Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Biofeedback Training in Schoolchildren With an Attention-Deficit/Hyperactivity Disorder (ADHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Dr. Ann-Christine Ehlis, University Hospital Tuebingen

Brief Summary:
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).

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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Sustained attention [ Time Frame: 9 months ]
    Sustained attention will be measured using the Conner's continuous performance task (CPT).

  4. Self-control and academic self-efficacy [ Time Frame: 9 months ]

    These variables are assessed using adapted versions of the following questionnaires:

    1. Brief version of the self-control scale (for parents and children)
    2. Questionnaire on academic self-efficacy

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Going to school Grade 1-4.
  • 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.

Exclusion Criteria:

  • Not going to school or in other Grades than 1-4.
  • 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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Friederike Blume +49707129 ext 75633 friederike.blume@uni-tuebingen.de
Contact: Justin Hudak, M.Sc. +49707129 ext 82315 justin.hudak@lead.uni-tuebingen.de

Locations
Layout table for location information
Germany
LEAD Graduate School Recruiting
Tuebingen, Baden-Wuerttemberg, Germany, 72074
Contact: Friederike Blume    +49707129 ext 75633    friederike.blume@uni-tuebingen.de   
Contact: Justin Hudak, M.Sc.    +49707129 ext 82315    justin.hudak@lead.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Layout table for investigator information
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)
Publications:
American Psychiatric Association. (2013). DSM-5 Attention Deficit/ Hyperactivity Disorder Fact Sheet. American Psychiatric Association. Retrieved from www.dsm5.org
Bertrams, A., & Dickhäuser, O. (2009). Messung dispositioneller Selbstkontroll-Kapazität. Diagnostica, 55(1), 2-10. doi:10.1026/0012-1924.55.1.2
Corsi, P. M. (1973). Human Memory and the Medial Temporal Region of the Brain. Dissertation Abstracts International, 34(2-B), 891.
Drechsler, R., & Steinhausen, H.-C. (2013). BRIEF. Verhaltensinventar zur Beurteilung exekutiver Funktionen. Göttingen: Hogrefe Verlag.
Lidzba, K., Christiansen, H., & Drechsler, R. (2013). Conners Skalen zu Aufmerksamkeit und Verhalten-3. Deutschsprachige Adaption der Conners 3rd edition von Keith Conners. Bern: Huber.
Moll, K., & Landerl, K. (2014). Lese- und Rechtschreibtest (SLRT-II). Weiterentwicklung des Salzburger Lese- und Rechtschreibtests (SLRT) (2., korrig.). Bern: Verlag Hans Huber.
Schwarzer, R., & Jerusalem, M. (1999). Skalen zur Erfassung von Lehrer-und Schüler-merkmalen. Dokumentation der psychometrischen Verfahren im Rahmen der Wissenschaftlichen Begleitung des Modellversuchs Selbstwirksame Schulen. Berlin.
Verbruggen, F., Logan, G. D., & Stevens, M. A. (2013). STOP-IT. Retrieved from http://www.psy.vanderbilt.edu/faculty/logan/#stopit
Vollmann, K., Hautzinger, M., & Strehl, U. (2009). Entwicklung und Überprüfung eines Fragebogens zur Erfassung relevanter Therapiebedingungen (FERT) [dissertation]. Tübingen (Deutschland): Eberhard-Karls-Universität Tübingen.
Weiß, R. H., & Osterland, J. (2013). CFT 1-R. Grundintelligenztest Skala 1 - Revision -. Göttingen: Hogrefe Verlag.
Weiß, R. H., & Weiß, B. (2006). CFT 20-R. Grundintelligenztest Skala 2 - Revision -. Göttingen: Hogrefe Verlag.
Conners, C. K., & Sitarenios, G. (2011). Conners' Continuous Performance Test (CPT). In J. Kreutzer, J. DeLuca, & B. Caplan (Eds.), Encyclopedia of Clinical Neuropsychology SE - 1535 (pp. 681-683). Springer New York. doi:10.1007/978-0-387-79948-3_1535
Strathmann, A. M., & Klauer, K. J. (2012). LVD-M 2-4 Lernverlaufsdiagnostik für zweite bis vierte Klassen. Göttingen: Hogrefe.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr. Ann-Christine Ehlis, Wissenschaftliche Leiterin der Arbeitsgruppe Psychophysiologie und Optische Bildgebung, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02572180    
Other Study ID Numbers: LEAD_BluHud_524
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases