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Clinical Trials/NCT04560777
NCT04560777
Completed
N/A

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

Hopitaux de Saint-Maurice2 sites in 1 country12 target enrollmentNovember 20, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acquired Brain Injury
Sponsor
Hopitaux de Saint-Maurice
Enrollment
12
Locations
2
Primary Endpoint
Assessment of Goal Attainment Scaling (GAS) change
Status
Completed
Last Updated
3 years ago

Overview

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 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).

Registry
clinicaltrials.gov
Start Date
November 20, 2020
End Date
July 27, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Hopitaux de Saint-Maurice
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Child/adolescent/young adult aged between 8 and 21 years old, hospitalized in the Acquired Neurological Pathologies Service of the Saint-Maurice Hospitals or in the Medical and Pedagogical Centre for Adolescents of Neufmoutiers-en-Brie, and possibly schooled in this service.
  • Diagnosis of acquired brain injury, for at least 6 months.
  • Child/adolescent/young adult presenting executive function deficits as determined by the neuropsychological assessment (standardized tests and/or questionnaire).
  • Vision and hearing normal or sufficient to communicate effectively (with appropriate correction if necessary).
  • Having sufficient speaking and comprehension skills to communicate effectively and accurately.
  • Enrollment in a Medicare plan or eligible beneficiary.
  • Agreement of the child/young person and informed consent expressed by the holders of parental authority. Consent of the young adult (18-21 years of age).

Exclusion Criteria

  • Non-Francophone child/teenager/young adult and/or non-Francophone parents.
  • With an intellectual disability (total IQ \<70), or severe impairment in comprehension, memory or attention, not compatible with understanding the goals of the rehabilitation and participation in 45-minute sessions.
  • Neurological, psychiatric, genetic or learning disorder diagnosed prior to the occurrence of the acquired brain injury.
  • Severe anxiety and/or depressive disorder diagnosed that is not compatible with participation in the study.
  • Inability to commit until the end of the CO-OP rehabilitation phase (e.g., planned relocation, planned hospital discharge before the end of the 14 CO-OP sessions, i.e., 10 weeks including baseline and CO-OP rehabilitation).
  • Major subject under guardianship or curatorship.

Outcomes

Primary Outcomes

Assessment of Goal Attainment Scaling (GAS) change

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)

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.

Secondary Outcomes

  • Questionnaire Engagement des Proches(week 2, 4 and 6 during the intervention)
  • Entretien Engagement des Proches(immediate post-intervention, 4 and 6 months-post-intervention)
  • Canadian Occupational Performance Measure (COPM)(Before baseline, 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)(one time before baseline)
  • Behavior Rating Inventory of Executive Function (BRIEF)(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.)

Study Sites (2)

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