The Assessment of Transcendental Meditation Training on ADD/ADHD Symptoms of Adolescents.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Cardiac vagal tone - indexed by heart rate variability (HRV)
研究概览
简要总结
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common developmental disorders experienced in childhood, with limited options for effective pharmacological treatment. Transcendental Meditation (TM) has been proposed to be used as a tool for attentional training and modulating autonomic nervous system activity in the ADHD population. However, the empirical support in favor of meditation for ADHD is limited, and the mechanism by which TM may have an effect on ADD/ADHD is not understood. There is also a conflicted data as to the nature of autonomic dysregulation of ADHD.
Heart Rate Variability (HRV) represents the beat to beat changes of heart rate in the interbeat interval, and considered to be a non-invasive tool to study autonomic nervous system. There is evidence that a non-directive meditation may increase parasympathetic activity and overall HRV. To the best of our knowledge, the differential effect of meditation on ADHD symptoms: according to the baseline HRV of the participants, or ADHD subtypes has not been assessed.
The aim of this study is to collect the data on ADHD adolescents who will get TM training as a part of out-of-school program, which is offered all children diagnosed with ADD/ADHD, aged 11.5 y-16y, in the community center of Kadima-Zoran, Israel.
The assessment of all of the children participating in this program will be performed with the help of validated questionnaires for diagnosis and follow-up of ADD/ADHD, and HRV monitoring.
In order to perform an assessment in a controlled way, the instruction of TM shall take place in two cycles of 3 months each.
详细描述
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common developmental disorders experienced in childhood, with a prevalence of 5 -10%, and can persist into adulthood (1) It is characterized by a combination of overactive, poorly modulated behavior with marked inattention and may involve physical aggression, which may be associated with a number of structural and functional abnormalities in the central nervous system (2).
Pharmacological treatment is often the treatment of choice; however its effectiveness is limited and often involves considerable side effects (3).
Meditation has been proposed to be used as a tool for attentional training and modulating autonomic nervous system activity in the ADHD population. A systematic review of meditation- based interventions for children with ADHD could not reach definite conclusions regarding their efficacy due to poor methodological quality of the studies (4).
A pilot randomized controlled study published few years ago demonstrated that three months of TM practice resulted in significant improvement of ADHD symptoms (5).
The mechanism by which TM may have an effect on ADD/ADHD is not understood. Furthermore, it is not clear whether TM may have a differential effect on the two subclasses of this condition: inattentive- and hyperactive- type
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with a confirmed diagnosis of ADHD
排除标准
- •Comorbidities of Conduct Disorder, ODD, OCD
- •Children on psychiatric medications
- •Other chronic diseases
结局指标
主要结局
Cardiac vagal tone - indexed by heart rate variability (HRV)
时间窗: The changes in HRV from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
HRV refers to changes in normal cardiac interbeat intervals, are under control of the vagus nerve (21), may be a biomarker of psychopathology (22) and of faster recovery from stress (23). HRV is also linked to social and emotional function and can be seen as an objective measure of emotional and social functioning both in healthy and ill population (24).
Achenbach Youth Self-Report (YSR) assesses overall behavioral and emotional functioning.
时间窗: The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
A self-reported scale that assesses overall behavioral and emotional functioning. appropriate behaviors, as well as inappropriate ones. The scale is designed for both parents and teachers, contains both social competency and behavior problem items.
次要结局
- Behavior Rating Inventory of Executive Function (BRIEF)(The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months)
- Conners 3 questionnaire(The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months)