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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358941
• Other study ID #: SNF: 320030_149411/1
• Status: Completed
• Phase: N/A
• First received: September 2, 2014
• Last updated: October 25, 2017
• Start date: December 2013
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

Inclusion Criteria:

• ADHD (DSM IV)

Exclusion Criteria:

• Estimated IQ < 80

• Known neurological impairment / brain injury

• Severe comorbid conditions (e.g. CD, ODD, autism)

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	University Clinic of Child and Adolescent Psychiatry, University of Zürich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Classroom behavior	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.	Observation 1 approx. 2 weeks before the start of the training, observation 2 (endpoint) approx. 2 weeks after the end of the training
Primary	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	Neuropsychological performance, EEG parameters	Computerized test battery for attention and working memory; Q-EEG, event related potentials	Outcome assessment 6 months after baseline