Hôpitaux Paris-Est Val-de-Marne
Saint-Maurice, Île-de-France Region, 94410, France
NCT Number: NCT07085403
The goal of this replicated single case experimental study using a randomized multiple baseline design across participants and goals is to enable children/adolescents (aged 8-16 years) with developmental coordination disorders and/or executive function deficits following an acquired or congenital brain injury, to achieve their occupational goals. The aim is to make them more independents and autonomous in their daily lives. To achieve this, we're going to offer them an intensive group CO-OP (Cognitive Orientation to daily Occupational Performance Approach) rehabilitation training, and actively involving the parents. The main questions it aims to answer are:
* To evaluate the improvement in occupational performance* (and its maintenance over time) following intervention using the CO-OP Approach.
*Occupational performance is a person's ability to choose, organize and engage in meaningful occupations that give them satisfaction. These occupations, determined by culture and corresponding to their age group, enable them to take care of themselves, have fun and contribute to the social and economic fabric of the community. * To gather parents' experiences of supporting their child during the CO-OP intervention and its follow-up phase.
Participants will be asked to identify 3 goals that they would like to achieve with the CO-OP Approach. The CO-OP intervention will take the form of two half-days a week for 5 weeks, with 1 hour 30 minutes of individual CO-OP sessions and 1 hour 30 minutes of group sessions.
Trial opening soon.
Get Notified8 year–16 year
All sexes
Interventional
Not applicable
Saint-Maurice, Île-de-France Region, 94410, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-inclusion criteria :
Cognitive Orientation to daily Occupational Performance (CO-OP; CO-OP approach) 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. These elements, all considered essential to the CO-OP Approach, are situated within a structured intervention format, and may involve the parent/significant other as appropriate.
Time frame: Baseline to 6-months post-intervention: two times per week during baseline and intervention phase for each chosen-goal ; one time at 2, 4 and 6-months post-intervention.
The Goal Attainment Scale (GAS) is a criterion--referenced measure used to quantify the degree to which personal goals are achieved. GAS methodology consists in:
Time frame: Once before baseline, at immediate post-intervention, at 2, 4 and 6-months post-intervention.
The Canadian Occupational Performance Measure is an individualized, client--centered, semi--structured interview used to identify occupational performance issues.For each performance issue, perceived performance and satisfaction are scored on a 1 to 10 Likert scale.
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.
For each self--identified goal, four different COPM ratings will be obtained: (1) the participant's perceived occupational performance rating; (2) the participant's satisfaction rating; (3) the parent's perceived occupational performance rating; (4) the parent's satisfaction rating.
Time frame: twice in baseline, once in immediate post-intervention and once at 2,4,6 month post-intervention.
The Behavior Rating Inventory of Executive Function questionnaire (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: once at immediate post-intervention, 4 and 6 months-post-intervention]
The aim 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: Once before the baseline for children aged 8-15 years
Behavioural Assessment of the Dysexecutive Syndrome for Children (BADS-C) predicts everyday problems associated with a major area of cognitive deficit that can impede functional recovery and the ability to respond to rehabilitation programs. The therapist can be use 2 subtests to assess the executive functions deficits (Zoo Part 1 and 2 subtest; Six parts subtest). Standard scores: mean 10 (SD: 3).
Time frame: Once before the baseline for participants aged 16 years
Behavioural Assessment of the Dysexecutive Syndrome (BADS) predicts everyday problems associated with a major area of cognitive deficit that can impede functional recovery and the ability to respond to rehabilitation programs. The therapist can be use 2 subtests to assess the executive functions deficits (Zoo Part 1 and 2 subtest; Six elements subtest). Standard scores : means 10 (SD: 3).
Time frame: once before the baseline
The M-ABC is designed to identify and describe impairments in motor performance of children and adolescents. It will be use to assess developmental coordination disorders. Standard scores: mean 10 (3).
Time frame: once before the baseline
Wechsler Intelligence Scale for Children is an intelligence test that measures a child's intellectual ability and 5 cognitive domains that impact performance. This test (or equivalent, depending on the neuropsychologist's decision) will be used to assess development coordination disorders and/or executive function deficits. Standard scores for index: mean 100 (SD: 15); Standard scores for subtests: mean 10 (SD: 3).
Time frame: once before the baseline
The Children's Cooking Task (CCT) is a complex test that has been specifically developed to assess executive functions in a standardized open-ended environment (cooking). The CCT can be used by therapists to assess executive function deficits. Number of errors / z score (compared to age-matched controls); Task duration (min) / z score (compared to age-matched controls).
Contact information is provided by the study sponsor or research team.
Hopitaux de Saint-Maurice
Other
Let's CO-OPerate! Together we Are Stronger: Exploring the Effectiveness of the CO-OP Cognitive Problem-solving Approach in the Context of an Intensive Group Rehabilitation Training for a Paediatric Population With Executive Function Deficits and/or Developmental Coordination Disorders Following Brain Injury
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