO-OP approach to learn cognitive strategies to perform the chosen tasks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Orientation to Daily Occupational Performance
    Other Intervention Name(s)
    CO-OP Approach
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Canadian Occupational Performance Measure
    Description
    Change on performance and satisfaction on goals chosen by each child
    Time Frame
    up to 12 weeks
    Title
    Performance Quality Rating Scale
    Description
    Change on occupational performance on goals chosen by each child as measured by external evaluators
    Time Frame
    up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    11471396
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11345512
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    14624835
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18400322
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15586853
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29260603
    Citation
    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.
    Results Reference
    derived

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    Efficacy of the CO-OP Approach With Brazilian Children With Developmental Coordination Disorder

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