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

NCT02358941 | Completed

• 1 other identifier: SNF: 320030_149411/1
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Neuropsychological performance, EEG parameters

  Outcome assessment 6 months after baseline

Other Outcomes (1)

• Classroom behavior

  Observation 1 approx. 2 weeks before the start of the training, observation 2 (endpoint) approx. 2 weeks after the end of the training

Study Arms (2)

Training in a school setting

EXPERIMENTAL

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.

Behavioral: Neurofeedback training; Behavioral: Computerized cognitive training

Training in a clinical setting

EXPERIMENTAL

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.

Behavioral: Neurofeedback training; Behavioral: Computerized cognitive training

Interventions

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.

Training in a clinical setting; Training in a school setting

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.

Training in a clinical setting; Training in a school setting

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ADHD (DSM IV)

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

University Clinic of Child and Adolescent Psychiatry, University of Zürich

Zurich, CH- 8032, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 31021250 DERIVED

• 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.

  PMID: 29765401 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Renate Drechsler, PhD

  University Clinic of Child and Adolescent Psychiatry, University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: February 9, 2015
• Study Start: December 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

CH (1)