Comparison of neurofeedback and computerised attention skills training in children with attention-deficit/hyperactivity disorder (ADHD)
| ISRCTN | ISRCTN87071503 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87071503 |
| Secondary identifying numbers | MO-726/2 |
- Submission date
- 31/03/2008
- Registration date
- 15/05/2008
- Last edited
- 04/07/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Gunther Moll
Scientific
Scientific
University of Erlangen
Child & Adolescent Psychiatry
Schwabachanlage 6+10
Erlangen
D91054
Germany
| Phone | +49 (0)913 1853 9122 |
|---|---|
| Gunther.Moll@uk-erlangen.de |
Study information
| Study design | Randomised, controlled, multicentre clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Neurofeedback in children with attention-deficit/hyperactivity disorder: clinical efficacy and neurophysiological mechanisms |
| Study acronym | Neurofeedback - ADHD |
| Study objectives | 1. Neurofeedback training is more effective than a computerised attention training in children with attention-deficit/hyperactivity disorder (ADHD) 2. Neurophysiological mechanisms of a successful neurofeedback training can be revealed (distinct patterns for different neurofeedback protocols) |
| Ethics approval(s) | Ethics approval received from the Ethics Committee of the University of Erlangen on the 29th April 2004 (ref: 3135). |
| Health condition(s) or problem(s) studied | Attention-deficit/hyperactivity disorder (ADHD) |
| Intervention | Experimental intervention: neurofeedback training (comprising so-called theta/beta training and training of slow cortical potentials) Control intervention: computerised attention skill training Children are randomly assigned to one of the two trainings. Both trainings consist of two blocks of 18 sessions (double sessions of about 50 minutes each, separated by a short break), two to three double sessions a week. There is an intermission of about two to three weeks between the two blocks. In the training, the children develop strategies for focusing their attention and are instructed on how to practice these strategies at home and in school. |
| Intervention type | Other |
| Primary outcome measure | Changes from baseline to end of training in ADHD symptoms (German ADHD rating scale[FBB-HKS]). |
| Secondary outcome measures | Behavioural level (parent and teacher ratings): 1. Positive and negative attributes using the Strength and Difficulties Questionnaire (SDQ-D) 2. Oppositional behaviour and delinquent and physical agression (FBB-SSSV) 3. Behaviour problems of the child in specific home situations (HSQ-D); including homework (HPC-D) Neurophysiological level: 4. Brain electrical activity measures (electroencephalogram [EEG], event-related potentials) at rest and during computerised attention tasks All measures are assessed at baseline, between the two training blocks and at the end of training. Behavioural measures will additionally be assessed at the six-month follow-up. |
| Overall study start date | 01/05/2005 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Aged 8 - 12 years 2. Gender: both 3. Attention-deficit/hyperactivity disorder (ADHD) (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition [DSM IV] criteria: combined type or predominantly inattentive) 4. Children with the following associated disorders are allowed to participate: 4.1. Conduct disorders 4.2. Tic disorders 4.3. Emotional disorders 4.4. Dyslexia |
| Key exclusion criteria | 1. Comorbid disorders other than those mentioned in the inclusion criteria 2. Gross neurological or other organic disorders 3. Pharmacological treatment or other psychotherapies 4. Intelligence quotient (IQ) less than 80 |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 30/09/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
University of Erlangen
Erlangen
D91054
Germany
D91054
Germany
Sponsor information
University of Erlangen (Germany)
University/education
University/education
c/o Prof. Dr. Gunther Moll
Child and Adolescent Psychiatry
Schwabachanlage 6+10
Erlangen
D 91054
Germany
| Website | http://www.klinikum.uni-erlangen.de |
|---|---|
"ROR" |
https://ror.org/00f7hpc57 |
Funders
Funder type
Research organisation
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | main results | 01/07/2009 | Yes | No | |
| Results article | results on EEG effects | 01/11/2009 | Yes | No | |
| Results article | result | 01/05/2011 | Yes | No |
