Clinical trial NCT04718688: Exploring the Use of the CO-OP With Children With EF Functions Deficits Following ABI
Official title: Exploring the Use of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP) With Children With Executive Functions Deficits Following Severe Acquired Brain Injury: a Single Case Experimental Design Study
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
occupational performance
Lead sponsor: Hopitaux de Saint-Maurice
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 2
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single case experimental study design (SCED) with multiple baselines across individuals and behaviors
Primary purpose: OTHER

Brief summary: Purpose:

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.

Objectives To assess whether the use of CO-OP could be of interest in children with executive functions deficits following ABI, to improve their occupational performance, their executive functioning in everyday life and their cognitive processes constituting EF.

Detailed description: Method

* Single case experimental study with multiple baselines across individuals and behaviors
* 14 individual sessions of CO-OP intervention.
* Two goals trained, one control goal.
* Different assessments used : Canadian Occupational Performance Measure (COPM), the Goal Attainment Scales (GAS), the Children's Cooking Task (CCT) and parent- and teacher-ratings of the Behavior Rating Inventory of Executive Functions (BRIEF) questionnaire.

Eligibility criteria: Inclusion criteria were:

* Age 8 to 14 years
* Diagnosis of ABI, sustained at least 6 months previously, still attending an in- or outpatient rehabilitation program following injury
* Evidence of a dysexecutive syndrome on the neuropsychological assessment
* Normal vision and hearing (with appropriate correction if necessary)
* Sufficient language skills to understand and to communicate explicitly

Exclusion criteria were:

* Non-French-speaking child or parents
* Sensory-motor or visual impairments precluding participation in the study
* Intellectual deficit (Full-Scale Intellectual Quotient (IQ)\<70), or severe impairments in comprehension, memory or attention, incompatible with understanding and choosing rehabilitation goals and participating in 45-minutes sessions
* Neurological, psychiatric, genetic or learning disability diagnosed prior to the ABI
* Severe anxiety or depression symptoms

Primary outcomes:
measure: Assessment of Goal Attainment Scaling (GAS) change
timeFrame: Baseline to 3-months post-intervention (Three times per week during baseline and intervention phase for each 3 chosen-goal ; one time at 3-months post-intervention)
Secondary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Before baseline, at immediate post-intervention, at 3-months post-intervention.
measure: Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: Three times during baseline, at immediate post-intervention, at 1- and 3-months post-intervention
measure: Children's cooking task
timeFrame: pre-intervention, immediate post-intervention and 3-months post-intervention
Other outcomes:
Locations:
city: Saint-Maurice
country: France
facility: Saint Maurice Hospitals
Study officials:
affiliation: Hopitaux de Saint-Maurice
name: Helene LEBRAULT, Mec
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lebrault H, Chavanne C, Abada G, Latinovic B, Varillon S, Bertrand AF, Oudjedi E, Krasny-Pacini A, Chevignard M. Exploring the use of the Cognitive Orientation to daily Occupational Performance approach (CO-OP) with children with executive functions deficits after severe acquired brain injury: A single case experimental design study. Ann Phys Rehabil Med. 2021 Sep;64(5):101535. doi: 10.1016/j.rehab.2021.101535. Epub 2021 Jul 17.