Visit | Pre-inclusion | Inclusion | Discovery or open titration | Treatment period (MPH or NFB) | ||||
---|---|---|---|---|---|---|---|---|
Initial discovery or titration | Discovery or titration | Discovery or titration | Final discovery or titration | Intermediate | Final | |||
Day | D-90 to D-1 | D0 | D7 ± 3 | D14 ± 3 | D21 ± 3 | D28 ± 3 | D60 ± 7 | D90 ± 10 |
Protocol explanation | X | |||||||
Inform consent form | X | |||||||
Inclusion/exclusion criteria | X | |||||||
Demographic data | X | |||||||
Medical/surgical history | X | |||||||
Medical examination | X | |||||||
qEEG | X | X | X | |||||
Randomisation | X | |||||||
MPH delivery | X | X | X | X | X | |||
NFB discovery session | X | X | X | X | X | |||
Kiddie-Sads | X | |||||||
ADHD RS parents | X | X | X | |||||
ADHD RS clinician | X | X | X | |||||
ADHD RS teacher | X | X | ||||||
CGI-I score | X | X | X | X | X | X | ||
CGI-S score | X | X | X | X | X | X | X | |
C-SSRS (Columbia suicide rating scale | X | X | X | X | X | X | X | |
SDSC | X | X | X | X | X | X | X | |
SDQ by teacher/parent | X | X | ||||||
BRIEF | X | X | ||||||
Conners 3 CPT | X | X | ||||||
WASI 3 subtest (or WISC less 3 months) | X | |||||||
Concomitant treatments | X | X | X | X | X | X | X | |
Adverse event collection (spontaneous) | X | X | X | X | X | X | ||
PAERS questionnaire | X | X | X | X | X | X | X |