Skip to main content
. 2020 Sep 3;2020(9):CD007667. doi: 10.1002/14651858.CD007667.pub3
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)) 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. 

  • 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)

  • Adverse events: dichotomous outcome, measured as incidence of overall adverse events and of the three most common adverse events, measured as numbers reporting:

    • sudden and unexpected death;

    • natural causes of death; or

    • self‐harm/injury.

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

  • Leaving the study early: continuous or dichotomous outcome, measured as proportion of participants discontinuing treatment:

    • for specific reasons (release, parole, move establishment, changes in security); or

    • for general reasons

  • 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

  • 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.

  • 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

Statistical results (reported means, standard deviation, standard errors, confidence intervals, F values or P values and range) for key variables: