Clinical trial NCT04560777: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Keywords: Cognitive Orientation to daily Occupational Performance
rehabilitation
executive functions
child acquired brain injury
teenagers
young adults
acquired brain injury
Lead sponsor: Hopitaux de Saint-Maurice
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Hôpital Civil de Strasbourg
name: Ministry of Health, France
First posted: 2020-09-23
Enrollment: 12
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single case experimental study design with multiple baselines across individuals and behaviors.

Randomization:

1. Which patient starts when the COOP sessions?
2. What are the possible starting points for the 3 goals to be worked on?
3. Which of the 4 goals ABCD is assigned to which goal number? The most important goal (A) will necessarily be worked on first. We will draw lots to determine the order in which the goals will be worked on and which goal will be designated as the control goal.
Primary purpose: OTHER

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).

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Diagnosis of acquired brain injury, for at least 6 months.
3. Child/adolescent/young adult presenting executive function deficits as determined by the neuropsychological assessment (standardized tests and/or questionnaire).
4. Vision and hearing normal or sufficient to communicate effectively (with appropriate correction if necessary).
5. Having sufficient speaking and comprehension skills to communicate effectively and accurately.
6. Enrollment in a Medicare plan or eligible beneficiary.
7. 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:

1. Non-Francophone child/teenager/young adult and/or non-Francophone parents.
2. 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.
3. Neurological, psychiatric, genetic or learning disorder diagnosed prior to the occurrence of the acquired brain injury.
4. Severe anxiety and/or depressive disorder diagnosed that is not compatible with participation in the study.
5. 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).
6. Major subject under guardianship or curatorship.

Primary outcomes:
measure: Assessment of Goal Attainment Scaling (GAS) change
timeFrame: 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)
Secondary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Before baseline, at immediate post-intervention, at 2, 4 and 6-months post-intervention.
measure: Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: 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.
measure: Évaluation des Pratiques Éducatives Parentales (EPEP, Parental Childrearing Behavior Scale for French-Speaking Parents, Children, and Adolescents)
timeFrame: one time before baseline
measure: Questionnaire Engagement des Proches
timeFrame: week 2, 4 and 6 during the intervention
measure: Entretien Engagement des Proches
timeFrame: immediate post-intervention, 4 and 6 months-post-intervention
Other outcomes:
Locations:
city: Neufmoutiers en Brie
country: France
facility: Centre Médical et Pédagogique pour Adolescents
city: Saint-Maurice
country: France
facility: Hôpitaux de Saint-Maurice
Study officials:
affiliation: Hopitaux de Saint-Maurice
name: Mathilde CHEVIGNARD, PhD
role: STUDY_DIRECTOR
References:
citation: Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
citation: Krasny-Pacini A, Hiebel J, Pauly F, Godon S, Chevignard M. Goal attainment scaling in rehabilitation: a literature-based update. Ann Phys Rehabil Med. 2013 Apr;56(3):212-30. doi: 10.1016/j.rehab.2013.02.002. Epub 2013 Feb 28.
citation: Scammell EM, Bates SV, Houldin A, Polatajko HJ. The Cognitive Orientation to daily Occupational Performance (CO-OP): A scoping review. Can J Occup Ther. 2016 Oct;83(4):216-225. doi: 10.1177/0008417416651277. Epub 2016 Jun 14.