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)

Asherson, Philip; Johansson, Lena; Holland, Rachel; Fahy, Tom; Forester, Andrew; Howitt, Sheila; Lawrie, Stephen; Strang, John; Young, Susan; Landau, Sabine; Thomson, Lindsay

doi:10.1186/s13063-019-3705-9

Trials

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)

Concept	Instrument	Time points for analysis model	Type of measure	Summary measure
ADHD symptoms	Conners Adult ADHD rating scale (CAARS), investigator rated	M (B, 4, 5, 8)	Continuous scale	Mean difference
Emotional dysregulation	Wender-Reimherr Adult ADHD Diagnostic Scale (WRAADS), investigator rated	M (B, 5, 8)	Continuous scale	Mean difference
Irritability	Affective Reactivity Index (ARI), self-rated	M (B, 5, 8)	Continuous scale	Mean difference
Spontaneous mind wandering	Mind Excessively Wandering Scale (MEWS), self-rated	M (B, 5, 8)	Continuous scale	Mean difference
Attitudes towards violence	Maudsley Violence Questionnaire (MVQ), self-rated	M (B, 5, 8)	Continuous scale	Mean difference
Common psychopathological symptoms	Brief Symptom Inventory (BSI), self-rated	M (B, 5, 8)	Continuous scale	Mean difference
Global impression of disease severity	Clinical Global Impression (CGI) scale, clinician rated	M (B, 5, 8)	Categorical	Mean difference
Behavioural problems recorded by prison officers in prison records	Number of critical incidents recorded in prison records	Incident rate (B, 8)	Incident rate over 8-week period	Incidence rate ratio
Prison office ratings of aggressive behaviour	Modified Overt Aggression Scale (MOASP), Prison Officer report	M (B, 8)	Continuous	Mean difference
Educational staff ratings of aggressive behaviour	Modified Overt Aggression Scale (MOASE), Education Staff report	M (B, 8)^a	Continuous	Mean difference
Prison officer ratings of behaviour	Behaviour Report Card (BRCP), Prison Officer report	M (B, 8)	Continuous	Mean difference
Educational ratings of behaviour	Behaviour Report Card (BRCE), Educational Staff report	M (B, 8)^a	Continuous	Mean difference
Engagement with the educational programme	Number of educational sessions attended over 8-week period	Incident rate (B, 8)^a	Incident rate over 8-week period	Incidence rate ratio
Incentive points for rewarding behaviour	Number of Incentives and Earned Privileges (IEPs)	Incident rate (B, 8)	Incident rate over 8-week period	Incidence rate ratio
Current psychological distress	CORE Outcome Measure (CORE-OM), self-rated	M (8)	Continuous	Mean difference

Notes on time points for analysis:
M refers to modelling mean 8-week outcomes
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)
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
^aIndicates a measure completed for the subset of participants participating in education and related activities

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ISSN: 1745-6215

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