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Background: Aggressive challenging behaviour in people with intellectual disability (ID) is frequently treated with antipsychotic drugs, despite a limited evidence base., Method: A multi-centre randomised controlled trial was undertaken to investigate the efficacy, adverse effects and costs of two commonly prescribed antipsychotic drugs (risperidone and haloperidol) and placebo., Results: The trial faced significant problems in recruitment. The intent was to recruit 120 patients over 2 years in three centres and to use a validated aggression scale (Modified Overt Aggression Scale) score as the primary outcome. Despite doubling the period of recruitment, only 86 patients were ultimately recruited., Conclusions: Variation in beliefs over the efficacy of drug treatment, difficulties within multidisciplinary teams and perceived ethical concerns over medication trials in this population all contributed to poor recruitment. Where appropriate to the research question cluster randomised trials represent an ethically and logistically feasible alternative to individually randomised trials.

Background Reliable measures of aggressive challenging behaviour are required if interventions aimed at reducing this behaviour among people with intellectual disability (ID) are to be formally evaluated. The present authors examined the reliability of the Modified Overt Aggression Scale (MOAS), an instrument not yet formally tested in those with ID, in a sample of people who participated in a randomized trial of neuroleptic medication for aggressive challenging behaviour. Method Sixty interviews using the MOAS were carried out by two interviewers 2–5 days apart with 23 carers of 14 people who had shown aggressive challenging behaviour. Level of agreement between these two ratings was examined for four subscales of aggression and for total MOAS score. Results The level of agreement between the raters was high for verbal aggression (intraclass correlation coefficient, ICC = 0.90), physical aggression against others (ICC = 0.90) and for total MOAS score (ICC = 0.93). Levels of agreement on the other two subscales were lower but still in the good/moderate range. Conclusion The MOAS provides a reliable measure of verbal and physical aggression among people with ID who reside in community settings and is suitable for use in studies evaluating the effectiveness of interventions aimed at reducing aggressive challenging behaviour in this group. [ABSTRACT FROM AUTHOR]