跳至主要内容
临床试验/NCT05125120
NCT05125120Unknown不适用

THE EFFECT OF THE COGNITIVE ORIENTATION TO DAILY OCCUPATIONAL PERFORMANCE (CO-OP) APPROACH IN CHILDREN WITH ATTENTION DEFICIT AND HYPERACTIVITY DISORDER ON MOTOR PERFORMANCE AND EXECUTIVE FUNCTIONS: A RANDOMIZED CONTROLLED STUDY

Hacettepe University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
The Canadian Occupational Performance Measure (COPM)

研究概览

简要总结

Attention deficit and hyperactivity disorder (ADHD) is a behavioural and neurodevelopmental disorder that can affect behavioural, emotional, academic, social, and cognitive functions and is not age-appropriate. The prevalence of ADHD among school children is reported to be 3%-11%. Children with ADHD have difficulties paying attention to details, concentrating, completing tasks and following instructions, among other social and academic challenges. In children with ADHD, insufficient activity in the prefrontal regions of the brain has been evidenced, which is linked to executive function skills. Such children have difficulties in performing executive functions that require a high level of cognitive skills, such as self-control and regulation, as well as sequencing and planning tasks. The Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) addresses executive dysfunction as a characteristic of ADHD. At the same time, 45%-70% of these children show problems in motor skills. Motor problems associated with ADHD, such as manual dexterity, bilateral coordination, and postural balance, can lead to difficulty in everyday living tasks, such as eating and writing, as well as social adaptability, academic skills, and peer interactions. For this reason, motor skill problems along with symptoms of inattention, hyperactivity, and impulsivity, should be addressed as part of the treatment strategy. ADHD has an impact on a child's independence for daily activities. As a result, child-specific occupational therapy approaches are critical for the sensory, motor, and cognitive areas that affect children's occupational performance in basic and instrumental activities of daily living, participation, rest and sleep, play, and leisure.

详细描述

Afyonkarahisar University of Health Sciences Non-Invasive Clinical Research Ethics Committee evaluated the study with the 2011-KAEK-2 ethics committee code. The study was planned to be carried out in Afyonkarahisar State Hospital Occupational Therapy Unit. It was planned to include 30 children between the ages of 7 and 12 who were diagnosed with ADHD according to the DSM-5 criteria by a child psychiatrist. Children will be randomly divided into two groups: 15 in the intervention group and 15 in the control group. At the beginning of the study, the purpose of the study will be explained to the family and the child and informed consent forms will be signed. Standard tests will be applied after the sociodemographic information of the child and his family is obtained. With the CO-OP approach, the intervention group will receive two sessions of therapy per week, each for approximately one hour, for a total of 6 weeks and 12 sessions. After 6 weeks, standard assessments will be repeated. The control group will receive the same standardized assessments at baseline and 6 weeks later with no further intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Having a mental, chronic neurological or orthopedic disorder in addition to ADHD

结局指标

主要结局

The Canadian Occupational Performance Measure (COPM)

时间窗: five weeks

It is an client-centred semi-structured interview method in which individuals score their performance and satisfaction in the activities that they need, want, or are required to accomplish in the areas of self-care, productivity, and leisure (17, 18). On a 10-point scale (1=not able to do=not satisfied at all, 10=can be done=pleased), the individual ranks the activities that he or she considers significant for themselves separately in terms of performance and satisfaction

Goal Attainment Scaling (GAS)

时间窗: five weeks

It is used to determine whether children have met their functional activity goals. It's critical that the objectives are clear, measurable, and well-timed (21, 22). The various achievable results for each aim are defined independently at five levels while scoring the GAS: -2, -1, 0, +1, and +2. The initial level is -2, and the child's level is re-evaluated after the application

The Bruininks-Oseretsky Test of Motor Proficiency and Performance-Short Form (BOTMP-SF)

时间窗: five weeks

The BOTMP-SF which was modified from the long version and is used to assess children's motor abilities, has 14 items and a maximum score of 98. BOTMP-SF assesses upper extremity coordination, balance, visual-motor control, and other skills in three areas: gross motor, gross-fine motor, and fine motor

The Executive Functions and Occupational Routines Scale (EFORTS)

时间窗: five weeks

This scale is used to assess executive function skills and activity routines of children aged 6-12 years, including impulsivity, verbal and nonverbal memory, self-regulation, planning, and problem-solving. It is divided into three sections: morning-evening routine, game-entertainment routines, and social routines

Visual Analogue Scale (VAS)

时间窗: five weeks

The VAS is a scale for converting some values that are difficult to measure numerically into numerical data. The participant uses a vertical line on a 0-10 cm scale to denote his or her emotional state, and the distance is measured with a ruler. The VAS was used to measure the level of satisfaction of families with therapy in this study.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

SEDANUR GÜRLEK

SEDANUR GÜRLEK (Master's degree)(Occupational Therapist)

Hacettepe University

研究点 (1)

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