An interventional study of CO-OP intervention in Acquired Brain Injury, sponsored by Hopitaux de Saint-Maurice. Completed at 2 sites in France. Open to participants aged 8 Years to 21 Years. Per ClinicalTrials.gov, last updated 2022-07-28.
Sponsored by Hopitaux de Saint-Maurice · Not applicable, Interventional, and Other
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:
To measure the distance maintenance of the knowledge acquired through rehabilitation, as well as the generalization and transfer into everyday life.
Secondary objectives:
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).
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 12 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Hopitaux de Saint-Maurice is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CO-OP intervention
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.
Assessment of Goal Attainment Scaling (GAS) change
Goal Attainment Scaling (GAS) is a method for writing personalized evaluation scales in order to quantify progress toward defined goals. GAS methodology consists in: * Defining a rehabilitation goal; * Choosing an observable behaviour that reflects the degree of goal attainment; * Defining the patient's initial level with respect to the goal; * Defining five goal attainment levels (ranging from a ''no change'' to a ''much better than expected outcome''); * Evaluating the patient after a defined time interval; * Calculating the overall attainment score for all the rehabilitation goals. A five-point scale is used: ''-2'' is the initial pretreatment (baseline) level, ''-1'' represents progression towards the goal without goal attainment, ''0'' is the expected level after treatment, (and therefore, the ''most likely'' level after treatment), ''+1'' represents a better outcome than expected, and ''+2'' is the best possible outcome that could have been expected for this goal.
Time frame: Baseline to 6-months post-intervention (Two times per week during baseline and intervention phase for each 4 chosen-goal ; one time at 2, 4 and 6-months post-intervention)
Canadian Occupational Performance Measure (COPM)
This semi-structured interview helps children/parents identify problematic occupations in different daily areas. COPM will be used: (1) To determine (only with the child) the 4 problematic occupations identified as the most important (3 will be used as target goals, while the 4 will serve as a control goal); (2) To determine changes in occupational performance in self-selected goals: children and parents will rated their performance and satisfaction associated with these 4 occupations. Performance and satisfaction are rated by children and parents on a scale of 1 to 10 (1= not at all able to perform the activity (performance) / not at all satisfied with the way the activity is performed (satisfaction); 10 = perfectly able to perform the activity (performance) / perfectly satisfied with the way the activity is performed (satisfaction). A difference of 2 points between pre- and post-intervention is clinically significant.
Time frame: Before baseline, at immediate post-intervention, at 2, 4 and 6-months post-intervention.
Behavior Rating Inventory of Executive Function (BRIEF)
The parent and teacher report forms of the Behavior Rating Inventory of Executive Function (BRIEF, or BRIEF-A for adults'version) provide an ecological assessment of executive functioning through its repercussions in family and school context. Currently, this questionnaire is the best validated and most widely used in children in various congenital, developmental or acquired conditions. The outcome measure is the Global Executive Composite score (GEC) T-Scores (Mean: 50; SD: 10; clinical range cutoff: T-Scores≥65).
Time frame: Minimum 3-maximum 6 assessments during the baseline (according the duration of the baseline), week 2, 4 and 6 during the intervention, at immediate post-intervention, at 2, 4 and 6-months post-intervention.
Évaluation des Pratiques Éducatives Parentales (EPEP, Parental Childrearing Behavior Scale for French-Speaking Parents, Children, and Adolescents)
The EPEP represents an efficient solution to the search for conceptually and psychometrically sound instruments to assess parents' child-rearing behavior. A 5-point Likert-type scale is provided for each item ranging from "never" "to always" (explaining to parents that there are no right or wrong answers). The results are obtained by averaging the scores per subscale (8 subscales). The purpose of this evaluation is to define the parenting educational style: there are not a better or worse outcome per se.
Time frame: one time before baseline
Questionnaire Engagement des Proches
The objective of this questionnaire is to collect information on the use of CO-OP by family caregivers with the participant, outside of rehabilitation sessions. No scale of score, just a collection of factual facts.
Time frame: week 2, 4 and 6 during the intervention
Entretien Engagement des Proches
The objective of this interview is to collect information on the experience of use of CO-OP by family caregivers with the participant, outside of rehabilitation sessions. No scale of score, the interviews will be analyzed according to a qualitative description.
Time frame: immediate post-intervention, 4 and 6 months-post-intervention
Plan to share: Undecided — We think it would be interesting to share the IPD with other researchers (especially Canadian researchers), but we have not yet defined the terms of this sharing.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Hopitaux de Saint-Maurice