Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04560777
Status:
COMPLETED
Last Update Posted:
2022-07-28
First Post:
2020-09-15
Brief Title:
Exploring the Use of the Cognitive Orientation to Daily Occupational Performance Approach CO-OP With Children Teenagers and Young Adults With Executive Functions Deficits Following Severe Acquired Brain Injury
Sponsor:
Hopitaux de Saint-Maurice
Organization:
Hopitaux de Saint-Maurice
Study Overview
Official Title:
Exploring the Use of the Cognitive Orientation to Daily Occupational Performance Approach CO-OP With Children Teenagers and Young Adults With Executive Functions Deficits Following Severe Acquired Brain Injury
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REFECO-OP
Brief Summary:
Acquired brain injury ABI in childhood are the cause of disabling motor cognitive and behavioural disorders with severe consequences on the later development of autonomy and learning with long-term repercussions on independence for activities of daily living and social and professional integration
Among cognitive disorders executive function EF deficits are among the most frequent and disabling with major consequences on the development of autonomy and the course of schooling and learning
The Cognitive Orientation to daily Occupational Performance CO-OP could be an interesting approach for the rehabilitation of these consequences CO-OP is a performance-based treatment approach for children and adults who experience difficulties performing the skills they want to need to or are expected to perform CO-OP is a specifically tailored active client-centered approach that engages the individual at the meta-cognitive level to solve performance problems Focused on enabling success the CO-OP approach employs collaborative goal setting dynamic performance analysis cognitive strategy use guided discovery and enabling principles
It has been shown to be effective in a variety of populations but has been little explored in children with ABI The hypothesis that CO-OP is effective in improving the occupational performance and executive functioning of these children on a daily basis is emerging but needs to be confirmed This study falls within this framework
Primary objective
1 To measure the distance maintenance of the knowledge acquired through rehabilitation as well as the generalization and transfer into everyday life
1 Maintenance of acquired knowledge
2 Generalization and transfer
3 Impact of a consolidation session on generalization and transfer
Secondary objectives
2 Gather the experience of family memberscaregivers in accompanying their child in the CO-OP process outside of rehabilitation sessions
3 Establish the parental educational style and identify whether there is a link between the parental educational style and the commitment of the family memberscaregivers
Among cognitive disorders executive function EF deficits are among the most frequent and disabling with major consequences on the development of autonomy and the course of schooling and learning
The Cognitive Orientation to daily Occupational Performance CO-OP could be an interesting approach for the rehabilitation of these consequences CO-OP is a performance-based treatment approach for children and adults who experience difficulties performing the skills they want to need to or are expected to perform CO-OP is a specifically tailored active client-centered approach that engages the individual at the meta-cognitive level to solve performance problems Focused on enabling success the CO-OP approach employs collaborative goal setting dynamic performance analysis cognitive strategy use guided discovery and enabling principles
It has been shown to be effective in a variety of populations but has been little explored in children with ABI The hypothesis that CO-OP is effective in improving the occupational performance and executive functioning of these children on a daily basis is emerging but needs to be confirmed This study falls within this framework
Primary objective
1 To measure the distance maintenance of the knowledge acquired through rehabilitation as well as the generalization and transfer into everyday life
1 Maintenance of acquired knowledge
2 Generalization and transfer
3 Impact of a consolidation session on generalization and transfer
Secondary objectives
2 Gather the experience of family memberscaregivers in accompanying their child in the CO-OP process outside of rehabilitation sessions
3 Establish the parental educational style and identify whether there is a link between the parental educational style and the commitment of the family memberscaregivers
Detailed Description:
Twelve participants will be included aged 8 to 21 years old Participants will have different assessment times before during and after the CO-OP intervention immediate post-intervention 2 4 and 6-months post-intervention Parents will be asked to answer questionnaires and interview and to participate in certain CO-OP sessions if they can
They will choose four objectives problematic everyday life activities they want to improve Three will be worked on in CO-OP sessions the fourth will be the control objective
The duration of the baseline as well as the order of introduction of the objectives and the starting point of the objectives are randomized
Participants will have 14 sessions of rehabilitation with the CO-OP approach 2 sessions per week for 7 weeks
They will choose four objectives problematic everyday life activities they want to improve Three will be worked on in CO-OP sessions the fourth will be the control objective
The duration of the baseline as well as the order of introduction of the objectives and the starting point of the objectives are randomized
Participants will have 14 sessions of rehabilitation with the CO-OP approach 2 sessions per week for 7 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None