Developmental Coordination DisorderNCT03112746
Efficacy of the CO-OP Approach With Brazilian Children With Developmental Coordination Disorder
A study testing Cognitive Orientation to Daily Occupational Performance in people with Developmental Coordination Disorder, run by Federal University of Minas Gerais.
Trial summary
Children with Developmental Coordination Disorder (DCD) have difficulties performing daily activities which reflects negatively on participation, impacting their lives. To date, there are a number of interventions to improve performance of these children on activities they want or need to. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- Cognitive Orientation to Daily Occupational Performance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 26 Mar 2009to 26 Mar 2010
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- poor motor performance measured by a motor performance test (cut off score below the 15th percentile).
- poor performance on academic and daily living activities measured by the Developmental Coordination Disorder Questionnaire answered by the parents.
- attending regular education with no evidence of marked school delay (over a year).
- cognitive development within the expected age range according to the Wechsler Intelligence Scale for Children-Third Edition (WISC-III).
Who cannot join
- signs of neurological or neuromuscular disorder.
- presence of intellectual disability.
About this study
Official title: Efficacy of the Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach With Brazilian Children With Developmental Coordination Disorder
Children with Developmental Coordination Disorder (DCD) have difficulties performing daily activities which reflects negatively on participation, impacting their lives. To date, there are a number of interventions to improve performance of these children on activities they want or need to. In Brazil, there is little research on the efficacy of such approaches. Our main objective was to start a set of studies to examine the effects of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP Approach) protocol on occupational performance and satisfaction of Brazilian children who have DCD; to examine whether children were able to transfer strategies and skills learned during CO-OP to untrained goals.
Read the detailed description
Background. Children with Developmental Coordination Disorder (DCD) have difficulties performing daily activities which reflects negatively on participation, impacting their lives. Objectives. To examine the effects of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP Approach) protocol on occupational performance and satisfaction of Brazilian children who have DCD; to examine whether children were able to transfer strategies and skills learned during CO-OP to untrained goals. Methods. A pre-post group comparison design with eight boys aged 6-10 years old. Children participated in 12 CO-OP sessions with their parents twice a week, with an extra session added to the protocol for parents´ orientation. The Canadian Occupational Performance Measure and the Performance Quality Rating Scale were used as outcome measures.
- Conditions
- Developmental Coordination Disorder
- Being tested
- Cognitive Orientation to Daily Occupational Performance
- Keywords
- child, goal, intervention, motor skills disorder, occupational therapy
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Orientation to Daily Occupational PerformanceBehavioural
Also called CO-OP Approach
In CO-OP Approach, therapists use mediational techniques to teach cognitive strategies - GOAL, PLAN, DO, CHECK - to improve occupational performance in goals chosen by the children in collaboration with them and their parents.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Orientation to daily Occupational Performance | Experimental | One group was submitted to the CO-OP approach to learn cognitive strategies to perform the chosen tasks. Receives: Behavioral: Cognitive Orientation to Daily Occupational Performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure
Change on performance and satisfaction on goals chosen by each child
Measured: up to 12 weeks
Performance Quality Rating Scale
Change on occupational performance on goals chosen by each child as measured by external evaluators
Measured: up 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 posted13 Apr 2017
- Study start26 Mar 2009
- Primary completion10 Feb 2010
- Study completion26 Mar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Developmental Coordination DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112746
- Sponsor's protocol ID
- COEP/UFMG ETIC Nº 103/2009
- Status last verified
- Apr 2017
- First submitted
- 2 Apr 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11471396Mandich AD, Polatajko HJ, Macnab JJ, Miller LT. Treatment of children with Developmental Coordination Disorder: what is the evidence? Phys Occup Ther Pediatr. 2001;20(2-3):51-68.
PubMed 11345512Mandich 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 14624835Green D, Chambers ME, Sugden DA. Does subtype of developmental coordination disorder count: is there a differential effect on outcome following intervention? Hum Mov Sci. 2008 Apr;27(2):363-82. doi: 10.1016/j.humov.2008.02.009. Epub 2008 Apr 8.
PubMed 18400322Carswell A, McColl MA, Baptiste S, Law M, Polatajko H, Pollock N. The Canadian Occupational Performance Measure: a research and clinical literature review. Can J Occup Ther. 2004 Oct;71(4):210-22. doi: 10.1177/000841740407100406.
PubMed 15586853Araujo CRS, Cardoso AA, Magalhaes LC. Efficacy of the cognitive orientation to daily occupational performance with Brazilian children with developmental coordination disorder. Scand J Occup Ther. 2019 Jan;26(1):46-54. doi: 10.1080/11038128.2017.1417476. Epub 2017 Dec 20.
PubMed 29260603
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach With Brazilian Children With Developmental Coordination Disorder
- ClinicalTrials.gov ID
- NCT03112746
- Acronym / sponsor ID
- COEP/UFMG ETIC Nº 103/2009
- Conditions
- Developmental Coordination Disorder
- Keywords
- child, goal, intervention, motor skills disorder, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 26 Mar 2009 (actual)
- Primary completion
- 10 Feb 2010 (actual)
- Study completion
- 26 Mar 2010 (actual)
- First posted
- 13 Apr 2017 (actual)
- 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.
Children with Developmental Coordination Disorder (DCD) have difficulties performing daily activities which reflects negatively on participation, impacting their lives. To date, there are a number of interventions to improve performance of these children on activities they want or need to. In Brazil, there is little research on the efficacy of such approaches. Our main objective was to start a set of studies to examine the effects of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP Approach) protocol on occupational performance and satisfaction of Brazilian children who have DCD; to examine whether children were able to transfer strategies and skills learned during CO-OP to untrained goals.
Detailed description
Background. Children with Developmental Coordination Disorder (DCD) have difficulties performing daily activities which reflects negatively on participation, impacting their lives. Objectives. To examine the effects of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP Approach) protocol on occupational performance and satisfaction of Brazilian children who have DCD; to examine whether children were able to transfer strategies and skills learned during CO-OP to untrained goals. Methods. A pre-post group comparison design with eight boys aged 6-10 years old. Children participated in 12 CO-OP sessions with their parents twice a week, with an extra session added to the protocol for parents´ orientation. The Canadian Occupational Performance Measure and the Performance Quality Rating Scale were used as outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Orientation to daily Occupational Performance | Experimental | Behavioral: Cognitive Orientation to Daily Occupational PerformanceOne group was submitted to the CO-OP approach to learn cognitive strategies to perform the chosen tasks. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- poor motor performance measured by a motor performance test (cut off score below the 15th percentile).
- poor performance on academic and daily living activities measured by the Developmental Coordination Disorder Questionnaire answered by the parents.
- attending regular education with no evidence of marked school delay (over a year).
- cognitive development within the expected age range according to the Wechsler Intelligence Scale for Children-Third Edition (WISC-III).
Key exclusion criteria (2 listed)
- signs of neurological or neuromuscular disorder.
- presence of intellectual disability.
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 |
|---|---|---|
| Cognitive Orientation to Daily Occupational PerformanceAlso: CO-OP ApproachIn CO-OP Approach, therapists use mediational techniques to teach cognitive strategies - GOAL, PLAN, DO, CHECK - to improve occupational performance in goals chosen by the children in collaboration with them and their parents. | Behavioural | Cognitive Orientation to daily Occupational Performance |
Primary outcome
Canadian Occupational Performance Measure
Time frame: up to 12 weeks
Change on performance and satisfaction on goals chosen by each child
Performance Quality Rating Scale
Time frame: up to 12 weeks
Change on occupational performance on goals chosen by each child as measured by external evaluators
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 13 Apr 2017.
- 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 11345512Mandich AD, Polatajko HJ, Macnab JJ, Miller LT. Treatment of children with Developmental Coordination Disorder: what is the evidence? Phys Occup Ther Pediatr. 2001;20(2-3):51-68.
- 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.
- Background: PubMed 18400322Green D, Chambers ME, Sugden DA. Does subtype of developmental coordination disorder count: is there a differential effect on outcome following intervention? Hum Mov Sci. 2008 Apr;27(2):363-82. doi: 10.1016/j.humov.2008.02.009. Epub 2008 Apr 8.
- Background: PubMed 15586853Carswell A, McColl MA, Baptiste S, Law M, Polatajko H, Pollock N. The Canadian Occupational Performance Measure: a research and clinical literature review. Can J Occup Ther. 2004 Oct;71(4):210-22. doi: 10.1177/000841740407100406.
- Derived from this study: PubMed 29260603Araujo CRS, Cardoso AA, Magalhaes LC. Efficacy of the cognitive orientation to daily occupational performance with Brazilian children with developmental coordination disorder. Scand J Occup Ther. 2019 Jan;26(1):46-54. doi: 10.1080/11038128.2017.1417476. Epub 2017 Dec 20.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Orientation to Daily Occupational Performance in people with Developmental Coordination Disorder, run by Federal University of Minas Gerais.
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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Canadian Occupational Performance Measure (time frame: up to 12 weeks). The study lists 2 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 NCT03112746, which also lists 6 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 13 Apr 2017.