A Biofeedback Training in Schoolchildren With an Attention-Deficit/Hyperactivity Disorder (ADHD)
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|ClinicalTrials.gov Identifier: NCT02572180|
Recruitment Status : Unknown
Verified June 2016 by Dr. Ann-Christine Ehlis, University Hospital Tuebingen.
Recruitment status was: Recruiting
First Posted : October 8, 2015
Last Update Posted : June 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Attention-deficit Hyperactivity Disorder of Childhood or Adolescence Nos||Behavioral: EMG-based biofeedback training Behavioral: NIRS-based neurofeedback training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Biofeedback Training in Schoolchildren With an Attention-Deficit/Hyperactivity Disorder (ADHD): Differential Effects of Training in a 2D or 3D Environment|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2017|
Active Comparator: NIRS-based NF in 3D
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.
Behavioral: NIRS-based neurofeedback training
Active Comparator: NIRS-based NF in 2D
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.
Behavioral: NIRS-based neurofeedback training
Active Comparator: EMG-based BF in 3D
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.
Behavioral: EMG-based biofeedback training
- ADHD symptomatology [ Time Frame: 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 [ Time Frame: 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.
- Executive functions [ Time Frame: 9 months ]Using a variety of neuropsychological tests, the investigators aim at testing executive functioning using a digit span task, a matrices span task, the corsi block tapping task, and the stop signal task. Furthermore, parents and teachers will evaluate executive functioning with the BRIEF.
- Academic performance [ Time Frame: 9 months ]Academic performance in math and German will be assessed using an age-appropriate version of the LVD-M 2-4 and the SLRT-II.
- Sustained attention [ Time Frame: 9 months ]Sustained attention will be measured using the Conner's continuous performance task (CPT).
- Self-control and academic self-efficacy [ Time Frame: 9 months ]
These variables are assessed using adapted versions of the following questionnaires:
- Brief version of the self-control scale (for parents and children)
- Questionnaire on academic self-efficacy
- Expectations of parents [ Time Frame: 9 months ]The expectations of parents on the bio- and neurofeedback interventions will be assessed using an adapted version of the FERT.
- Motivation for the intervention [ Time Frame: 3-4 months ]Motivation of the participants for the intervention will be assessed directly before every training session starts using a short self-assessment mainkin. Furthermore, an electrocardiogram (ECG) allows the investigators to measure the heart-rate variability which is hypothesized to be directly associated with motivation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572180
|Contact: Friederike Blume||+49707129 ext email@example.com|
|Contact: Justin Hudak, M.Sc.||+49707129 ext firstname.lastname@example.org|
|Principal Investigator:||Ann-Christine Ehlis, Dr.||Psychiatry and Psychotherapy (Uni Tübingen)|
|Principal Investigator:||Caterina Gawrilow, Prof.||School Psychology (Uni Tübingen)|
|Principal Investigator:||Thomas Dresler, Dr.||LEAD Graduate School|
|Principal Investigator:||Tobias J Renner, Prof.||Child and Adolescence Psychiatry (Uni Tübingen)|