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. 2015 Apr 7;2015(4):CD003406. doi: 10.1002/14651858.CD003406.pub4

McPhail 1989.

Methods Randomised controlled trial
  • Setting: study conducted in Scotland; adult training centre

  • No study dates are given

Participants 12 participants (mean age 34 (35 in intervention group and 33 in control group) with mild‐to‐severe intellectual disabilities on BPVS (mean mental age in both groups was 7))
  • Participants who were eligible were judged to be disruptive by instructors and staff at a day centre as reported on a 10‐point severity scale of 17 disruptive behaviours. It would appear that the scale was developed for the study

Interventions Treatment 1: abbreviated progressive relaxation (n = 6)
  • Intervention was carried out by researchers who were familiar with the intervention

  • No fidelity checks of the intervention were carried out


Treatment 2: no treatment or "story reading" (n = 6)
Outcomes Behavioural rating scale, 10‐item checklist
Notes
  • Data in published paper omitted SD and we did not receive a response from contacting the authors

  • No information on source of funding

  • No declaration of conflicts of interest statement

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information provided. It is not clear how participants were randomised to treatment groups
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants and personnel were not blinded to group allocation
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessors were blinded to group allocation
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participants completed the intervention but data from 2 participants were removed from analysis; 1 participant from each group was removed from the analysis (1 was unwell for a week and the other showed no aggression at baseline). Quote: "One subject from each group was discarded from the analysis, one because she was ill for a week during treatment and the other because she showed almost no disruptive behaviour at baseline and throughout the study". The reasons provided for the removal of participants appear to be unrelated to the outcome
Selective reporting (reporting bias) High risk No data on the follow‐up study are presented in the paper, although the authors provide a reason for this. Quote: "The follow‐up study consisted of four observation sessions on two different days in two consecutive weeks, three months after the completion of the original study. Because of extensive changes within the centre, only three relaxation and three control group participants could be observed under similar conditions to that at the time of the original study"
Other bias Low risk No other sources of bias such as an imbalance of participant characteristics at baseline