Let's CO-OPerate! Together we Are Stronger

Official title

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

Overview

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.

Interventions

• Other Cognitive Orientation to daily Occupational Performance (CO-OP) is a cognitive problem-solving approach
  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 performa

Primary outcome measures

• Goal Attainment Scale (GAS) [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.]

Secondary outcome measures (3)

• Canadian Occupational Performance Measure (COPM) [Time frame: Once before baseline, at immediate post-intervention, at 2, 4 and 6-months post-intervention.]
• Behavior Rating Inventory of Executive Function questionnaire (BRIEF) [Time frame: twice in baseline, once in immediate post-intervention and once at 2,4,6 month post-intervention.]
• Entretien Engagement des Proches [Time frame: once at immediate post-intervention, 4 and 6 months-post-intervention]]

Eligibility criteria

Inclusion criteria

• Children/adolescents (8-16 years old) with coordination disorders and/or executive function deficits, following a acquired brain injury more than 3 months ago or a congenital brain lesion or a neurodevelopmental disorder.
• Executive function deficits as assessed by neuropsychological tests (standardised tests and/or questionnaires) and/or coordination disorders as assessed by neuropsychological tests (standardised tests and/or questionnaires).
• Vision and hearing normal or sufficient to communicate effectively (with appropriate correction where necessary).
• Cognitive, behavioural and expressive/receptive communication skills enabling them to identify goals and participate actively in the CO-OP intervention process.
• Membership of a health insurance scheme or beneficiary.
• Agreement of the child/adolescent and informed consent expressed by at least one of the holders of parental authority.

Non-inclusion criteria :

• Children/adolescents who do not meet the inclusion criteria.
• Children/adolescents and/or parents non-French-speaking.
• Presenting intellectual difficulties, or severe problems of comprehension, memory or attention, as described in the CO-OP recommendations.
• A diagnosed severe anxiety-depressive disorder that is not compatible with participation in the study.
• Inability to remain involved until the end of the CO-OP intervention phase (e.g. planned move).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• Hôpitaux Paris-Est Val-de-Marne — Saint-Maurice

Publications

• Steenbeek D, Ketelaar M, Galama K, Gorter JW. Goal Attainment Scaling in paediatric rehabilitation: a report on the clinical training of an interdisciplinary team. Child Care Health Dev. 2008 Jul;34(4):521-9. doi: 10.1111/j.1365-2214.2008.00841.x. PMID 19154553
• Polatajko HJ, Mandich AD, Missiuna C, Miller LT, Macnab JJ, Malloy-Miller T, Kinsella EA. Cognitive orientation to daily occupational performance (CO-OP): part III--the protocol in brief. Phys Occup Ther Pediatr. 2001;20(2-3):107-23. PMID 11345506

Identifiers

NCT: NCT07085403 · COOPerons - PR- 2024 - 7

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗