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一项针对儿童注意力缺陷多动障碍(ADHD)的神经情感技术(NET)随机对照试验:方案

A randomised controlled trial of the Neuro Emotional Technique (NET) for childhood Attention Deficit Hyperactivity Disorder (ADHD): a protocol.

作者信息

Karpouzis Fay, Pollard Henry, Bonello Rod

机构信息

Department of Health and Chiropractic, Macquarie University, Sydney, 2109, Australia.

出版信息

Trials. 2009 Jan 27;10:6. doi: 10.1186/1745-6215-10-6.

Abstract

BACKGROUND

An abundance of literature is dedicated to research for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Most, is in the area of pharmacological therapies with less emphasis in psychotherapy and psychosocial interventions and even less in the area of complementary and alternative medicine (CAM).The use of CAM has increased over the years, especially for developmental and behavioral disorders, such as ADHD. 60-65% of parents with children with ADHD have used CAM. Medical evidence supports a multidisciplinary approach (i.e. pharmacological and psychosocial) for the best clinical outcomes. The Neuro Emotional Technique (NET), a branch of Chiropractic, was designed to address the biopsychosocial aspects of acute and chronic conditions including non-musculoskeletal conditions. Anecdotally, it has been suggested that ADHD may be managed effectively by NET.

DESIGN/METHODS: A placebo controlled, double blind randomised clinical trial was designed to assess the effectiveness of NET on a cohort of children with medically diagnosed ADHD. Children aged 5-12 years who met the inclusion criteria were randomised to one of three groups. The control group continued on their existing medical regimen and the intervention and placebo groups had the addition of the NET and sham NET protocols added to their regimen respectively. These two groups attended a clinical facility twice a week for the first month and then once a month for six months. The Conners' Parent and Teacher Rating Scales (CRS) were used at the start of the study to establish baseline data and then in one month and in seven months time, at the conclusion of the study. The primary outcome measures chosen were the Conners' ADHD Index and Conners' Global Index. The secondary outcome measures chosen were the DSM-IV: Inattentive, the DSM-IV:Hyperactive-Impulsive, and the DSM-IV:Total subscales from the Conners' Rating Scales, monitoring changes in inattention, hyperactivity and impulsivity. Calculations for the sample size were set with a significance level of 0.05 and the power of 80%, yielding a sample size of 93.

DISCUSSION

The present study should provide information as to whether the addition of NET to an existing medical regimen can improve outcomes for children with ADHD.

TRIAL REGISTRATION

Australian New Zealand Clinical Trial Registration Number: ANZCTRN 012606000332527.

摘要

背景

大量文献致力于注意力缺陷多动障碍(ADHD)治疗的研究。大多数研究集中在药物治疗领域,对心理治疗和社会心理干预的关注较少,而在补充与替代医学(CAM)领域的关注更少。近年来,CAM的使用有所增加,尤其是用于治疗发育和行为障碍,如ADHD。60%-65%患有ADHD儿童的家长使用过CAM。医学证据支持采用多学科方法(即药物治疗和社会心理治疗)以获得最佳临床效果。神经情感技术(NET)是整脊疗法的一个分支,旨在解决急性和慢性疾病(包括非肌肉骨骼疾病)的生物心理社会问题。坊间有观点认为,NET可能有效治疗ADHD。

设计/方法:设计了一项安慰剂对照、双盲随机临床试验,以评估NET对一组经医学诊断患有ADHD儿童的有效性。符合纳入标准的5至12岁儿童被随机分为三组。对照组继续其现有的医疗方案,干预组和安慰剂组则分别在其方案中增加NET和假NET方案。这两组在第一个月每周到临床机构就诊两次,然后在接下来的六个月每月就诊一次。在研究开始时使用康纳斯父母与教师评定量表(CRS)建立基线数据,然后在研究结束时的一个月和七个月时再次使用。选择的主要结局指标是康纳斯ADHD指数和康纳斯总体指数。选择的次要结局指标是《精神疾病诊断与统计手册》第四版(DSM-IV):注意力不集中、DSM-IV:多动-冲动以及康纳斯评定量表中的DSM-IV:总分量表,监测注意力不集中、多动和冲动方面的变化。样本量计算设定的显著性水平为0.05,检验效能为80%,得出样本量为93。

讨论

本研究应能提供关于在现有医疗方案中添加NET是否能改善ADHD儿童治疗效果的信息。

试验注册

澳大利亚和新西兰临床试验注册号:ANZCTRN 012606000332527。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df41/2646715/5342a79fb4f5/1745-6215-10-6-1.jpg

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