Background
Methods
Patricipants and recruitment
Inclusion criteria | Attention-deficit/hyperactivity disorder (combined type) (DSM-IV) |
Being 7 to 9 years of age | |
Ability to understand character and individual consequences of the trial | |
Written informed consent of the person with primary custody must be available before enrolment in the trial | |
Exclusion criteria | Diagnosis of bipolar disorder, psychosis, serious OCD, chronic serious tics or Tourette syndrome |
Major neurological or medical illness | |
Pharmacotherapy for severe anxiety and mood disorders and psychosis | |
Acute suicidal tendencies | |
IQ below 80 (CPM) | |
Non-German speaking child and primary caretaker | |
No telephone | |
Pregnancy and lactation | |
Participation in other clinical trials and observation period of competing trials, respectively. |
Ethics and written consent
Interventions
Experimental group: feedback of slow cortical potentials
Control group: feedback of electromyographic activity of the musculi supraspinatus
Randomization and blinding
Assessments
FBB-ADHS
Clinical Global Impression Scale
Testbattery for Attentional Performance
Neurophysiological parameters: a) quantitative EEG and b) event related potentials
Child Behavior Checklist
Strengths and Difficulties Questionnaire
Coloured Progressive Matrices
Quality of life questionnaire
Parents’ expectations on-/satisfaction with therapy
Adverse events and serious adverse events
Time points of assessments
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Screening: Eligibility criteria are examined in a first appointment.
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Pre-test: After washing out the medication as outlined above the initial assessment is carried out to establish an unmedicated baseline.
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Post-test I: After 3 months of either neurofeedback or EMG-biofeedback, there is a comprehensive post-therapy assessment.
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Post-test II: One month later, a second comprehensive post-therapy assessment is provided. To compare an unmedicated state to the baseline (established in the Pre-test) again medication is washed out before.
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Follow-up-test: Six months after the training-phase has ended, another comprehensive assessment is carried out. Medication is washed out before.
Visit | Screening | Pre-test | Treatment Phase | Post-test I | Post-test II | Follow-up | Follow-up-test |
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Action | |||||||
Trial month | -1 | 0 | 1 to 3 | End of 3 | End of 4 | 5 to 9 | End of 9 |
FBB-ADHS (Parents) | X | X | XX | X | X | XXXX | X |
FBB-ADHS (Teacher) | X | X | X | ||||
CGI-S /I | X | X | X | X | X | ||
TAP | X | X | X | X | |||
QEEG, ERPs | X | X | X | X | |||
SDQ (Parents) | X | X | X | ||||
SDQ (Teacher) | X | ||||||
CPM /parallel | X | X | X | ||||
Kid-KINDL(R) | X | X | X | X | |||
Adverse events | Continuously | ||||||
Parents’ expectations/satisfaction | X | X | X | X | X | ||
EFB-K | X | ||||||
CBCL | X |
Primary and secondary endpoints
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CGI-I.
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Resumption of medication by choice of family during follow-up.
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Change in neuropsychological and neurophysiological parameters.
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Change in SDQ questionnaire subscales.
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Change of full-scale IQ in CMP.
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Change in KINDL(R) questionnaire (both parents and child version).
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Score measuring parents' satisfaction with therapy.