Trials / Completed
CompletedNCT04560777
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Hopitaux de Saint-Maurice · Academic / Other
- Sex
- All
- Age
- 8 Years – 21 Years
- Healthy volunteers
- Not accepted
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 members/caregivers 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 members/caregivers.
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | CO-OP intervention | The general structure of the intervention will follow the original key principles of CO-OP, with some adjustments to adapt it to the specificities of the ABI population (14 CO-OP sessions vs 10 in the original protocol). The global strategy will be taught to the participant at the first session. The following sessions will be consisted of an process of implementation of the global strategy in the context of guided discovery to identify domain specific strategies to overcome performance ''breakdowns" the participant will be experiencing when performing the self-selected tasks. In addition, "homework" will be assigned to encourage the application and practice of the cognitive strategies discovered during the intervention sessions. Parents will be invited to attend the sessions if it will be possible for them. In any case, the global strategy, as well as the progress of the child, will be explained to the parents. |
Timeline
- Start date
- 2020-11-20
- Primary completion
- 2022-07-27
- Completion
- 2022-07-27
- First posted
- 2020-09-23
- Last updated
- 2022-07-28
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04560777. Inclusion in this directory is not an endorsement.