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Table 1 Table caption

From: Randomised controlled trial of the short-term effects of OROS-methylphenidate on ADHD symptoms and behavioural outcomes in young male prisoners with attention-deficit/hyperactivity disorder (CIAO-II)

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

  1. X indicates a measure which should always be recorded; O indicates a measure completed for a subset of participants participating in education and related activities; ataken from prescription records; btaken from
  2. Abbreviations: DIVA Diagnostic interview for adult ADHD, MINI-7.0.1 MINI international psychiatric interview for common mental health disorders, WASI-II Wechsler Abbreviated Scale of Intelligence-II, RPAQ Reactive proactive aggression questionnaire, CTQ Childhood trauma questionnaire, AUDIT-C Alcohol use screening test, NIDA NIDA quick drug screen, ZAN-BPD Zanarini borderline personality disorder scale, CAARS-O Observer rated DSM-IV ADHD, AES Adverse events scale, WRAADS Wender-Reimherr Adult ADHD Diagnostic Scale, ARI-S Affective reactivity index, MEWS Mind Excessively Wandering Scale, MVQ Maudsley violence questionnaire, BSI Brief symptom inventory, CGI Clinical global impression scale, Weiss-CD Conduct disorder scale, MOASP Modified overt aggression scale by prison officers, MOASE Modified overt aggression scale by education staff, BRCP Behaviour report cards by prison officers, BRCE Behaviour report cards by education staff, IEPs Incentive and Earned Privileges, CORE-M CORE outcome measure