Neurofeedback and Computerized Cognitive Training in Different Settings for Children and Adolescents With ADHD

Study Overview
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Brief Summary
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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.

Official Title
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Neurofeedback and Computerized Cognitive Training in Different Settings for Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD)

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Neurofeedback training
* Behavioral: Computerized cognitive training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ADHD (DSM IV) Exclusion Criteria: Estimated IQ < 80 Known neurological impairment / brain injury Severe comorbid conditions (e.g. CD, ODD, autism)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training in a school setting<br>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<br>* 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.<br>Behavioral: Computerized cognitive training<br>* 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.<br>|
| Experimental: Training in a clinical setting<br>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<br>* 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.<br>Behavioral: Computerized cognitive training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD behavioral symptoms | Primary outcome measures will be assessed by clinical scales (Conners 3), rated by parents and teachers. | Outcome assessment 6 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological performance, EEG parameters | Computerized test battery for attention and working memory; Q-EEG, event related potentials | Outcome assessment 6 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, neurofeedback, computerized cognitive training, school