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

NCT ID: NCT02358941

Last Updated: 2017-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2017-09-30

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD, neurofeedback, computerized cognitive training, school

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Training in a school setting

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.

Group Type: EXPERIMENTAL

Neurofeedback training

Intervention Type: 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

Intervention Type: 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.

Training in a clinical setting

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.

Group Type: EXPERIMENTAL

Neurofeedback training

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Renate Drechsler

PD Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renate Drechsler, PhD

Role: PRINCIPAL_INVESTIGATOR

University Clinic of Child and Adolescent Psychiatry, University of Zurich

Locations

University Clinic of Child and Adolescent Psychiatry, University of Zürich

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 31021250 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29765401 (View on PubMed)

Other Identifiers

SNF: 320030_149411/1

Identifier Type: -

Identifier Source: org_study_id