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Headline
Staff training in positive behaviour support did not reduce challenging behaviour in people with intellectual disability, although both service users and carers reported some benefits from the training.
Abstract
Background:
Preliminary studies have indicated that training staff in Positive Behaviour Support (PBS) may help to reduce challenging behaviour among people with intellectual disability (ID).
Objective:
To evaluate whether or not such training is clinically effective in reducing challenging behaviour in routine care. The study also included longer-term follow-up (approximately 36 months).
Design:
A multicentre, single-blind, two-arm, parallel-cluster randomised controlled trial. The unit of randomisation was the community ID service using an independent web-based randomisation system and random permuted blocks on a 1 : 1 allocation stratified by a staff-to-patient ratio for each cluster.
Setting:
Community ID services in England.
Participants:
Adults (aged > 18 years) across the range of ID with challenging behaviour [≥ 15 Aberrant Behaviour Checklist – Community total score (ABC-CT)].
Interventions:
Manual-assisted face-to-face PBS training to therapists and treatment as usual (TAU) compared with TAU only in the control arm.
Main outcome measures:
Carer-reported changes in challenging behaviour as measured by the ABC-CT over 12 months. Secondary outcomes included psychopathology, community participation, family and paid carer burden, family carer psychopathology, costs of care and quality-adjusted life-years (QALYs). Data on main outcome, service use and health-related quality of life were collected for the 36-month follow-up.
Results:
A total of 246 participants were recruited from 23 teams, of whom 109 were in the intervention arm (11 teams) and 137 were in the control arm (12 teams). The difference in ABC-CT between the intervention and control arms [mean difference –2.14, 95% confidence interval (CI) –8.79 to 4.51; p = 0.528] was not statistically significant. No treatment effects were found for any of the secondary outcomes. The mean cost per participant in the intervention arm was £1201. Over 12 months, there was a difference in QALYs of 0.076 in favour of the intervention (95% CI 0.011 to 0.140 QALYs) and a 60% chance that the intervention is cost-effective compared with TAU from a health and social care cost perspective at the threshold of £20,000 per QALY gained. Twenty-nine participants experienced 45 serious adverse events (intervention arm, n = 19; control arm, n = 26). PBS plans were available for 33 participants. An independent assessment of the quality of these plans found that all were less than optimal. Forty-six qualitative interviews were conducted with service users, family carers, paid carers and service managers as part of the process evaluation. Service users reported that they had learned to manage difficult situations and had gained new skills, and carers reported a positive relationship with therapists. At 36 months’ follow-up (n = 184), the mean ABC-CT difference between arms was not significant (–3.70, 95% CI –9.25 to 1.85; p = 0.191). The initial cost-effectiveness of the intervention dissipated over time.
Limitations:
The main limitations were low treatment fidelity and reach of the intervention.
Conclusions:
Findings from the main study and the naturalistic follow-up suggest that staff training in PBS as delivered in this study is insufficient to achieve significant clinical gains beyond TAU in community ID services. Although there is an indication that training in PBS is potentially cost-effective, this is not maintained in the longer term. There is increased scope to develop new approaches to challenging behaviour as well as optimising the delivery of PBS in routine clinical practice.
Trial registration:
This study is registered as NCT01680276.
Funding:
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 15. See the NIHR Journals Library website for further project information.
Contents
- Plain English summary
- Scientific summary
- Chapter 1. Background
- Chapter 2. Methods
- Trial design
- Sample size
- Service and participant recruitment
- Randomisation and masking
- Possible sources of bias
- Inclusion criteria
- Exclusion criteria
- Interventions
- Frequency and duration of follow-up
- Ethics issues, research governance and consent
- Serious adverse events
- Outcome measures and instruments
- Data entry
- Statistical analysis
- Blinding and unmasking
- Health economic evaluation
- Participants with autism
- Changes to study protocol
- Long-term follow-up
- Process evaluation
- Logic model
- Patient and public involvement
- Chapter 3. Results
- Participants
- Primary outcome
- Subgroup analysis
- Sensitivity analysis
- Exploratory multivariate analyses
- Secondary outcomes
- Subsample with autism spectrum disorders
- Serious adverse events
- Blinding and unmasking
- Health economic evaluation
- Long-term follow-up
- Process evaluation
- Mechanisms of impact: stakeholder interviews
- Chapter 4. Discussion
- Acknowledgements
- References
- Appendix 1. Positive Behaviour Support training outline
- Appendix 2. Research and development departments and corresponding sites in the participating NHS trusts
- Appendix 3. National Research Ethics Service serious adverse event form
- Appendix 4. Unit costs for health, social care and criminal justice
- Appendix 5. Resource use: main study
- Appendix 6. Aberrant Behaviour Checklist – Community subscales at 36 months
- Appendix 7. Resource use and societal costs: long-term follow-up
- Appendix 8. External assessment of plan quality
- Appendix 9. Topic guides for qualitative interviews
- Appendix 10. Client Service Receipt Inventory modified for the Positive Behaviour Support study
- List of abbreviations
About the Series
Article history
The research reported in this issue of the journal was funded by the HTA programme as project number 10/104/13. The contractual start date was in November 2012. The draft report began editorial review in May 2017 and was accepted for publication in October 2017. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
Declared competing interests of authors
Rumana Omar reports membership of the Health Technology Assessment General Board. Michael King is a member of the PRIMENT Clinical Trials Unit, which is funded by the National Institute for Health Research.
Last reviewed: May 2017; Accepted: October 2017.
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