Neurofeedback and Computerized Cognitive Training in Different Settings for Children and Adolescents With ADHD
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| ClinicalTrials.gov Identifier: NCT02358941 |
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Recruitment Status :
Completed
First Posted : February 9, 2015
Last Update Posted : October 26, 2017
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Attention deficit/hyperactivity disorder (ADHD) is among the most common childhood-onset psychiatric disorders, with a negative and long-lasting impact on academic achievement, social integration and quality of life. In recent years, the efficacy of non-pharmacological treatments for ADHD, such as neurofeedback training (NF) and computerized cognitive training (CCT), has been at the centre of research. Although an increasing number of well-designed studies have shown that both methods may improve ADHD core symptoms according to parents' ratings, the underlying mechanisms are still a matter of debate. Teachers often report smaller improvements, if any. This has been explained by their lesser involvement in the training. It remains questionable, however, whether other factors may also account for this effect and whether methods other than placebo control may be applied in order to demonstrate the specificity and efficacy of NF and CCT.
The main purpose of this project is to demonstrate and compare the efficacy of two different computer-based treatment methods for children and adolescents with ADHD, namely NF and CCT, and to examine the impact of different treatment settings, with half of the participants being trained in a clinical setting and the other half at school. The investigators want to show that is feasible to implement NF and CCT in a school setting and that both methods, conducted either at school or in a clinical setting, may lead to significant improvements of ADHD symptoms as well as to specific and differential effects. Besides the differential impact of the settings on informant ratings, the investigators will evaluate the effects of the training methods on neuropsychological and electrophysiological outcome. Classroom behavior of the children before and after the training will be evaluated by trained observers not informed on treatment assignments and settings.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Attention Deficit Hyperactivity Disorder | Behavioral: Neurofeedback training Behavioral: Computerized cognitive training | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 102 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Care Provider) |
| Primary Purpose: | Treatment |
| Official Title: | Neurofeedback and Computerized Cognitive Training in Different Settings for Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD) |
| Study Start Date : | December 2013 |
| Actual Primary Completion Date : | March 2017 |
| Actual Study Completion Date : | September 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Training in a school setting
A minimum of 30 sessions (45 min.) over at least 12 weeks in the schools of the participants. Half of the children will be assigned to NF training, the other half to CCT. |
Behavioral: Neurofeedback training
In neurofeedback training, EEG-activity is visualized and fed back to the participant online on a computer screen. Successful regulation is rewarded by bonus points. The aim is to gain control over one's brain activity and to be able to switch to or to maintain a more wakeful, alert or focussed state. Behavioral: Computerized cognitive training In computerized cognitive training, impaired neuropsychological functions, such as inhibition, working memory, distractibility, are directly trained by adaptive computerized software programs. We use training programs from a scientifically based training system for patients presenting problems with sustained, focussed or selective attention, working memory, inhibition, processing speed. Good performance / improvements are rewarded with bonus points. |
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Experimental: Training in a clinical setting
A minimum of 30 sessions (45 min.) over approx. 12 weeks at the Department of Child and Adolescent Psychiatry (treatment as usual). Half of the children will be assigned to NF training, the other half to CCT. |
Behavioral: Neurofeedback training
In neurofeedback training, EEG-activity is visualized and fed back to the participant online on a computer screen. Successful regulation is rewarded by bonus points. The aim is to gain control over one's brain activity and to be able to switch to or to maintain a more wakeful, alert or focussed state. Behavioral: Computerized cognitive training In computerized cognitive training, impaired neuropsychological functions, such as inhibition, working memory, distractibility, are directly trained by adaptive computerized software programs. We use training programs from a scientifically based training system for patients presenting problems with sustained, focussed or selective attention, working memory, inhibition, processing speed. Good performance / improvements are rewarded with bonus points. |
- ADHD behavioral symptoms [ Time Frame: Outcome assessment 6 months after baseline ]Primary outcome measures will be assessed by clinical scales (Conners 3), rated by parents and teachers.
- Neuropsychological performance, EEG parameters [ Time Frame: Outcome assessment 6 months after baseline ]Computerized test battery for attention and working memory; Q-EEG, event related potentials
- Classroom behavior [ Time Frame: Observation 1 approx. 2 weeks before the start of the training, observation 2 (endpoint) approx. 2 weeks after the end of the training ]
Standardized classroom observations of the participating children are conducted by a trained observer blind to whether the participant has already been trained or not and to which of the two training methods he has been allocated to.
With regard to this measure, it is a single blind study with blinding of the assessor.
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| Ages Eligible for Study: | 8 Years to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ADHD (DSM IV)
Exclusion Criteria:
- Estimated IQ < 80
- Known neurological impairment / brain injury
- Severe comorbid conditions (e.g. CD, ODD, autism)
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): NCT02358941
| Switzerland | |
| University Clinic of Child and Adolescent Psychiatry, University of Zürich | |
| Zurich, Switzerland, CH- 8032 | |
| Principal Investigator: | Renate Drechsler, PhD | University Clinic of Child and Adolescent Psychiatry, University of Zurich |
| Responsible Party: | Renate Drechsler, PD Dr., University of Zurich |
| ClinicalTrials.gov Identifier: | NCT02358941 |
| Other Study ID Numbers: |
SNF: 320030_149411/1 |
| First Posted: | February 9, 2015 Key Record Dates |
| Last Update Posted: | October 26, 2017 |
| Last Verified: | October 2017 |
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ADHD, neurofeedback, computerized cognitive training, school |
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Hyperkinesis Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders |
Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases |