Acquired Brain InjuryNCT04718688
Exploring the Use of the CO-OP With Children With EF Functions Deficits Following ABI
A study testing CO-OP rehabilitation in people with Acquired Brain Injury, run by Hopitaux de Saint-Maurice at 1 site in France.
Trial summary
Purpose: Acquired brain injury (ABI) in childhood are the cause of disabling motor, cognitive and behavioural disorders, with severe consequences on the later development of autonomy and learning, with long-term repercussions on independence for activities of daily living, and social and professional integration. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- CO-OP rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8 to 14 years
- Diagnosis of ABI, sustained at least 6 months previously, still attending an in- or outpatient rehabilitation program following injury
- Evidence of a dysexecutive syndrome on the neuropsychological assessment
- Normal vision and hearing (with appropriate correction if necessary)
- Sufficient language skills to understand and to communicate explicitly
Who cannot join
- Non-French-speaking child or parents
- Sensory-motor or visual impairments precluding participation in the study
- Intellectual deficit (Full-Scale Intellectual Quotient (IQ)<70), or severe impairments in comprehension, memory or attention, incompatible with understanding and choosing rehabilitation goals and participating in 45-minutes sessions
- Neurological, psychiatric, genetic or learning disability diagnosed prior to the ABI
- Severe anxiety or depression symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Use of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP) With Children With Executive Functions Deficits Following Severe Acquired Brain Injury: a Single Case Experimental Design Study
Purpose:
Acquired brain injury (ABI) in childhood are the cause of disabling motor, cognitive and behavioural disorders, with severe consequences on the later development of autonomy and learning, with long-term repercussions on independence for activities of daily living, and social and professional integration. Among cognitive disorders, executive function (EF) deficits are among the most frequent and disabling, with major consequences on the development of autonomy and the course of schooling and learning. The Cognitive Orientation to daily Occupational Performance (CO-OP) could be an interesting approach for the rehabilitation of these consequences. CO-OP 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. It has been shown to be effective in a variety of populations, but has been little explored in children with ABI.
Objectives To assess whether the use of CO-OP could be of interest in children with executive functions deficits following ABI, to improve their occupational performance, their executive functioning in everyday life and their cognitive processes constituting EF.
Read the detailed description
Method
- Single case experimental study with multiple baselines across individuals and behaviors
- 14 individual sessions of CO-OP intervention.
- Two goals trained, one control goal.
- Different assessments used : Canadian Occupational Performance Measure (COPM), the Goal Attainment Scales (GAS), the Children's Cooking Task (CCT) and parent- and teacher-ratings of the Behavior Rating Inventory of Executive Functions (BRIEF) questionnaire.
- Conditions
- Acquired Brain Injury
- Being tested
- CO-OP rehabilitation
- Keywords
- Cognitive Orientation to daily Occupational Performance, Rehabilitation, Executive functions, child acquired brain injury, occupational performance
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO-OP rehabilitationOther
The intervention was included within the child's conventional rehabilitation program.
In the CO-OP original protocol, the child sets 3 goals. Here, we concentrated on two rather than three goals, as addressing three occupations per session seemed too ambitious given the children's cognitive profile (the third goal served as control goal).
We chose to increase the number of sessions to 14 (two sessions per week for seven weeks, vs ten in the original protocol).
The global strategy was taught to the child at the first session. The following sessions consisted of an iterative process of implementation of the global strategy in the context of guided discovery to identify domain specific strategies to overcome performance ''breakdowns" the children were experiencing when performing the self-selected tasks. In addition, "homework" was assigned to encourage the application and practice. Parents were invited to attend the sessions if it was possible for them.
| Study group | Role | What they receive |
|---|---|---|
| CO-OP intervention | Experimental | CO-OP intervention Receives: Other: CO-OP rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Goal Attainment Scaling (GAS) change
Goal Attainment Scaling (GAS) is a method for writing personalized evaluation scales in order to quantify progress toward defined goals.
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;
- Defining five goal attainment levels (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 is used: ''-2'' is the initial pretreatment (baseline) 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, and ''+2'' is the best possible outcome that could have been expected for this goal.
Measured: Baseline to 3-months post-intervention (Three times per week during baseline and intervention phase for each 3 chosen-goal ; one time at 3-months post-intervention)
Secondary outcomes (3)
Canadian Occupational Performance Measure (COPM)
This semi-structured interview helps children/parents identify problematic occupations in different daily areas. COPM will be used: (1) To determine (only with the child) the 4 problematic occupations identified as the most important (3 will be used as target goals, while the 4 will serve as a control goal); (2) To determine changes in occupational performance in self-selected goals: children and parents will rated their performance and satisfaction associated with these 4 occupations. 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.
Measured: Before baseline, at immediate post-intervention, at 3-months post-intervention.
Behavior Rating Inventory of Executive Function (BRIEF)
The parent and teacher report forms of the Behavior Rating Inventory of Executive Function (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: Three times during baseline, at immediate post-intervention, at 1- and 3-months post-intervention
Children's cooking task
The Children's Cooking Task (CCT) is an ecological standardized task designed to assess EF during actual execution of a complex task: the child is asked to prepare a chocolate cake and a fruit cocktail following two simple, highly structured, illustrated recipes with numbered steps. The CCT was used as a secondary outcome measure in this study in order to determine whether children transferred progress in problem-solving, acquired through strategies discovered with CO-OP, onto the performance of a complex task, unrelated to the trained goals.
Measured: pre-intervention, immediate post-intervention and 3-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 posted22 Jan 2021
- Study start1 Jan 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies 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
- single case experimental study design (SCED) with multiple baselines across individuals and behaviors
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopitaux de Saint-Maurice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene LEBRAULT, Mec, Principal investigator, Hopitaux de Saint-Maurice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718688
- Sponsor's protocol ID
- M2 COOP_HL
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lebrault H, Chavanne C, Abada G, Latinovic B, Varillon S, Bertrand AF, Oudjedi E, Krasny-Pacini A, Chevignard M. Exploring the use of the Cognitive Orientation to daily Occupational Performance approach (CO-OP) with children with executive functions deficits after severe acquired brain injury: A single case experimental design study. Ann Phys Rehabil Med. 2021 Sep;64(5):101535. doi: 10.1016/j.rehab.2021.101535. Epub 2021 Jul 17.
PubMed 33933689
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Use of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP) With Children With Executive Functions Deficits Following Severe Acquired Brain Injury: a Single Case Experimental Design Study
- ClinicalTrials.gov ID
- NCT04718688
- Acronym / sponsor ID
- M2 COOP_HL
- Conditions
- Acquired Brain Injury
- Keywords
- Cognitive Orientation to daily Occupational Performance, Rehabilitation, Executive functions, child acquired brain injury, occupational performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hopitaux de Saint-MauriceUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 22 Jan 2021 (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.
Purpose:
Acquired brain injury (ABI) in childhood are the cause of disabling motor, cognitive and behavioural disorders, with severe consequences on the later development of autonomy and learning, with long-term repercussions on independence for activities of daily living, and social and professional integration. Among cognitive disorders, executive function (EF) deficits are among the most frequent and disabling, with major consequences on the development of autonomy and the course of schooling and learning. The Cognitive Orientation to daily Occupational Performance (CO-OP) could be an interesting approach for the rehabilitation of these consequences. CO-OP 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. It has been shown to be effective in a variety of populations, but has been little explored in children with ABI.
Objectives To assess whether the use of CO-OP could be of interest in children with executive functions deficits following ABI, to improve their occupational performance, their executive functioning in everyday life and their cognitive processes constituting EF.
Detailed description
Method
- Single case experimental study with multiple baselines across individuals and behaviors
- 14 individual sessions of CO-OP intervention.
- Two goals trained, one control goal.
- Different assessments used : Canadian Occupational Performance Measure (COPM), the Goal Attainment Scales (GAS), the Children's Cooking Task (CCT) and parent- and teacher-ratings of the Behavior Rating Inventory of Executive Functions (BRIEF) questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single case experimental study design (SCED) with multiple baselines across individuals and behaviors
| Arm | Type | Receives |
|---|---|---|
| CO-OP intervention | Experimental | Other: CO-OP rehabilitationCO-OP intervention |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 8 to 14 years
- Diagnosis of ABI, sustained at least 6 months previously, still attending an in- or outpatient rehabilitation program following injury
- Evidence of a dysexecutive syndrome on the neuropsychological assessment
- Normal vision and hearing (with appropriate correction if necessary)
- Sufficient language skills to understand and to communicate explicitly
Key exclusion criteria (5 listed)
- Non-French-speaking child or parents
- Sensory-motor or visual impairments precluding participation in the study
- Intellectual deficit (Full-Scale Intellectual Quotient (IQ)<70), or severe impairments in comprehension, memory or attention, incompatible with understanding and choosing rehabilitation goals and participating in 45-minutes sessions
- Neurological, psychiatric, genetic or learning disability diagnosed prior to the ABI
- Severe anxiety or depression symptoms
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 |
|---|---|---|
| CO-OP rehabilitationThe intervention was included within the child's conventional rehabilitation program. In the CO-OP original protocol, the child sets 3 goals. Here, we concentrated on two rather than three goals, as addressing three occupations per session seemed too ambitious given the children's cognitive profile (the third goal served as control goal). We chose to increase the number of sessions to 14 (two sessions per week for seven weeks, vs ten in the original protocol). The global strategy was taught to the child at the first session. The following sessions consisted of an iterative process of implementation of the global strategy in the context of guided discovery to identify domain specific strategies to overcome performance ''breakdowns" the children were experiencing when performing the self-selected tasks. In addition, "homework" was assigned to encourage the application and practice. Parents were invited to attend the sessions if it was possible for them. | Other | CO-OP intervention |
Primary outcome
Assessment of Goal Attainment Scaling (GAS) change
Time frame: Baseline to 3-months post-intervention (Three times per week during baseline and intervention phase for each 3 chosen-goal ; one time at 3-months post-intervention)
Goal Attainment Scaling (GAS) is a method for writing personalized evaluation scales in order to quantify progress toward defined goals. 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; * Defining five goal attainment levels (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 is used: ''-2'' is the initial pretreatment (baseline) 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, and ''+2'' is the best possible outcome that could have been expected for this goal.
3 secondary outcomes
Canadian Occupational Performance Measure (COPM)
Time frame: Before baseline, at immediate post-intervention, at 3-months post-intervention.
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: Three times during baseline, at immediate post-intervention, at 1- and 3-months post-intervention
Children's cooking task
Time frame: pre-intervention, immediate post-intervention and 3-months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Derived from this study: PubMed 33933689Lebrault H, Chavanne C, Abada G, Latinovic B, Varillon S, Bertrand AF, Oudjedi E, Krasny-Pacini A, Chevignard M. Exploring the use of the Cognitive Orientation to daily Occupational Performance approach (CO-OP) with children with executive functions deficits after severe acquired brain injury: A single case experimental design study. Ann Phys Rehabil Med. 2021 Sep;64(5):101535. doi: 10.1016/j.rehab.2021.101535. Epub 2021 Jul 17.
- Individual participant dataSharing planned: No
Related trials for Acquired Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
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. This study is not recruiting at the moment.
Helene LEBRAULT, Mec principal investigator
Hopitaux de Saint-Maurice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO-OP rehabilitation in people with Acquired Brain Injury, 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 22 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Goal Attainment Scaling (GAS) change (time frame: Baseline to 3-months post-intervention (Three times per week during baseline and intervention phase for each 3 chosen-goal ; one time at 3-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 NCT04718688, which also lists 1 linked publication.
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 22 Jan 2021.