Visit | V0 Pre-inclusion | V1 Inclusion and randomisation | Program (NVT or PMT) | V2 M1 | V3 M3 Follow-up |
---|---|---|---|---|---|
Day | D-90 to D0 | D0 | D1–D2 | D30 (\(\pm 15)\) = 1st booster session | V2 + 60 (\(\pm 15)\) days = 2nd booster session |
Protocol explanation | X | Â | Â | Â | Â |
Informed consent form | Â | X* | Â | Â | Â |
Inclusion/exclusion criteria | Â | X* | Â | Â | Â |
Demographic data | Â | X | Â | Â | Â |
Medication status | Â | X | Â | X | X |
Parent ratings and assessments | |||||
 ARI-parent |  | X* |  | X* | X* |
 CBCL |  | X* |  | X* | X* |
 PAFAS |  | X* |  | X* | X* |
 HiPIC |  | X* |  |  |  |
 5-minute speech sample (FMSS) |  | X* |  |  | X* |
 K-SADS | X |  |  |  |  |
 ICU |  | X* |  |  | X* |
Child ratings and assessments | |||||
 K-SADS | X |  |  |  |  |
 Cranky thermometers |  | X* |  | X* | X* |
Clinician ratings | |||||
 ARI – clinician |  | X* |  | X* | X* |
 CGI-I |  |  |  | X* | X* |
 CGI-S |  | X* |  |  |  |
 Presence at sessions |  |  |  | X* |  |