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

Singh 2013.

Methods Randomised controlled trial
  • Setting: study conducted in the USA; participants were living in community settings

  • No study dates were given

Participants
  • Eligibility criteria: 4 or more incidents of aggression in the last 12 weeks, and the incidents had to be severe enough to cause pain or require first aid

  • 34 participants with mild intellectual disabilities were included (17 in each group)

  • Aged 17 ‐ 34 years. Mean age of intervention group 23.4 years; mean age of control group 23.1 years

  • 7 were women (4 in intervention group; 3 in control group)

Interventions
  • Experimental group: 12 weeks of baseline (no intervention: phase 1), followed by 12 weeks of mindfulness training (Meditation on the Soles of the Feet: phase 2), followed by follow‐up for 12 weeks (phase 3), and then another 12 weeks (phase 4)

  • Carers and support staff were taught to use mindfulness techniques in their daily lives by an experienced trainer

  • During the 12‐week intervention phase, carers and support staff taught individuals with intellectual disabilities to use mindfulness. This involved 15‐ to 30‐minute sessions with the individual everyday, based on a manual. The initial teaching sessions were recorded and fidelity to the manual was checked by a trained therapist. Fidelity ranged from 89% to 100% across all dyads

  • Control group: 12 weeks of baseline (no intervention: phase 1) followed by wait‐list (12 weeks: phase 2). The control group were then offered the intervention for 12 weeks (phase 3), followed by 12 weeks of follow‐up (phase 4)

Outcomes Primary outcome:
  • Mean number of incidents of physical aggression and verbal aggression recorded by individuals and staff or home carers each week, during each 12‐week phase. This scale was developed for the study

  • Inter‐rater reliability between individuals and staff or home carers was assessed (agreements ranged from 92% to 100%)

Notes
  • Relevant data were extrapolated from graphs (bar charts with standard error bars)

  • 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; authors contacted but did not respond
Allocation concealment (selection bias) Unclear risk No information provided; authors contacted but did not respond
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding of participants and personnel
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Outcome assessments were completed by parents, support staff and individuals with intellectual disabilities, and therefore were not blinded to group allocation
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No incomplete data
Selective reporting (reporting bias) Low risk All prespecified 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