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Exploring the Use of the CO-OP With Children With EF Functions Deficits Following ABI

Primary Purpose

Acquired Brain Injury

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CO-OP rehabilitation
Sponsored by
Hopitaux de Saint-Maurice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acquired Brain Injury focused on measuring Cognitive Orientation to daily Occupational Performance, Rehabilitation, Executive functions, child acquired brain injury, occupational performance

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria were:

  • 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

Exclusion criteria were:

  • 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

Sites / Locations

  • Saint Maurice Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CO-OP intervention

Arm Description

CO-OP intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.

Full Information

First Posted
January 12, 2021
Last Updated
January 17, 2021
Sponsor
Hopitaux de Saint-Maurice
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1. Study Identification

Unique Protocol Identification Number
NCT04718688
Brief Title
Exploring the Use of the CO-OP With Children With EF Functions Deficits Following ABI
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopitaux de Saint-Maurice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury
Keywords
Cognitive Orientation to daily Occupational Performance, Rehabilitation, Executive functions, child acquired brain injury, occupational performance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single case experimental study design (SCED) with multiple baselines across individuals and behaviors
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CO-OP intervention
Arm Type
Experimental
Arm Description
CO-OP intervention
Intervention Type
Other
Intervention Name(s)
CO-OP rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of Goal Attainment Scaling (GAS) change
Description
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.
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)
Secondary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
Before baseline, at immediate post-intervention, at 3-months post-intervention.
Title
Behavior Rating Inventory of Executive Function (BRIEF)
Description
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).
Time Frame
Three times during baseline, at immediate post-intervention, at 1- and 3-months post-intervention
Title
Children's cooking task
Description
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.
Time Frame
pre-intervention, immediate post-intervention and 3-months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria were: 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 Exclusion criteria were: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene LEBRAULT, Mec
Organizational Affiliation
Hopitaux de Saint-Maurice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Maurice Hospitals
City
Saint-Maurice
ZIP/Postal Code
94410
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33933689
Citation
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.
Results Reference
derived

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Exploring the Use of the CO-OP With Children With EF Functions Deficits Following ABI

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