Visit | 2 | 3 | 4 | Randomisation and Initiation of treatment | 5 | 6 | 7 | 8 | 9 | 10 |
---|---|---|---|---|---|---|---|---|---|---|
Consent, randomisation and initiation of treatment | ||||||||||
 Informed consent | X |  |  |  |  |  |  |  |  |  |
 Eligibility checks |  |  | X |  |  |  |  |  |  |  |
 Randomisation and initiation of treatment |  |  |  | X |  |  |  |  |  |  |
Treatment with OROS-MPH or placebo | ||||||||||
 Treatment with OROS-MPH or placebo |  |  |  | X | X | X | X | X | X | X |
Baseline (pre-randomisation), titration (visit 5-7), mediator (visit 9) and outcome (visit 10) measures | ||||||||||
 DIVA (taken from pre-trial records) |  | X |  |  |  |  |  |  |  |  |
 MINI 7.0.1 diagnostic interview |  | X |  |  |  |  |  |  |  |  |
 MINI 7.0.1 cross disorder symptom ratings |  | X |  |  |  |  |  |  |  | X |
 Demographic data |  | X |  |  |  |  |  |  |  |  |
 WASI-II (general cognitive ability) |  | X |  |  |  |  |  |  |  |  |
 RPAQ |  | X |  |  |  |  |  |  |  |  |
 CTQ |  | X |  |  |  |  |  |  |  |  |
 Drug and alcohol use (AUDIT-C and NIDA) |  | X |  |  |  |  |  |  |  |  |
 ZAN-BPD |  | X |  |  |  |  |  |  |  |  |
 CAARS –O |  | X |  |  | X | X | X | X | X | X |
 AES |  |  | X |  | X | X | X | X | X | X |
 Blood pressure and pulse |  | X |  |  | X | X | X | X | X | X |
 WRAADS |  | X |  |  |  |  |  |  | X | X |
 ARI-S |  | X |  |  |  |  |  |  | X | X |
 MEWS |  | X |  |  |  |  |  |  | X | X |
 Demographic data |  | X |  |  |  |  |  |  |  |  |
 MVQ |  | X |  |  |  |  |  |  |  | X |
 BSI |  | X |  |  |  |  |  |  |  | X |
 CGI |  | X |  |  |  |  |  |  |  | X |
 Weiss-CD |  | X |  |  |  |  |  |  |  |  |
 Weight |  | X |  |  |  |  |  |  | X | X |
 Number of critical Incidents (adjudications)b |  | X |  |  |  |  |  |  |  | X |
 MOASP |  | X |  |  |  |  |  |  |  | X |
 MOASE |  | O |  |  |  |  |  |  |  | O |
 BRCP |  | X |  |  |  |  |  |  |  | X |
 BRCE |  | O |  |  |  |  |  |  |  | O |
 Educational engagement (proportion of education sessions attended)b |  | O |  |  |  |  |  |  |  | O |
 Positive and negative IEPs (HMP ISIS only)b |  | X |  |  |  |  |  |  |  | X |
 CORE-M |  | X |  |  |  |  |  |  |  | X |
 Concomitant medications and compliancea |  | X | X |  | X | X | X | X | X | X |
 Prescribed dose of trial medication and compliancea |  |  |  |  | X | X | X | X | X | X |
 Withdrawal status |  |  |  |  | X | X | X | X | X | X |
 Study medication guess |  |  |  |  |  |  |  |  |  | X |