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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Neurofeedback training
Computerized cognitive training
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, neurofeedback, computerized cognitive training, school

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ADHD (DSM IV)

Exclusion Criteria:

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

Sites / Locations

  • University Clinic of Child and Adolescent Psychiatry, University of Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Training in a school setting

Training in a clinical setting

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

ADHD behavioral symptoms
Primary outcome measures will be assessed by clinical scales (Conners 3), rated by parents and teachers.

Secondary Outcome Measures

Neuropsychological performance, EEG parameters
Computerized test battery for attention and working memory; Q-EEG, event related potentials

Full Information

First Posted
September 2, 2014
Last Updated
October 25, 2017
Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02358941
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, neurofeedback, computerized cognitive training, school

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training in a school setting
Arm Type
Experimental
Arm Description
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.
Arm Title
Training in a clinical setting
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Neurofeedback training
Intervention Description
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
Intervention Name(s)
Computerized cognitive training
Intervention Description
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 Outcome Measure Information:
Title
ADHD behavioral symptoms
Description
Primary outcome measures will be assessed by clinical scales (Conners 3), rated by parents and teachers.
Time Frame
Outcome assessment 6 months after baseline
Secondary Outcome Measure Information:
Title
Neuropsychological performance, EEG parameters
Description
Computerized test battery for attention and working memory; Q-EEG, event related potentials
Time Frame
Outcome assessment 6 months after baseline
Other Pre-specified Outcome Measures:
Title
Classroom behavior
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renate Drechsler, PhD
Organizational Affiliation
University Clinic of Child and Adolescent Psychiatry, University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic of Child and Adolescent Psychiatry, University of Zürich
City
Zurich
ZIP/Postal Code
CH- 8032
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31021250
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.
Results Reference
derived
PubMed Identifier
29765401
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.
Results Reference
derived

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

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