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

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ClinicalTrials.gov Identifier: NCT02893852
Recruitment Status : Active, not recruiting
First Posted : September 9, 2016
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Clarice Ribeiro Soares Araujo, Federal University of Minas Gerais

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).

Condition or disease Intervention/treatment Phase
Motor Skills Disorders Attention Deficit and Disruptive Behavior Disorders Behavioral: standard CO-OP Approach Behavioral: standard CO-OP Approach plus coaching parents Not Applicable

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  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of the Cognitive Orientation to Daily Occupational Performance Approach on Activity and Participation of Brazilian Children With Developmental Coordination Disorder
Study Start Date : May 12, 2016
Actual Primary Completion Date : December 18, 2017
Estimated Study Completion Date : May 18, 2018

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.
Behavioral: standard CO-OP Approach
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 Name: 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.
Behavioral: standard CO-OP Approach plus coaching parents
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 Name: CO-OP Approach boosted




Primary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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 Measures :
  1. Changes on Motor Assessment Battery for Children Second Edition (MABC2) [ Time Frame: Changes on motor proficiency from baseline to 12 weeks. ]
  2. Changes on Five Digits Test (FDT) [ Time Frame: Changes on Cognitive flexibility from baseline to 12 weeks. ]
  3. 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. ]
  4. Changes on Tower of London Test (TOL) [ Time Frame: Changes on mental planning from baseline to 12 weeks. ]


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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893852


Locations
Brazil
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 31270-901
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Study Chair: Livia C Magalhaes, PhD Federal Unversity of Minas Gerais

Publications:

Responsible Party: Clarice Ribeiro Soares Araujo, Doctoral Candidate, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02893852     History of Changes
Other Study ID Numbers: CAAE54543216.3.0000.5149/1.520
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Motor Skills Disorders
Pathologic Processes
Neurodevelopmental Disorders
Behavioral Symptoms