Willner 2013.
Methods | Cluster‐randomised controlled trial of 30 centres (15 experimental and 15 control)
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Participants | Centres were eligible if:
179 participants with mild or moderate intellectual disabilities were included in study (90 in intervention arm and 89 in control arm)
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Interventions | Treatment group: manualised group cognitive‐behavioural anger management therapy
Control group: "treatment‐as‐usual", waiting list control group |
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Outcomes | Primary outcomes:
Secondary outcomes:
Other secondary measures included quality of life, depression, anxiety, self esteem, and service resource utilisation (using CSRI) |
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was based in 'minimisation' with a random component set at 80% |
Allocation concealment (selection bias) | Low risk | Not an issue as clusters were all randomised at the same time |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and study personnel were not blinded to the allocation group. Key worker reports were provided by staff who had not been the 'lay therapist' but this was not possible in all cases (n = 14) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The assessors were blinded to the allocation group but the authors report "although this may have been compromised by incidental comments from respondents during data collection". However, the authors believe that this risk was small |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Number of participants who withdrew from study are reported. At 10 months retention rate was 81% (projected 80%) with same number of dropouts in both arms (17 dropouts). Results were analysed according to intention‐to‐treat. 80% of key workers retained at 10‐month follow‐up but only 60% of home carers were retained at follow‐up |
Selective reporting (reporting bias) | Low risk | All prespecified the outcomes were reported |
Other bias | Unclear risk | Authors had a strong allegiance to the intervention and their desire for the intervention to succeed could have affected data collection, but the likelihood of this impacting the results is unclear |
BPVS: British Picture Vocabularly Scale. CSRI: Client Service Receipt Inventory. IQ: intelligence quotient. MHA: Mental Health Act. NHS: National Health Service. NIHR: National Institute for Health Research. SD: standard deviation. WAIS: Wechsler Adult Intelligence Scale. WAIS‐III: Wechsler Adult Intelligence Scale, Third Edition. WAIS‐R: Wechsler Adult Intelligence Scale, Revised. WASI: Wechesler Abbreviated Scale of Intelligence.