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

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Behavioral: Neurofeedback training; Behavioral: Computerized cognitive training

• Registration Number: NCT02358941
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-09
• Primary Completion: 2017-03
• Study Completion: 2017-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• ADHD (DSM IV)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training in a clinical setting	Computerized cognitive training	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.
Training in a school setting	Neurofeedback training	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.
Training in a school setting	Computerized cognitive training	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.
Training in a clinical setting	Neurofeedback training	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Clinic of Child and Adolescent Psychiatry, University of Zürich; 🇨🇭 Zurich, Switzerland