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

NCT ID: NCT04718688

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-06-30

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.

Conditions

Acquired Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CO-OP intervention

CO-OP intervention

Group Type: EXPERIMENTAL

CO-OP rehabilitation

Intervention Type: 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.

Interventions

CO-OP rehabilitation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopitaux de Saint-Maurice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helene LEBRAULT, Mec

Role: PRINCIPAL_INVESTIGATOR

Hopitaux de Saint-Maurice

Locations

Saint Maurice Hospitals

Saint-Maurice, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 33933689 (View on PubMed)

Other Identifiers

M2 COOP_HL

Identifier Type: -

Identifier Source: org_study_id