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

NCT04718688 | Completed

• 1 other identifier: M2 COOP_HL
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury

Keywords

Cognitive Orientation to daily Occupational Performance; Rehabilitation; Executive functions; child acquired brain injury; occupational performance

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Before baseline, at immediate post-intervention, at 3-months post-intervention.

• Behavior Rating Inventory of Executive Function (BRIEF)

  Three times during baseline, at immediate post-intervention, at 1- and 3-months post-intervention

• Children's cooking task

  pre-intervention, immediate post-intervention and 3-months post-intervention

Study Arms (1)

CO-OP intervention

EXPERIMENTAL

CO-OP intervention

Other: CO-OP rehabilitation

Interventions

CO-OP rehabilitation OTHER

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.

CO-OP intervention

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopitaux de Saint-Maurice: lead

Study Sites (1)

Saint Maurice Hospitals

Saint-Maurice, 94410, France

Location

Related Publications (1)

• 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.

  PMID: 33933689 DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Helene LEBRAULT, Mec

  Hopitaux de Saint-Maurice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single case experimental study design (SCED) with multiple baselines across individuals and behaviors

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 22, 2021
• Study Start: January 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)