Methods |
Allocation: Blinding: Duration of trial: Duration of participation: Setting: Phases: Intended follow‐up period: Validated instruments used: Unvalidated instruments used: |
Participants |
Number of participants screened: |
Control group Method of recruitment of participants: Number of participants included: (male, female) Number of participants followed up: Number of withdrawals: (reason) Diagnosis of ASPD: DSM/ICD Means of assessment: Age: mean years (range) IQ: Medication naive: % Ethnicity: Pre‐existing substance misuse: specify if drugs/alcohol Other comorbid diagnoses: Comedication: |
Experimental group Method of recruitment of participants: Number of participants included: (male, female) Number of participants followed up: Number of withdrawals: (reason) Diagnosis of ASPD: DSM/ICD Means of assessment: Age: mean years (range) IQ: Medication naive: % Ethnicity: Pre‐existing substance misuse: Other comorbid diagnoses: Comedication: |
Inclusion criteria met |
Exclusion criteria met |
Interventions |
Experimental group Medication name: Medication type: (e.g. neuroleptic/antipsychotic) No. randomised to group: Mean medication dosage: Mode of delivery: Administration schedule: Duration: days/weeks/months Level of therapeutic dose (is treatment dose >/< than this?): Washout before study initiation: hours before testing¨ Titration period: duration Adherence to treatment regime: |
Control/comparison group Comparison name: Medication type (if applicable): No. randomised to group: Mean medication dosage: Mode of delivery: Administration schedule: Duration: days/weeks/months Washout before study initiation: hours before testing¨ Titration period: duration Adherence to treatment regime: |
Outcomes (if possible, identify if outcomes are immediate (within 6 months), short term (> 6 months to 24 months), medium term (> 24 months to 5 years) and long term (beyond 5 years))
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Primary
Aggression (state or trait): reduction in aggressive behaviour or aggressive feelings; continuous outcome or dichotomous outcome, measured through improvement in scores on the Aggression Questionnaire (Buss 1992), the Modified Overt Aggression Scale (Malone 1994), or a similar, validated instrument; or as number of observed incidents
Recidivism: continuous, dichotomous or time‐to‐event outcome depending on how these data are reported, measured as reconviction in terms of the overall reconviction rate or numbers reconvicted for the sample (continuous), time to reconviction/reoffending (time‐to‐event data), recidivism yes/no (dichotomous). Non‐convicted offences identified by self‐report/incident reporting etc. reported in the same way.
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Global state/functioning: continuous outcome, measured through improvement on the Global Assessment of Functioning numeric scale (DSM‐IV‐TR)
Relapse
Time to relapse
No clinically important change in global state
Not any change in global state
Average endpoint global state score
Average change in global state scores
Social functioning: continuous or dichotomous outcome, measured through improvement in scores on the Social Adjustment Scale (Weissman 1976), the Social Functioning Questionnaire (Tyrer 2005), or a similar, validated instrument; or a proxy measure of social functioning (e.g. decreased level of support required/time taken to achieve leave from hospital)
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Adverse events: dichotomous outcome, measured as incidence of overall adverse events and of the three most common adverse events, measured as numbers reporting:
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Secondary
Quality of life: self‐reported improvement in overall quality of life; continuous outcome, measured through improvement in scores on the European Quality Of Life instrument (EuroQoL Group 1990), or a similar, validated instrument
Engagement with services: health‐seeking engagement with services; continuous outcome, measured though improvement in scores on the Service Engagement Scale (Tait 2002), or a similar, validated instrument
Satisfaction with treatment: continuous outcome, measured through improvement in scores on the Client Satisfaction Questionnaire (Attkisson 1982), or a similar, validated instrument
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Leaving the study early: continuous or dichotomous outcome, measured as proportion of participants discontinuing treatment:
Substance misuse: continuous or dichotomous outcome, measured as improvement on the Substance Use Rating Scale, patient version (Duke 1994), or a similar, validated instrument
Employment status: continuous outcome, measured as number of days in employment over the assessment period
Housing/accommodation status: continuous outcome, measured as number of days living in independent housing/accommodation over the assessment period
Economic outcomes: continuous outcome, reporting direct costs and indirect costs
Impulsivity (state or trait): self‐reported improvement in impulsivity; continuous outcome, measured through reduction in scores on the Barratt Impulsivity Scale (Patton 1995), or a similar, validated instrument
Anger: self‐reported improvement in anger expression and control; continuous outcome, measured through reduction in scores on the State‐Trait Anger Expression Inventory‐2 (Spielberger 1999), or a similar, validated instrument
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Mental state: continuous outcome reporting:
general mental state;
no clinically important change in general mental state;
not any change in general mental state;
average endpoint general mental state score; or
average change in general mental state scores.
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Prison and service outcomes: continuous outcome reporting:
treatment of people in the community;
duration of treatment programme; or
changes in services provided by through care/probation teams
Other
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Statistical results (reported means, standard deviation, standard errors, confidence intervals, F values or P values and range) for key variables: |