Clinical trial NCT02358941: Neurofeedback and Computerized Cognitive Training in Different Settings for Children and Adolescents With ADHD
Official title: Neurofeedback and Computerized Cognitive Training in Different Settings for Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD, neurofeedback, computerized cognitive training, school
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2015-02-09
Enrollment: 102
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* ADHD (DSM IV)

Exclusion Criteria:

* Estimated IQ \< 80
* Known neurological impairment / brain injury
* Severe comorbid conditions (e.g. CD, ODD, autism)

Primary outcomes:
measure: ADHD behavioral symptoms
timeFrame: Outcome assessment 6 months after baseline
Secondary outcomes:
measure: Neuropsychological performance, EEG parameters
timeFrame: Outcome assessment 6 months after baseline
Other outcomes:
measure: Classroom behavior
timeFrame: Observation 1 approx. 2 weeks before the start of the training, observation 2 (endpoint) approx. 2 weeks after the end of the training
Locations:
city: Zurich
country: Switzerland
facility: University Clinic of Child and Adolescent Psychiatry, University of Zürich
Study officials:
affiliation: University Clinic of Child and Adolescent Psychiatry, University of Zurich
name: Renate Drechsler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Minder F, Zuberer A, Brandeis D, Drechsler R. Specific Effects of Individualized Cognitive Training in Children with Attention-Deficit/Hyperactivity Disorder (ADHD): The Role of Pre-Training Cognitive Impairment and Individual Training Performance. Dev Neurorehabil. 2019 Aug;22(6):400-414. doi: 10.1080/17518423.2019.1600064. Epub 2019 Apr 25.
citation: Zuberer A, Minder F, Brandeis D, Drechsler R. Mixed-Effects Modeling of Neurofeedback Self-Regulation Performance: Moderators for Learning in Children with ADHD. Neural Plast. 2018 Mar 22;2018:2464310. doi: 10.1155/2018/2464310. eCollection 2018.