Let's CO-OPerate! Together we Are Stronger

NCT07085403 | Not Yet Recruiting

• 1 other identifier: COOPerons - PR- 2024 - 7
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

paediatric rehabilitation; occupational therapy; executive function deficits; developmental coordination disorder; acquired brain injury; fetus and neonate brain injury; Cognitive Orientation to daily Occupational Performance (CO--OP); intensive training; individual and group rehabilitation

Outcome Measures

Primary Outcomes (1)

• Goal Attainment Scale (GAS)

  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: * Defining a rehabilitation goal; * Choosing an observable behaviour that reflects the degree of goal attainment; * Defining the patient's initial level with respect to the goal; * Ranging from a ''no change'' to a ''much better than expected outcome''); * Evaluating the patient after a defined time interval; * Calculating the overall attainment score for all the rehabilitation goals. A five-point scale will be used: "-2" is the initial pretreatment level; "-1" represents progression towards the goal without goal attainment; ''0'' is the expected level after treatment, (and therefore, the ''most likely'' level after treatment); ''+1'' represents a better outcome than expected; ''+2'' is the best possible outcome that could have been expected for this goal.

  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 Outcomes (3)

• Canadian Occupational Performance Measure (COPM)

  Once before baseline, at immediate post-intervention, at 2, 4 and 6-months post-intervention.

• Behavior Rating Inventory of Executive Function questionnaire (BRIEF)

  twice in baseline, once in immediate post-intervention and once at 2,4,6 month post-intervention.

• Entretien Engagement des Proches

  once at immediate post-intervention, 4 and 6 months-post-intervention]

Other Outcomes (5)

• Behavioural Assessment of the Dysexecutive Syndrome for Children (BADS-C) (aged 8-- 15 years)

  Once before the baseline for children aged 8-15 years

• Behavioural Assessment of the Dysexecutive Syndrome (BADS) (participants aged 16 years)

  Once before the baseline for participants aged 16 years

• Movement Assessment Battery for Children (M-ABC)

  once before the baseline

Study Arms (1)

COOP experimental arm

EXPERIMENTAL

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

Interventions

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

COOP experimental arm

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

Sponsors & Collaborators

• Hopitaux de Saint-Maurice: lead

Study Sites (1)

Hôpitaux Paris-Est Val-de-Marne

Saint-Maurice, Île-de-France Region, 94410, France

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Motor Skills Disorders; Brain Injuries

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Helene LEBRAULT, OT, PhD

CONTACT

+0033143966682; helene.lebrault@ght94n.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: replicated single case experimental study using a randomized multiple baseline design across participants and goals

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 25, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)