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临床试验/NCT02572180
NCT02572180Unknown不适用

A Biofeedback Training in Schoolchildren With an Attention-Deficit/Hyperactivity Disorder (ADHD): Differential Effects of Training in a 2D or 3D Environment

University Hospital Tuebingen1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
ADHD symptomatology

研究概览

简要总结

This study aims towards investigating the efficacy of a near-infrared spectroscopy (NIRS)-based neurofeedback training in a virtual reality (VR) classroom in schoolchildren with attention-deficit/hyperactivity disorder (ADHD). The investigators are especially interested in the training's impact on academic performance, executive functioning (EF) and behavioral ADHD symptoms. Furthermore, the investigators aim at examining the influence of teachers' instructional behavior on children with ADHD's learning in a short virtual reality classroom scenario. Several studies provide evidence that poor academic achievement in ADHD is mainly due to impairments in EF and ADHD behavior (e.g., Frazier, Youngstrom, Glutting, & Watkins, 2007; Miller et al., 2013). Furthermore, studies show that these factors are related to neurophysiological characteristics found in electroencephalographic (EEG) or functional NIRS (fNIRS) examinations (e.g., Barry, Clarke, & Johnstone, 2003; Barry, Johnstone, & Clarke, 2003; Loo & Barkley, 2005; Negoro et al., 2010). Neurofeedback trainings aim at improving these neurophysiological as well as cognitive-behavioral deficits (Gevensleben, Moll, Rothenberger, & Heinrich, 2014), and are expected to improve academic performance in children with ADHD accordingly. Training in a VR classroom, from the investigators' perspective, facilitates generalization of self-regulation competences to real-life academic situations and at the same time increases the effort invested into the training compared to a training in 2D settings. Consequently, training in a VR classroom is hypothesized to lead to greater improvement in academic performance, EF and a greater decrease of ADHD symptoms than a training in a 2D setting. Moreover, the investigators hypothesize that these effects are more pronounced in children who receive a NIRS-based neurofeedback training compared to children receiving a biofeedback training based on an electromyogram (EMG).

详细描述

  1. Strategies 90 schoolchildren from Grade 1 to 4 that meet criteria for a DSM-V diagnosis of ADHD (any presentation) will be recruited. The design will involve three groups (n = 30 per group; N = 90) to which recruited children will be assigned randomly, but matched for age, gender, and medication. In addition to VR NIRS NF and VR EMG biofeedback groups, a third group will experience the NIRS NF in the exact same 2D classroom environment.
  2. The Study 2.1. Testing Protocol Informed consent discussion: Parents of children pre-diagnosed with ADHD will not undergo a screening process. However, parents whose children have not been pre-diagnosed with ADHD before, will be provided with the German version of the Conners-3 parent ADHD-Index (C3-AI). Only if the screening indicates that the child is at an increased risk of having ADHD, will the investigators proceed with an informed consent discussion. If the screening indicates that it is unlikely that the child has ADHD, the investigators will exclude the child from the study. After the meeting, if the child was either pre-diagnosed with ADHD before, or the screening indicates an increased likelihood for the child to have ADHD, parents will have enough time to think about whether they want to give written informed consent to participate in the study.

If parents give written informed consent, the next step will be a session in which the ADHD diagnosis is verified. For this session, parents will be informed about three opportunities.

  1. Diagnostic session in the scope of their participation in a second study at the pediatric clinic in Tübingen at the same time that they participate in our biofeedback study. This study is called "Aufmerksamkeit und Kognition bei Kindern mit Neurofibromatose Typ 1", which is still searching for children with ADHD only (without neurofibromatosis type 1) to form a control group.
  2. Diagnostic session in the scope of the "Spezialsprechstunde ADHS" in the outpatient clinic of the department of child and adolescence psychiatry.
  3. Diagnostic session within the scope of this biofeedback study as described below.

Diagnostic session: For a standardized confirmation as well as a characterization of the diagnosis, the long versions of the Conners-3 parent and teacher rating scales (3-P and 3-T) will be applied. Furthermore, the German version of the Strengths- and Difficulties Questionnaire (SDQ-Deu) is going to assess the severity of the symptoms as well as comorbidities from class teacher as well as parental perspective. In order to assess the actual quality of life of parents and child parents and children will be asked to fill out the Kiddy-Kindl in its appropriate version. Moreover, surrounding variables such as medication, prior treatment, other clinical diagnoses etc. will be assessed with a questionnaire. As neuropsychological variables, intelligence will be assessed using the short version of the Culture Fair Test (CFT 1-R or CFT 20-R).

Pre-Test:

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
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Going to school Grade 1-
  • •Clinical diagnosis of ADHD combined, predominantly inattentive or predominantly hyperactive-impulsive type according to DSM-V.
  • •IQ > 70 as assessed with the CFT 1-R or CFT 20-R (Weiß & Osterland, 2013; Weiß & Weiß, 2006).
  • •No additional serious physical, neurological or mental disorder as specified below.

排除标准

  • •Not going to school or in other Grades than 1-
  • •No clinical diagnosis of ADHD according to the DSM-V.
  • •IQ < 70 as assessed with the CFT 1-R or CFT 20-R (Weiß & Osterland, 2013; Weiß & Weiß, 2006).
  • •Parent reported diagnosis of the following: Serious physical illness or chronic diseases such as lung disease, heart disease, diabetes, hypertension, and rheumatic diseases; Neurological disorders including stroke, multiple sclerosis and epilepsy; indicated psychiatric disorders including obsessive-compulsive disorder, chronic tics, Tourette syndrome, and suicidal behavior.
  • •Prior participation in a BF/NF training.
  • •Other psychotherapeutic treatment or any kind of attention training, also in the course of an ergotherapeutic treatment, while participating in the study.

研究组 & 干预措施

NIRS-based NF in 3D

Active Comparator

A near-infrared spectroscopy (NIRS)-based neurofeedback training in which participants learn to increase the BOLD signal in prefrontal cortical regions will take place in a 3D virtual reality classroom environment.

干预措施: NIRS-based neurofeedback training (Behavioral)

NIRS-based NF in 2D

Active Comparator

A near-infrared spectroscopy (NIRS)-based neurofeedback training in which participants learn to increase the BOLD signal in prefrontal cortical regions will take place in a 2D (normal computer screen) classroom environment.

干预措施: NIRS-based neurofeedback training (Behavioral)

EMG-based BF in 3D

Active Comparator

An electromyogram (EMG)-based biofeedback training in which participants learn to self-regulate activity of the musculi supraspinatus will take place in a 3D virtual reality classroom environment.

干预措施: EMG-based biofeedback training (Behavioral)

结局指标

主要结局

ADHD symptomatology

时间窗: 9 months

ADHD symptomatology will be measured as evaluated by teachers and parents using the German long version of the Conners-3. Furthermore, data from accelerometer measures will provide information about motor hyperactivity. The SDQ and the KINDL will assess the children's and family's quality of life which is directly associated with ADHD symptomatology.

Activity in diverse cortical regions and parallel behavioral performance

时间窗: 9 months

The investigators measure prefrontal cortical activity using near-infrared spectroscopy and electroencephalography (EEG) during the verbal fluency task, the Go/NoGo and the n-back task. Behavioral performance on these tasks will also be assessed.

次要结局

  • Executive functions(9 months)
  • Academic performance(9 months)
  • Sustained attention(9 months)
  • Expectations of parents(9 months)
  • Motivation for the intervention(3-4 months)
  • Self-control and academic self-efficacy(9 months)

研究者

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

Dr. Ann-Christine Ehlis

Wissenschaftliche Leiterin der Arbeitsgruppe Psychophysiologie und Optische Bildgebung

University Hospital Tuebingen

研究点 (1)

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