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

February 12, 2019 updated by: Clarice Ribeiro Soares Araujo, Federal University of Minas Gerais

Effects of the Cognitive Orientation to Daily Occupational Performance Approach on Activity and Participation of Brazilian Children With Developmental Coordination Disorder

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).

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 31270-901
        • Federal University of Minas Gerais

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

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard CO-OP Approach
Task oriented and client-centred intervention with 12 sessions (10 interventional and 2 assessment sessions) with children and parents.
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.
Other Names:
  • CO-OP Approach
Experimental: standard CO-OP Approach plus coaching 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.
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).
Other Names:
  • CO-OP Approach boosted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
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.
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.
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.
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.
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 Measures

Outcome Measure
Time Frame
Changes on Motor Assessment Battery for Children Second Edition (MABC2)
Time Frame: Changes on motor proficiency from baseline to 12 weeks.
Changes on motor proficiency from baseline to 12 weeks.
Changes on Five Digits Test (FDT)
Time Frame: Changes on Cognitive flexibility from baseline to 12 weeks.
Changes on Cognitive flexibility from baseline to 12 weeks.
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.
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.
Changes on Tower of London Test (TOL)
Time Frame: Changes on mental planning from baseline to 12 weeks.
Changes on mental planning from baseline to 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Livia C Magalhaes, PhD, Federal Unversity of Minas Gerais

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

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

May 12, 2016

Primary Completion (Actual)

December 18, 2017

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

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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