NCT07085403Not yet recruiting
Let's CO-OPerate! Together we Are Stronger
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
Source: ClinicalTrials.gov · Last updated 13 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 4 Jul 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 1 May 2027
- Lead sponsor
- Hopitaux de Saint-Maurice
- Diseases
- Stroke
- NCT number
- NCT07085403
What you commit to
- Study type: Interventional
- Planned participants: 12
- From 1 Sept 2025 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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).
Age in the registry: 8 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpitaux Paris-Est Val-de-Marne Coordinator of this site? Confirm its status | Saint-Maurice | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.