Let's CO-OPerate! Together we Are Stronger

NCT ID: NCT07085403

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-05-01

Brief Summary

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.

Conditions

Executive Function Deficits (EFD); Developmental Coordination Disorder; Acquired Brain Injury (Including Stroke); Brain Injury, Fetus and Neonate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

COOP experimental arm

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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.

Interventions

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 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.

Intervention Type: OTHER

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.

• 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).

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopitaux de Saint-Maurice

OTHER

Sponsor Role: lead

Responsible Party

Hélène LEBRAULT

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hôpitaux Paris-Est Val-de-Marne

Saint-Maurice, Île-de-France Region, France

Countries

France

Central Contacts

Helene LEBRAULT, OT, PhD

Role: CONTACT

helene.lebrault@ght94n.fr

+0033143966682

Facility Contacts

Helene LEBRAULT, OT, PhD

Role: primary

helene.lebrault@ght94n.fr

+0033607659198

References

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.

Reference Type: BACKGROUND

PMID: 19154553 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11345506 (View on PubMed)

Other Identifiers

COOPerons - PR- 2024 - 7

Identifier Type: -

Identifier Source: org_study_id