Exploring the Use of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP) With Children, Teenagers and Young Adults With Executive Functions Deficits Following Severe Acquired Brain Injury

NCT04560777 | Completed DMC

• 1 other identifier: PHRIP-19-0074
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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. The hypothesis that CO-OP is effective in improving the occupational performance and executive functioning of these children on a daily basis is emerging, but needs to be confirmed. This study falls within this framework. Primary objective:

1. 1.To measure the distance maintenance of the knowledge acquired through rehabilitation, as well as the generalization and transfer into everyday life.
2. 2.Maintenance of acquired knowledge
3. 3.Generalization and transfer
4. 4.Impact of a consolidation session on generalization and transfer
5. 5.Gather the experience of family members/caregivers in accompanying their child in the CO-OP process outside of rehabilitation sessions.
6. 6.Establish the parental educational style and identify whether there is a link between the parental educational style and the commitment of the family members/caregivers.

Conditions

Acquired Brain Injury

Keywords

Cognitive Orientation to daily Occupational Performance; rehabilitation; executive functions; child acquired brain injury; teenagers; young adults; acquired brain injury

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 6-months post-intervention (Two times per week during baseline and intervention phase for each 4 chosen-goal ; one time at 2, 4 and 6-months post-intervention)

Secondary Outcomes (5)

• Canadian Occupational Performance Measure (COPM)

  Before baseline, at immediate post-intervention, at 2, 4 and 6-months post-intervention.

• Behavior Rating Inventory of Executive Function (BRIEF)

  Minimum 3-maximum 6 assessments during the baseline (according the duration of the baseline), week 2, 4 and 6 during the intervention, at immediate post-intervention, at 2, 4 and 6-months post-intervention.

• Évaluation des Pratiques Éducatives Parentales (EPEP, Parental Childrearing Behavior Scale for French-Speaking Parents, Children, and Adolescents)

  one time before baseline

• Questionnaire Engagement des Proches

  week 2, 4 and 6 during the intervention

• Entretien Engagement des Proches

  immediate post-intervention, 4 and 6 months-post-intervention

Study Arms (1)

experimental arm

EXPERIMENTAL

CO-OP intervention

Other: CO-OP intervention

Interventions

CO-OP intervention OTHER

The general structure of the intervention will follow the original key principles of CO-OP, with some adjustments to adapt it to the specificities of the ABI population (14 CO-OP sessions vs 10 in the original protocol). The global strategy will be taught to the participant at the first session. The following sessions will be consisted of an process of implementation of the global strategy in the context of guided discovery to identify domain specific strategies to overcome performance ''breakdowns" the participant will be experiencing when performing the self-selected tasks. In addition, "homework" will be assigned to encourage the application and practice of the cognitive strategies discovered during the intervention sessions. Parents will be invited to attend the sessions if it will be possible for them. In any case, the global strategy, as well as the progress of the child, will be explained to the parents.

experimental arm

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Child/adolescent/young adult aged between 8 and 21 years old, hospitalized in the Acquired Neurological Pathologies Service of the Saint-Maurice Hospitals or in the Medical and Pedagogical Centre for Adolescents of Neufmoutiers-en-Brie, and possibly schooled in this service.
• Diagnosis of acquired brain injury, for at least 6 months.
• Child/adolescent/young adult presenting executive function deficits as determined by the neuropsychological assessment (standardized tests and/or questionnaire).
• Vision and hearing normal or sufficient to communicate effectively (with appropriate correction if necessary).
• Having sufficient speaking and comprehension skills to communicate effectively and accurately.
• Enrollment in a Medicare plan or eligible beneficiary.
• Agreement of the child/young person and informed consent expressed by the holders of parental authority. Consent of the young adult (18-21 years of age).

You may not qualify if:

• Non-Francophone child/teenager/young adult and/or non-Francophone parents.
• With an intellectual disability (total IQ \<70), or severe impairment in comprehension, memory or attention, not compatible with understanding the goals of the rehabilitation and participation in 45-minute sessions.
• Neurological, psychiatric, genetic or learning disorder diagnosed prior to the occurrence of the acquired brain injury.
• Severe anxiety and/or depressive disorder diagnosed that is not compatible with participation in the study.
• Inability to commit until the end of the CO-OP rehabilitation phase (e.g., planned relocation, planned hospital discharge before the end of the 14 CO-OP sessions, i.e., 10 weeks including baseline and CO-OP rehabilitation).
• Major subject under guardianship or curatorship.

Sponsors & Collaborators

• Hopitaux de Saint-Maurice: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Hôpital Civil de Strasbourg: collaborator
• Ministry of Health, France: collaborator

Study Sites (2)

Centre Médical et Pédagogique pour Adolescents

Neufmoutiers-en-Brie, 77610, France

Location

Hôpitaux de Saint-Maurice

Saint-Maurice, 94410, France

Location

Related Publications (4)

• Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.

  PMID: 29253607 BACKGROUND

• Krasny-Pacini A, Hiebel J, Pauly F, Godon S, Chevignard M. Goal attainment scaling in rehabilitation: a literature-based update. Ann Phys Rehabil Med. 2013 Apr;56(3):212-30. doi: 10.1016/j.rehab.2013.02.002. Epub 2013 Feb 28.

  PMID: 23562111 BACKGROUND

• Scammell EM, Bates SV, Houldin A, Polatajko HJ. The Cognitive Orientation to daily Occupational Performance (CO-OP): A scoping review. Can J Occup Ther. 2016 Oct;83(4):216-225. doi: 10.1177/0008417416651277. Epub 2016 Jun 14.

  PMID: 27301479 BACKGROUND

• Manolov R, Lebrault H, Krasny-Pacini A. How to assess and take into account trend in single-case experimental design data. Neuropsychol Rehabil. 2024 Apr;34(3):388-429. doi: 10.1080/09602011.2023.2190129. Epub 2023 Mar 24.

  PMID: 36961228 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

• Mathilde CHEVIGNARD, PhD

  Hopitaux de Saint-Maurice

  STUDY DIRECTOR

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 with multiple baselines across individuals and behaviors. Randomization: 1. Which patient starts when the COOP sessions? 2. What are the possible starting points for the 3 goals to be worked on? 3. Which of the 4 goals ABCD is assigned to which goal number? The most important goal (A) will necessarily be worked on first. We will draw lots to determine the order in which the goals will be worked on and which goal will be designated as the control goal.

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 23, 2020
• Study Start: November 20, 2020
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

FR (2)