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Effects of CO-OP Approach on Activity and Participation of Brazilian Children With Developmental Coordination Disorder

Primary Purpose

Motor Skills Disorders, Attention Deficit and Disruptive Behavior Disorders

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
standard CO-OP Approach
standard CO-OP Approach plus coaching parents
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motor Skills Disorders

Eligibility Criteria

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

Inclusion Criteria:

  • score on MABC-2 below the 15th percentile;
  • score on DCDQ-Brazil below age expectation, indicating problems on everyday living and/or academic skills;
  • cognitive development within the expected age range according to the Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV);
  • no diagnosis or signs of neurological or neuromuscular diseases.

Exclusion Criteria:

  • no reading ability;
  • child refuses to participate on assessment sessions.

Sites / Locations

  • Federal University of Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard CO-OP Approach

standard CO-OP Approach plus coaching parents

Arm Description

Task oriented and client-centred intervention with 12 sessions (10 interventional and 2 assessment sessions) with children and parents.

Task oriented and client-centred intervention with 12 sessions (10 interventional and 2 assessment sessions) with children and parents with a "boost" of 4 group sessions of coaching for parents in groups.

Outcomes

Primary Outcome Measures

Changes on the Canadian Occupational Performance Measure (COPM)
Changes on frequency on the Participation and Environment Measure -Child and Youth (PEM-CY)
Changes on involvement on the Participation and Environment Measure -Child and Youth (PEM-CY)
Changes on the Performance Quality Rating Scale (PQRS)

Secondary Outcome Measures

Changes on Motor Assessment Battery for Children Second Edition (MABC2)
Changes on Five Digits Test (FDT)
Changes on the Self-Perception Profile for children
Changes on Tower of London Test (TOL)

Full Information

First Posted
August 31, 2016
Last Updated
February 12, 2019
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT02893852
Brief Title
Effects of CO-OP Approach on Activity and Participation of Brazilian Children With Developmental Coordination Disorder
Official Title
Effects of the Cognitive Orientation to Daily Occupational Performance Approach on Activity and Participation of Brazilian Children With Developmental Coordination Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 12, 2016 (undefined)
Primary Completion Date
December 18, 2017 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to investigate the effects of the Cognitive Orientation to daily daily Occupational Performance Approach (CO-OP Approach) on activity and participation in school-aged children with developmental coordination disorder (DCD).
Detailed Description
Children with difficulty performing activities that reflect negatively on participation can meet the criteria for Developmental Coordination Disorder (DCD), which might impact their lives, leading to social isolation, depression and anxiety. Several studies have examined the effectiveness of different intervention approaches, including process-oriented approaches that focus on enhancing body functions and structures to improve performance on functional tasks. Although pediatric occupational therapists have traditionally used such approaches, evidence strongly suggests effectiveness for task-oriented interventions that focus on the performance of tasks that the child finds difficult to do. Among these, CO-OP Approach showed strong treatment effects. In CO-OP Approach, therapists use mediational techniques to teach cognitive strategies to improve occupational performance in goals chosen by the children. There is a need to examine systematic intervention alternatives for Brazilian children with DCD, and only one study examined occupational therapy intervention strategies for children with DCD. The main purpose of the study is to examine the effects of two intervention models based on CO-OP Approach. The investigators will examine if a boosting on parent's engagement in CO-OP can improve skill acquisition, generalization and transfer in children with DCD. A pre-post design will be used and two groups will be included in this study (1) one receiving standard CO-OP Approach, (2) one receiving standard CO-OP Approach and an addition of coaching sessions in groups for parents. Follow-up data will be collected 3 months later.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motor Skills Disorders, Attention Deficit and Disruptive Behavior Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard CO-OP Approach
Arm Type
Active Comparator
Arm Description
Task oriented and client-centred intervention with 12 sessions (10 interventional and 2 assessment sessions) with children and parents.
Arm Title
standard CO-OP Approach plus coaching parents
Arm Type
Experimental
Arm Description
Task oriented and client-centred intervention with 12 sessions (10 interventional and 2 assessment sessions) with children and parents with a "boost" of 4 group sessions of coaching for parents in groups.
Intervention Type
Behavioral
Intervention Name(s)
standard CO-OP Approach
Other Intervention Name(s)
CO-OP Approach
Intervention Description
The CO-OP protocol originally developed by Mandich and Polatajko (2004) comprises 12 sessions. The therapist teaches the participants a global cognitive strategy: GOAL - PLAN - DO - CHECK. The participants use the global strategy and cooperate to learn specific strategies to solve each task performance breakdown identified through Dynamic Performance Analyses (DPA). The therapist uses DPA at pre-intervention and throughout the sessions and mediational techniques to guide participants to use GOAL-PLAN-DO-CHECK to discover specific strategies to solve performance problems and to support generalization and transfer of skills.
Intervention Type
Behavioral
Intervention Name(s)
standard CO-OP Approach plus coaching parents
Other Intervention Name(s)
CO-OP Approach boosted
Intervention Description
CO-OP Approach with parents coaching groups will include an addition of four extra coaching groups sessions for parents to provide additional information to supplement their knowledge on CO-OP (how to use GOAL-PLAN-DO-CHECK at home; how to use dynamic performance analysis to support their children's' performance solutions; to talk about their experiences with their children at home).
Primary Outcome Measure Information:
Title
Changes on the Canadian Occupational Performance Measure (COPM)
Time Frame
Changes on perceived performance and satisfaction from baseline to 12 weeks; Changes on perceived performance and satisfaction from baseline to 24 weeks, and changes on perceived performance from post intervention to 24 weeks.
Title
Changes on frequency on the Participation and Environment Measure -Child and Youth (PEM-CY)
Time Frame
Changes on frequency levels of participation from baseline to 12 weeks; Changes on frequency levels of participation at baseline to 24 weeks, and changes on frequency levels of participation from post intervention to 24 weeks.
Title
Changes on involvement on the Participation and Environment Measure -Child and Youth (PEM-CY)
Time Frame
Changes on involvement levels of participation from baseline to 12 weeks; Changes on involvement levels of participation from baseline to 24 weeks, and changes on involvement levels of participation from post intervention to 24 weeks.
Title
Changes on the Performance Quality Rating Scale (PQRS)
Time Frame
Changes on actual performance from baseline to 12 weeks; Changes on actual performance from baseline to 24 weeks, and changes on actual performance from post intervention to 24 weeks.
Secondary Outcome Measure Information:
Title
Changes on Motor Assessment Battery for Children Second Edition (MABC2)
Time Frame
Changes on motor proficiency from baseline to 12 weeks.
Title
Changes on Five Digits Test (FDT)
Time Frame
Changes on Cognitive flexibility from baseline to 12 weeks.
Title
Changes on the Self-Perception Profile for children
Time Frame
Changes on self-perception from baseline to 12 weeks; Changes on self-perception from baseline to 24 weeks, and changes on self-perception from post intervention to 24 weeks.
Title
Changes on Tower of London Test (TOL)
Time Frame
Changes on mental planning from baseline to 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: score on MABC-2 below the 15th percentile; score on DCDQ-Brazil below age expectation, indicating problems on everyday living and/or academic skills; cognitive development within the expected age range according to the Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV); no diagnosis or signs of neurological or neuromuscular diseases. Exclusion Criteria: no reading ability; child refuses to participate on assessment sessions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Livia C Magalhaes, PhD
Organizational Affiliation
Federal Unversity of Minas Gerais
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
31270-901
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
26213242
Citation
Thornton A, Licari M, Reid S, Armstrong J, Fallows R, Elliott C. Cognitive Orientation to (Daily) Occupational Performance intervention leads to improvements in impairments, activity and participation in children with Developmental Coordination Disorder. Disabil Rehabil. 2016;38(10):979-86. doi: 10.3109/09638288.2015.1070298. Epub 2015 Jul 27.
Results Reference
background
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
11345513
Citation
Missiuna C, Mandich AD, Polatajko HJ, Malloy-Miller T. Cognitive orientation to daily occupational performance (CO-OP): part I--theoretical foundations. Phys Occup Ther Pediatr. 2001;20(2-3):69-81.
Results Reference
background
PubMed Identifier
11345506
Citation
Polatajko HJ, Mandich AD, Missiuna C, Miller LT, Macnab JJ, Malloy-Miller T, Kinsella EA. Cognitive orientation to daily occupational performance (CO-OP): part III--the protocol in brief. Phys Occup Ther Pediatr. 2001;20(2-3):107-23.
Results Reference
background
PubMed Identifier
19923975
Citation
Levac D, Wishart L, Missiuna C, Wright V. The application of motor learning strategies within functionally based interventions for children with neuromotor conditions. Pediatr Phys Ther. 2009 Winter;21(4):345-55. doi: 10.1097/PEP.0b013e3181beb09d.
Results Reference
background
PubMed Identifier
11345514
Citation
Polatajko HJ, Mandich AD, Miller LT, Macnab JJ. Cognitive orientation to daily occupational performance (CO-OP): part II--the evidence. Phys Occup Ther Pediatr. 2001;20(2-3):83-106.
Results Reference
background
PubMed Identifier
27522644
Citation
Capistran J, Martini R. Exploring inter-task transfer following a CO-OP approach with four children with DCD: A single subject multiple baseline design. Hum Mov Sci. 2016 Oct;49:277-90. doi: 10.1016/j.humov.2016.07.004. Epub 2016 Aug 12.
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
33845626
Citation
Araujo CRS, Cardoso AA, Magalhaes LC. Efficacy of CO-OP Approach With and Without Parental Coaching: RCT Study Protocol: Efficacite de l'approche CO-OP avec et sans coaching parental : protocole d'essai clinique randomise. Can J Occup Ther. 2021 Jun;88(2):182-194. doi: 10.1177/00084174211005889. Epub 2021 Apr 13.
Results Reference
derived

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Effects of CO-OP Approach on Activity and Participation of Brazilian Children With Developmental Coordination Disorder

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