Clinical and Cost Effectiveness of Positive Behaviour Support: a Trial

Challenging Behaviour Clinical Trial

— PBS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01680276
• Other study ID #: 10/104/13
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 28, 2012
• Last updated: May 20, 2016
• Start date: November 2012
• Est. completion date: November 2016

Study information

• Verified date: June 2015
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Please see published protocol at:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 246
• Est. completion date: November 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Challenging Behaviour
• Intellectual Disability

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Leicestershire Foundation Trust	Leicester
United Kingdom	Camden & Islington Foundation Trust	London
United Kingdom	South London and St George's Mental Health Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Community participation	Improvement measured by change in Guernsey Community Participation and Leisure Activity Scale (GCPLAS)	6 months	No
Other	Community participation	Positive change from 6 months as measured with the GCPLAS	12 months	No
Primary	Challenging Behaviour	Reduction in challenging behaviour as measured by the Aberrant Behaviour Checklist (ABC)and change from baseline and 6 months	12 months	No
Secondary	Quality of life	Improvement in Quality of Life measured by the Quality of Life Questionnaire	12 months	No
Secondary	Mental health status	Improvement in mental health measured by the mini-PASADD.	12 months	No
Secondary	Family carer burden	Reduction in family carer burden measured by the Uplift/Burden Scale	12 months	No
Secondary	Paid carer burden	Reduction in burden measured by Caregiving Difficulty Scale—Intellectual Disability	12 months	No
Secondary	Family Carer Psychiatric Morbidity	Reduction in Psychiatric morbidity measured by the General Health Questionnaire (12 item version)	12 months	No

External Links

•   Published protocol in open access journal