Clinical and Cost Effectiveness of Positive Behaviour Support: a Trial (PBS community)

• Challenging Behaviour [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Reduction in challenging behaviour as measured by the Aberrant Behaviour Checklist (ABC)and change from baseline and 6 months
• Challenging Behaviour [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Reduction in challenging behaviour as measured by the Aberrant Behaviour Checklist

• Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Improvement in Quality of Life measured by the Quality of Life Questionnaire
• Mental health status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Improvement in mental health measured by the mini-PASADD.
• Family carer burden [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Reduction in family carer burden measured by the Uplift/Burden Scale
• Paid carer burden [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Reduction in burden measured by Caregiving Difficulty Scale—Intellectual Disability
• Family Carer Psychiatric Morbidity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Reduction in Psychiatric morbidity measured by the General Health Questionnaire (12 item version)

• Cost effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Service use will be measured over the trial period at three month intervals using the Client Service Receipt Inventory adapted specifically for the study
• Community participation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Improvement measured by change in Guernsey Community Participation and Leisure Activity Scale (GCPLAS)
• Community participation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Positive change from 6 months as measured with the GCPLAS

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 behaviour. Available research suggests that Positive Behaviour Support (PBS), a training system that teaches staff how to manage these situations, can benefit service users who may show improvements in challenging behaviour and quality of life. Previous researchers have published small studies on its effectiveness but these studies have methodological problems. 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 experts in PBS. It will give details of how to understand challenging behaviour 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 behaviour 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 behaviour, 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 behaviour at one year after the randomisation. The investigators will also carry out a health economic evaluation to examine the costs and consequences of staff training in PBS. The study will last for four years and the investigators will run it in community intellectual disability services in England. The investigators will follow the research and clinical governance guidance and seek ethical approval before the study starts.

• Behavioral: PBS based staff training
• Other: Treatment as Usual

• Experimental: PBS based staff training

  The training, which will be supported by a treatment manual will comprise the following sections:

  1. Functional Behavioural Assessment and formulation skills

     • Brief Behavioural Assessment Tool for brief functional analyses

  2. Primary Prevention
  3. Secondary Prevention and Reactive Strategies

  4. Periodic Service Review and Problem Solving

     • Developing individualised periodic service reviews
     • Trouble shooting
  Intervention: Behavioral: PBS based staff training
• Treatment as usual
  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.
  Intervention: Other: Treatment as Usual

Inclusion Criteria:

• Service users: Eligible to receive care from intellectual disability services; mild to severe intellectual disability; aged 18 years and over; total ABC score of at least 15 (indicates a degree of challenging behaviour occurring at least weekly including verbal or physical aggression, hyperactivity, refusal to attend activities, non responsiveness that requires professional input).
• Service: Willing to participate; availability of at least two staff members willing to train; written agreement by the service manager to participate.

Exclusion Criteria:

• Service users: primary clinical diagnosis of personality disorder or substance misuse; relapse in pre-existing mental disorder; decision by clinical team that a referral to the study would be inappropriate, e.g. there is an open complaint investigation
• Service: there are no team members willing to train; the service has already received and implements accredited PBS for their service users.