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临床试验/NCT01841151
NCT01841151已完成不适用

Does Neurofeedback and Working Memory Training Improve Core Symptoms of ADHD in Children and Adolescents? A Comparative, Randomized and Controlled Study.

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
202
试验地点
1
主要终点
Conners 3 ADHD-index

研究概览

简要总结

The purpose of this study is to investigate if neurofeedback and working memory training improves core symptoms of ADHD in children and adolescents.

详细描述

This study investigates two types of Neurofeedback (NF), one well-established and well-researched protocol called Slow Cortical Potential NF (SCP), and a newer and less researched, yet popular among private clinicians, the so-called live z-score training (LZT). These methods are compared to working memory training (WMT) and a passive control condition, treatment-as-usual only (TAU). The active conditions (SCP/LZT/WMT) are delivered high frequent, with 5 sessions/week, for a total of 25 sessions.

Outcomes measures are taken at Preintervention and Postintervention, as well as at a 6-month follow-up assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
9 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical AD/HD diagnose according to DSM-IV-TR and K-SADS interview, 9-17 years old, unmedicated or under stable medication with stimulants or corresponding since at least one month.

排除标准

  • IQ <70 (WISC-IV or WAIS-IV), clinically instable psychiatric state e.g. severe depression, OCD, self-injurious behaviour, bipolar disorder, severe somatic (neurologic) disease, very limited knowledge in the Swedish language.

研究组 & 干预措施

SCP training

Active Comparator

Neurofeedback 1 (NF1) Slow Cortical Potential (SCP) training

干预措施: SCP training (Behavioral)

Live Z-score training

Active Comparator

Neurofeedback 2 (NF2) Live Z-score training

干预措施: Live Z-score training (Behavioral)

WM training

Active Comparator

Working Memory training (WMt)

干预措施: WM training (Behavioral)

Waiting-list

No Intervention

Treatment as usual only

结局指标

主要结局

Conners 3 ADHD-index

时间窗: Up to seven months

Presented below are the within-group differences from baseline to 6-month follow up, for the ADHD-index of the Conners-3. Positive numbers indicate symptom improvements. \*The ADHD-index raw score can range from 0-20, with higher score indicating greater symptom severity. The Reliable Change Index (RCI) is 2.88.

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

Sven Bölte

Professor, PhD, head of pediatric neuropsychiatry unit

Karolinska Institutet

研究点 (1)

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