Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Many people with intellectual disability have challenging behaviour which often has serious consequences such as the prescription of long term medication, in-patient admissions and disruption of normal daily activities. Community intellectual disability services may have difficulties in helping people with challenging behavior. Available research suggests that Positive Behavior Support (PBS), a training system that teaches staff how to manage these situations, can benefit service users who may show improvements in challenging behavior and quality of life. The investigators do not know of any study so far that has examined the clinical and cost effectiveness of PBS that is provided by staff in routine clinical practice in community intellectual disability services. If PBS proved to be better than treatment as usual, it would have important implications for the management of a very vulnerable group of service users. In this trial, health staff will receive accredited training in PBS available in a manual written by PBS experts. It will give details of how to understand challenging behavior and develop a management plan and how to implement it and monitor whether it has achieved its goals. Twenty community intellectual disability services and 260 service users with mild to severe intellectual disability and challenging behavior will be invited to take part in the study. The sample size calculations are based on our pilot study and allow for non participation of 10% and inflation due to the number of community intellectual disability teams and staff that will take part. The teams will be randomly allocated into one of two conditions. Half will be in the PBS arm (but will also have treatment as usual) and half will be in the treatment as usual only group. The investigators will carry out assessments of challenging behavior, use of services, quality of life, mental health, aggression and family and paid carer burden at six and 12 months. The investigators will monitor treatment fidelity and the investigators will talk to a sample of paid and family carers, service users, staff and managers about what they think of the treatment and how best the investigators can deliver it in routine care. The main outcome is reduction in challenging behavior at one year after the randomization. The investigators will also carry out a health economic evaluation to examine the costs and consequences of staff training in PBS.
Please see published protocol at:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBS based staff training | Experimental | The training, which will be supported by a treatment manual will comprise the following sections:
|
|
| Treatment as usual | Other | Most community intellectual disability services provide a range of health interventions that include but are not limited to psychiatric assessment and management, nursing support, psychology, speech and language therapy, occupational therapy and counselling. There may be some variation in resources but service users with challenging behaviour are likely to receive a range of broadly defined behavioural management and pharmacological interventions. Staff is routinely supervised by their clinical managers weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBS based staff training | Behavioral | Please see published study protocol for more information: |
|
| Measure | Description | Time Frame |
|---|---|---|
| Challenging Behaviour | Reduction in challenging behaviour as measured by the Aberrant Behaviour Checklist (ABC)and change from baseline and 6 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Improvement in Quality of Life measured by the Quality of Life Questionnaire | 12 months |
| Mental health status | Improvement in mental health measured by the mini-PASADD. |
| Measure | Description | Time Frame |
|---|---|---|
| Cost effectiveness | Service use will be measured over the trial period at three month intervals using the Client Service Receipt Inventory adapted specifically for the study | 12 months |
| Community participation |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andre Strydom, MD PhD | UCL | Study Director |
| Ian Hall, MBBS MPhil | East London Foundation Trust | Study Director |
| Michael King, FRCGP PhD | UCL | Study Director |
| Rumana Omar | UCL Statistics | Study Director |
| Rachael Hunter | Health Economist | Study Director |
| Vivien Cooper | Challenging Behaviour Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leicestershire Foundation Trust | Leicester | United Kingdom | ||||
| Camden & Islington Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25927187 | Background | Hassiotis A, Strydom A, Crawford M, Hall I, Omar R, Vickerstaff V, Hunter R, Crabtree J, Cooper V, Biswas A, Howie W, King M. Clinical and cost effectiveness of staff training in Positive Behaviour Support (PBS) for treating challenging behaviour in adults with intellectual disability: a cluster randomised controlled trial. BMC Psychiatry. 2014 Aug 3;14:219. doi: 10.1186/s12888-014-0219-6. | |
| 32293383 |
| Label | URL |
|---|---|
| Published protocol in open access journal | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D002658 | Developmental Disabilities |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Treatment as Usual | Other |
|
| 12 months |
| Family carer burden | Reduction in family carer burden measured by the Uplift/Burden Scale | 12 months |
| Paid carer burden | Reduction in burden measured by Caregiving Difficulty Scale-Intellectual Disability | 12 months |
| Family Carer Psychiatric Morbidity | Reduction in Psychiatric morbidity measured by the General Health Questionnaire (12 item version) | 12 months |
Improvement measured by change in Guernsey Community Participation and Leisure Activity Scale (GCPLAS)
| 6 months |
| Community participation | Positive change from 6 months as measured with the GCPLAS | 12 months |
| London |
| United Kingdom |
| South London and St George's Mental Health Trust | London | United Kingdom |
| Derived |
| Strydom A, Bosco A, Vickerstaff V, Hunter R; PBS study group; Hassiotis A. Clinical and cost effectiveness of staff training in the delivery of Positive Behaviour Support (PBS) for adults with intellectual disabilities, autism spectrum disorder and challenging behaviour - randomised trial. BMC Psychiatry. 2020 Apr 15;20(1):161. doi: 10.1186/s12888-020-02577-1. |
| 32019635 | Derived | Hunter RM, Vickerstaff V, Poppe M, Strydom A, King M, Hall I, Crabtree J, Omar R, Cooper V, Biswas A, Hassiotis A. Staff training in positive behaviour support for behaviour that challenges in people with intellectual disability: cost-utility analysis of a cluster randomised controlled trial. BJPsych Open. 2020 Feb 5;6(2):e15. doi: 10.1192/bjo.2020.1. |
| 29596045 | Derived | Hassiotis A, Poppe M, Strydom A, Vickerstaff V, Hall I, Crabtree J, Omar R, King M, Hunter R, Bosco A, Biswas A, Ratti V, Blickwedel J, Cooper V, Howie W, Crawford M. Positive behaviour support training for staff for treating challenging behaviour in people with intellectual disabilities: a cluster RCT. Health Technol Assess. 2018 Mar;22(15):1-110. doi: 10.3310/hta22150. |
| 29436314 | Derived | Hassiotis A, Poppe M, Strydom A, Vickerstaff V, Hall IS, Crabtree J, Omar RZ, King M, Hunter R, Biswas A, Cooper V, Howie W, Crawford MJ. Clinical outcomes of staff training in positive behaviour support to reduce challenging behaviour in adults with intellectual disability: cluster randomised controlled trial. Br J Psychiatry. 2018 Mar;212(3):161-168. doi: 10.1192/bjp.2017.34. Epub 2018 Feb 12. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |