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

Clinical and Cost Effectiveness of Staff Training in Positive Behaviour Support (PBS) for Treating Challenging Behaviour in People With Intellectual Disability: A Cluster Randomised Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Challenging Behaviour
• Intervention / Treatment: Behavioral: PBS based staff training; Other: Treatment as Usual

Detailed Description

Please see published protocol at:

http://www.biomedcentral.com/1471-244X/14/219

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom
    • Leicestershire Foundation Trust
  • London, United Kingdom
    • Camden & Islington Foundation Trust
  • London, United Kingdom
    • South London and St George's Mental Health Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PBS based staff training; The training, which will be supported by a treatment manual will comprise the following sections: Functional Behavioural Assessment and formulation skills• Brief Behavioural Assessment Tool for brief functional analyses; Primary Prevention; Secondary Prevention and Reactive Strategies; Periodic Service Review and Problem SolvingDeveloping individualised periodic service reviewsTrouble shooting	Behavioral: PBS based staff training; Please see published study protocol for more information: http://www.biomedcentral.com/1471-244X/14/219; Other: Treatment as Usual; http://www.biomedcentral.com/1471-244X/14/219
OTHER: 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.	Other: Treatment as Usual; http://www.biomedcentral.com/1471-244X/14/219

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Study Director: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Published protocol in open access journal

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ANTICIPATED): November 1, 2016

Study Registration Dates

• First Submitted: August 28, 2012
• First Submitted That Met QC Criteria: September 3, 2012
• First Posted (ESTIMATE): September 7, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 23, 2016
• Last Update Submitted That Met QC Criteria: May 20, 2016
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: training; developmental disability; intellectual disability; behavioural intervention; challenging behaviour
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Intellectual Disability
• Other Study ID Numbers: 10/104/13