Citation

Griffith GM, Jones R, Hastings RP, Crane RS, Roberts J, Williams J, Bryning L, Hoare Z, Edwards RT. Pilot Feasibility Stud. 2016; 2: e58.

Affiliation

Centre for Health Economics and Medicines Evaluation (CHEME), Bangor University, Bangor, UK.

Copyright

(Copyright © 2016, Holtzbrinck Springer Nature Publishing Group - BMC)

DOI

10.1186/s40814-016-0098-3

PMID

27965874

PMCID

PMC5154058

Abstract

BACKGROUND: Approximately 10-20 % of adults with intellectual disabilities engage in challenging behaviours such as aggression, destructiveness, and self-injury, which are often accompanied by feelings of anger. The inability to manage anger can reduce quality of life. For example, aggression is a strong predictor of out-of-area placements and is a risk variable for abuse. Recent research suggests that mindfulness-based therapies (specifically, Singh's Soles of the Feet meditation) can help people with intellectual disabilities manage angry emotions, with resultant reductions in challenging behaviour. However, previous research has been single-case design studies, and no group studies have been published with people with intellectual disabilities and aggressive behaviour.

METHODS/DESIGN: For this feasibility study, a UK protocol will be developed for use by health professionals within National Health Service (NHS) Intellectual Disability (ID) teams, based upon Singh's Soles of the Feet manual. Twenty adults with intellectual disabilities and identified problems with anger control will be recruited and six sessions will be delivered by a trained ID clinician. The study will monitor participant's aggressive behaviour, health-related quality of life, anxiety, depression, and use of support services (medication, hospital appointments etc.). These will be measured at three time points: (1) Baseline (within 2 weeks prior to the first session of the intervention), (2) 2 months post-baseline, and (3) 6 months post-baseline. Qualitative interviews will be conducted with participants, their carers, and the therapists who delivered the intervention. In order to help design an economic evaluation alongside a future full trial, we will cost the intervention and test the acceptability and validity of health economics measures to record resource use and health-related quality of life outcomes.

DISCUSSION: The data from this study will inform the feasibility of the project protocol and intervention, which will help develop future research and to determine whether a larger, randomised controlled trial with concurrent economic evaluation is feasible. TRIAL REGISTRATION: UKCERN: 16743.

Language: en