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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02893852
Other study ID # CAAE54543216.3.0000.5149/1.520
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 12, 2016
Est. completion date January 31, 2019

Study information

Verified date February 2019
Source Federal University of Minas Gerais
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date January 31, 2019
Est. primary completion date December 18, 2017
Accepts healthy volunteers No
Gender All
Age group 7 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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).

Locations

Country Name City State
Brazil Federal University of Minas Gerais Belo Horizonte Minas Gerais

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes on the Canadian Occupational Performance Measure (COPM) 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.
Primary Changes on frequency on the Participation and Environment Measure -Child and Youth (PEM-CY) 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.
Primary Changes on involvement on the Participation and Environment Measure -Child and Youth (PEM-CY) 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.
Primary Changes on the Performance Quality Rating Scale (PQRS) 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 Changes on Motor Assessment Battery for Children Second Edition (MABC2) Changes on motor proficiency from baseline to 12 weeks.
Secondary Changes on Five Digits Test (FDT) Changes on Cognitive flexibility from baseline to 12 weeks.
Secondary Changes on the Self-Perception Profile for children 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.
Secondary Changes on Tower of London Test (TOL) Changes on mental planning from baseline to 12 weeks.
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