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临床试验/NCT04718688
NCT04718688已完成不适用

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

Hopitaux de Saint-Maurice2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2
试验地点
2
主要终点
Assessment of Goal Attainment Scaling (GAS) change

研究概览

简要总结

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.

详细描述

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.

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 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Assessment of Goal Attainment Scaling (GAS) change

时间窗: 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)

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.

次要结局

  • Children's cooking task(pre-intervention, immediate post-intervention and 3-months post-intervention)
  • 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)

研究者

发起方
Hopitaux de Saint-Maurice
申办方类型
Other
责任方
Sponsor

研究点 (2)

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