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

Study Description

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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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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. ]

Eligibility Criteria

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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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

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.

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.

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.

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. Review.

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. Review.

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.

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.

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
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