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Completed

NCT Number: NCT02358941

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

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.

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Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic of Child and Adolescent Psychiatry, University of Zürich

Zurich, CH- 8032, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ADHD (DSM IV)

Exclusion criteria

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

Treatment and study plan

Neurofeedback training

Behavioral

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.

Computerized cognitive training

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2015
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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