Attention deficit hyperactivity disorder (ADHD) Mental and Behavioural Disorders Hyperkinetic disorders
Conditions
Interventions
Participants will be randomly allocated to the following two groups (1:1 randomisation ratio):
Intervention group:
Neurofeedback of slow cortical potentials in addition to treatment as usual (TAU).
Sponsors
Ruhr-Universität Bochum (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria will be considered for admission to the trial: 1. Both males and females, aged 7 to less than 10 years inclusive 2. Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of ADHD, combined type 3. Ability of subject to understand character and individual consequences of clinical trial 4. Written informed consent must be available before enrolment in the trial 5. For women with childbearing potential, adequate contraception
Exclusion criteria
Exclusion criteria: 1. Below IQ 80 (Culture Fair Test [CFT]) 2. Bipolar disorder, psychosis, serious obsessive compulsive disorder (OCD), chronic serious tics or Tourette syndrome 3. Pharmacotherapy for severe anxiety and mood disorders and psychosis 4. Major neurological or medical illness 5. Non-German speaking child and primary caretaker 6. No telephone 7. Suicidal 8. Pregnancy and lactation 9. Participation in other clinical trials and observation period of competing trials, respectively
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ADHD Rating Scale at pre-test, treatment phase, post-test 1, post-test 2, follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed at pre-test, post-test 1, post-test 2, follow-up: 1. Clinical Global Impressions - Severity (CGI-S) Scale (at pre-test) and Clinical Global Impressions - Improvement (CGI-I) Scale (at post-test 1, post-test 2, follow-up) 2. Resumption of medication by choice of family during follow-up (yes/no) 3. Change in neuropsychological and neurophysiological parameters | — |
Countries
Germany
Outcome results
None listed