Motor Skills DisordersNCT02893852
Effects of CO-OP Approach on Activity and Participation of Brazilian Children With Developmental Coordination Disorder
A study testing standard CO-OP Approach and standard CO-OP Approach plus coaching parents in people with Motor Skills Disorders and Attention Deficit and Disruptive Behavior Disorders, run by Federal University of Minas Gerais at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Motor Skills Disorders, Attention Deficit and Disruptive Behavior Disorders
- What is being tested?
- standard CO-OP Approach and standard CO-OP Approach plus coaching parents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteBrazil
- Study dates
- 12 May 2016to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- no reading ability;
- child refuses to participate on assessment sessions.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 31270-901
About this study
Official title: 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).
Read the 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.
- Being tested
- standard CO-OP Approach, standard CO-OP Approach plus coaching parents
- Medical subject headings
- Motor Skills Disorders, Attention Deficit and Disruptive Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard CO-OP ApproachBehavioural
Also called 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 parentsBehavioural
Also called CO-OP Approach boosted
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).
| Study group | Role | What they receive |
|---|---|---|
| standard CO-OP Approach | Active comparator | Task oriented and client-centred intervention with 12 sessions (10 interventional and 2 assessment sessions) with children and parents. Receives: Behavioral: standard CO-OP Approach |
| standard CO-OP Approach plus coaching parents | Experimental | 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. Receives: Behavioral: standard CO-OP Approach plus coaching parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on the Canadian Occupational Performance Measure (COPM)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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 outcomes (4)
Changes on Motor Assessment Battery for Children Second Edition (MABC2)
Measured: Changes on motor proficiency from baseline to 12 weeks.
Changes on Five Digits Test (FDT)
Measured: Changes on Cognitive flexibility from baseline to 12 weeks.
Changes on the Self-Perception Profile for children
Measured: 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)
Measured: Changes on mental planning from baseline to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start12 May 2016
- Primary completion18 Dec 2017
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Motor Skills DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clarice Ribeiro Soares Araujo, Federal University of Minas Gerais
- Investigators
- Livia C Magalhaes, PhD, Study chair, Federal Unversity of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893852
- Sponsor's protocol ID
- CAAE54543216.3.0000.5149/1.520
- Status last verified
- Feb 2019
- First submitted
- 31 Aug 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
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.
PubMed 26213242Miller 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.
PubMed 11471396Missiuna 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.
PubMed 11345513Polatajko 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.
PubMed 11345506Levac 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.
PubMed 19923975Polatajko 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.
PubMed 11345514Capistran 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.
PubMed 27522644Mandich 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.
PubMed 14624835Araujo 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.
PubMed 33845626
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Cognitive Orientation to Daily Occupational Performance Approach on Activity and Participation of Brazilian Children With Developmental Coordination Disorder
- ClinicalTrials.gov ID
- NCT02893852
- Acronym / sponsor ID
- CAAE54543216.3.0000.5149/1.520
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 12 May 2016
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard CO-OP Approach | Active comparator | Behavioral: standard CO-OP ApproachTask oriented and client-centred intervention with 12 sessions (10 interventional and 2 assessment sessions) with children and parents. |
| standard CO-OP Approach plus coaching parents | Experimental | Behavioral: standard CO-OP Approach plus coaching parentsTask 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- no reading ability;
- child refuses to participate on assessment sessions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard CO-OP ApproachAlso: CO-OP ApproachThe 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. | Behavioural | standard CO-OP Approach |
| standard CO-OP Approach plus coaching parentsAlso: CO-OP Approach boostedCO-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). | Behavioural | standard CO-OP Approach plus coaching parents |
Primary outcome
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 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 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 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.
4 secondary outcomes
Changes on Motor Assessment Battery for Children Second Edition (MABC2)
Time frame: 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 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 Tower of London Test (TOL)
Time frame: Changes on mental planning from baseline to 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Background: PubMed 26213242Thornton 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.
- Background: PubMed 11471396Miller 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.
- Background: PubMed 11345513Missiuna 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.
- Background: PubMed 11345506Polatajko 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.
- Background: PubMed 19923975Levac 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.
- Background: PubMed 11345514Polatajko 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.
- Background: PubMed 27522644Capistran 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.
- Background: PubMed 14624835Mandich 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.
- Derived from this study: PubMed 33845626Araujo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Livia C Magalhaes, PhD study chair
Federal Unversity of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard CO-OP Approach and standard CO-OP Approach plus coaching parents in people with Motor Skills Disorders and Attention Deficit and Disruptive Behavior Disorders, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02893852, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.