Executive Function Deficits (EFD)NCT07085403
Let's CO-OPerate! Together we Are Stronger
A study testing Cognitive Orientation to daily Occupational Performance (CO-OP) is a cognitive problem-solving approach in people with Executive Function Deficits (EFD) and Developmental Coordination Disorder, run by Hopitaux de Saint-Maurice at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Executive Function Deficits (EFD), Developmental Coordination Disorder, Acquired Brain Injury (Including Stroke)
- What is being tested?
- Cognitive Orientation to daily Occupational Performance (CO-OP) is a cognitive problem-solving approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Show all 12Show fewer
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpitaux Paris-Est Val-de-Marne
Saint-Maurice, Île-de-France Region, 94410
Helene LEBRAULT, OT, PhD, +0033607659198, helene.lebrault@ght94n.fr
About this study
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
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
- Being tested
- Cognitive Orientation to daily Occupational Performance (CO-OP) is a cognitive problem-solving approach
- 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
- Medical subject headings
- Motor Skills Disorders, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Orientation to daily Occupational Performance (CO-OP) is a cognitive problem-solving approachOther
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.
| Study group | Role | What they receive |
|---|---|---|
| COOP experimental arm | Experimental | Not described Receives: Other: Cognitive Orientation to daily Occupational Performance (CO-OP) is a cognitive problem-solving approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Once before baseline, at immediate post-intervention, at 2, 4 and 6-months post-intervention.
Behavior Rating Inventory of Executive Function questionnaire (BRIEF)
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).
Measured: twice in baseline, once in immediate post-intervention and once at 2,4,6 month post-intervention.
Entretien Engagement des Proches
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.
Measured: once at immediate post-intervention, 4 and 6 months-post-intervention]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Executive Function Deficits (EFD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- replicated single case experimental study using a randomized multiple baseline design across participants and goals
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopitaux de Saint-Maurice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hélène LEBRAULT, Hopitaux de Saint-Maurice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085403
- Sponsor's protocol ID
- COOPerons - PR- 2024 - 7
- Status last verified
- Aug 2025
- First submitted
- 4 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19154553Polatajko 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.
PubMed 11345506
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07085403
- Acronym / sponsor ID
- COOPerons - PR- 2024 - 7
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hopitaux de Saint-MauriceUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- replicated single case experimental study using a randomized multiple baseline design across participants and goals
| Arm | Type | Receives |
|---|---|---|
| COOP experimental arm | Experimental | Other: Cognitive Orientation to daily Occupational Performance (CO-OP) is a cognitive problem-solving approach |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Orientation to daily Occupational Performance (CO-OP) is a cognitive problem-solving approachCognitive 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. | Other | COOP experimental arm |
Primary outcome
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.
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.
3 secondary outcomes
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]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Background: PubMed 19154553Steenbeek 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.
- Background: PubMed 11345506Polatajko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Orientation to daily Occupational Performance (CO-OP) is a cognitive problem-solving approach in people with Executive Function Deficits (EFD) and Developmental Coordination Disorder, run by Hopitaux de Saint-Maurice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helene LEBRAULT, OT, PhD (+0033143966682, helene.lebrault@ght94n.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07085403, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.