Let's CO-OPerate! Together we Are Stronger: Exploring the Effectiveness of the CO-OP Cognitive Problem-solving Approach in the Context of an Intensive Group Rehabilitation Training for a Paediatric Population With Executive Function Deficits and/or Developmental Coordination Disorders Following Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Goal Attainment Scale (GAS)
研究概览
简要总结
The goal of this replicated single case experimental study using a randomized multiple baseline design across participants and goals is to enable children/adolescents (aged 8-16 years) with developmental coordination disorders and/or executive function deficits following an acquired or congenital brain injury, to achieve their occupational goals. The aim is to make them more independents and autonomous in their daily lives. To achieve this, we're going to offer them an intensive group CO-OP (Cognitive Orientation to daily Occupational Performance Approach) rehabilitation training, and actively involving the parents. The main questions it aims to answer are:
- To evaluate the improvement in occupational performance* (and its maintenance over time) following intervention using the CO-OP Approach.
*Occupational performance is a person's ability to choose, organize and engage in meaningful occupations that give them satisfaction. These occupations, determined by culture and corresponding to their age group, enable them to take care of themselves, have fun and contribute to the social and economic fabric of the community.
- To gather parents' experiences of supporting their child during the CO-OP intervention and its follow-up phase.
Participants will be asked to identify 3 goals that they would like to achieve with the CO-OP Approach. The CO-OP intervention will take the form of two half-days a week for 5 weeks, with 1 hour 30 minutes of individual CO-OP sessions and 1 hour 30 minutes of group sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children/adolescents (8-16 years old) with coordination disorders and/or executive function deficits, following a acquired brain injury more than 3 months ago or a congenital brain lesion or a neurodevelopmental disorder.
- •Executive function deficits as assessed by neuropsychological tests (standardised tests and/or questionnaires) and/or coordination disorders as assessed by neuropsychological tests (standardised tests and/or questionnaires).
- •Vision and hearing normal or sufficient to communicate effectively (with appropriate correction where necessary).
- •Cognitive, behavioural and expressive/receptive communication skills enabling them to identify goals and participate actively in the CO-OP intervention process.
- •Membership of a health insurance scheme or beneficiary.
- •Agreement of the child/adolescent and informed consent expressed by at least one of the holders of parental authority.
- •Non-inclusion criteria :
- •Children/adolescents who do not meet the inclusion criteria.
- •Children/adolescents and/or parents non-French-speaking.
- •Presenting intellectual difficulties, or severe problems of comprehension, memory or attention, as described in the CO-OP recommendations.
- •A diagnosed severe anxiety-depressive disorder that is not compatible with participation in the study.
- •Inability to remain involved until the end of the CO-OP intervention phase (e.g. planned move).
排除标准
- 未提供
结局指标
主要结局
Goal Attainment Scale (GAS)
时间窗: Baseline to 6-months post-intervention: two times per week during baseline and intervention phase for each chosen-goal ; one time at 2, 4 and 6-months post-intervention.
The Goal Attainment Scale (GAS) is a criterion--referenced measure used to quantify the degree to which personal goals are achieved. 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; * 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 will be used: "-2" is the initial pretreatment 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; ''+2'' is the best possible outcome that could have been expected for this goal.
次要结局
- Canadian Occupational Performance Measure (COPM)(Once before baseline, at immediate post-intervention, at 2, 4 and 6-months post-intervention.)
- Behavior Rating Inventory of Executive Function questionnaire (BRIEF)(twice in baseline, once in immediate post-intervention and once at 2,4,6 month post-intervention.)
- Entretien Engagement des Proches(once at immediate post-intervention, 4 and 6 months-post-intervention])
研究者
Hélène LEBRAULT
principal investigator
Hopitaux de Saint-Maurice