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Table 2 Primary and secondary outcome measures

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)

ConceptInstrumentTime points for analysis modelType of measureSummary measure
ADHD symptomsConners Adult ADHD rating scale (CAARS), investigator ratedM (B, 4, 5, 8)Continuous scaleMean difference
Emotional dysregulationWender-Reimherr Adult ADHD Diagnostic Scale (WRAADS), investigator ratedM (B, 5, 8)Continuous scaleMean difference
IrritabilityAffective Reactivity Index (ARI), self-ratedM (B, 5, 8)Continuous scaleMean difference
Spontaneous mind wanderingMind Excessively Wandering Scale (MEWS), self-ratedM (B, 5, 8)Continuous scaleMean difference
Attitudes towards violenceMaudsley Violence Questionnaire (MVQ), self-ratedM (B, 5, 8)Continuous scaleMean difference
Common psychopathological symptomsBrief Symptom Inventory (BSI), self-ratedM (B, 5, 8)Continuous scaleMean difference
Global impression of disease severityClinical Global Impression (CGI) scale, clinician ratedM (B, 5, 8)CategoricalMean difference
Behavioural problems recorded by prison officers in prison recordsNumber of critical incidents recorded in prison recordsIncident rate (B, 8)Incident rate over 8-week periodIncidence rate ratio
Prison office ratings of aggressive behaviourModified Overt Aggression Scale (MOASP), Prison Officer reportM (B, 8)ContinuousMean difference
Educational staff ratings of aggressive behaviourModified Overt Aggression Scale (MOASE), Education Staff reportM (B, 8)aContinuousMean difference
Prison officer ratings of behaviourBehaviour Report Card (BRCP), Prison Officer reportM (B, 8)ContinuousMean difference
Educational ratings of behaviourBehaviour Report Card (BRCE), Educational Staff reportM (B, 8)aContinuousMean difference
Engagement with the educational programmeNumber of educational sessions attended over 8-week periodIncident rate (B, 8)aIncident rate over 8-week periodIncidence rate ratio
Incentive points for rewarding behaviourNumber of Incentives and Earned Privileges (IEPs)Incident rate (B, 8)Incident rate over 8-week periodIncidence rate ratio
Current psychological distressCORE Outcome Measure (CORE-OM), self-ratedM (8)ContinuousMean difference
  1. Notes on time points for analysis:
  2. M refers to modelling mean 8-week outcomes
  3. Numbers in brackets refer to the assessment time points of measures included in the model (B = baseline, 4 = week-4 data, 5 = week-5 data, 8 = week-8 data)
  4. For incident rate variables (e.g. number of behavioural problem reports) the baseline data are from the 8 weeks prior to randomisation; for the 8-week outcome the data are from the 8-week period from the start of medication
  5. aIndicates a measure completed for the subset of participants participating in education and related activities