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

NCT ID: NCT02893852

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-12

Study Completion Date

2019-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Motor Skills Disorders Attention Deficit and Disruptive Behavior Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

standard CO-OP Approach

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

Group Type ACTIVE_COMPARATOR

standard CO-OP Approach

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

standard CO-OP Approach plus coaching parents

Intervention Type BEHAVIORAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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).

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CO-OP Approach CO-OP Approach boosted

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Clarice Ribeiro Soares Araujo

Doctoral Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Livia C Magalhaes, PhD

Role: STUDY_CHAIR

Federal Unversity of Minas Gerais

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26213242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11471396 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11345513 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11345506 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19923975 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11345514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27522644 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14624835 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33845626 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CAAE54543216.3.0000.5149/1.520

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Let's CO-OPerate! Together we Are Stronger
NCT07085403 NOT_YET_RECRUITING NA