Methods |
Randomised controlled trial
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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)
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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
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Outcomes |
Primary outcome:
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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
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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 |