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

Primary Purpose

Challenging Behaviour

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
PBS based staff training
Treatment as Usual
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Challenging Behaviour focused on measuring intellectual disability, developmental disability, challenging behaviour, behavioural intervention, training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PBS based staff training

Treatment as usual

Arm Description

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 Solving Developing individualised periodic service reviews Trouble shooting

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.

Outcomes

Primary Outcome Measures

Challenging Behaviour
Reduction in challenging behaviour as measured by the Aberrant Behaviour Checklist (ABC)and change from baseline and 6 months

Secondary Outcome Measures

Quality of life
Improvement in Quality of Life measured by the Quality of Life Questionnaire
Mental health status
Improvement in mental health measured by the mini-PASADD.
Family carer burden
Reduction in family carer burden measured by the Uplift/Burden Scale
Paid carer burden
Reduction in burden measured by Caregiving Difficulty Scale-Intellectual Disability
Family Carer Psychiatric Morbidity
Reduction in Psychiatric morbidity measured by the General Health Questionnaire (12 item version)

Full Information

First Posted
August 28, 2012
Last Updated
May 20, 2016
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT01680276
Brief Title
Clinical and Cost Effectiveness of Positive Behaviour Support: a Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Please see published protocol at: http://www.biomedcentral.com/1471-244X/14/219

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Challenging Behaviour
Keywords
intellectual disability, developmental disability, challenging behaviour, behavioural intervention, training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PBS based staff training
Arm Type
Experimental
Arm Description
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 Solving Developing individualised periodic service reviews Trouble shooting
Arm Title
Treatment as usual
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
PBS based staff training
Intervention Description
Please see published study protocol for more information: http://www.biomedcentral.com/1471-244X/14/219
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
http://www.biomedcentral.com/1471-244X/14/219
Primary Outcome Measure Information:
Title
Challenging Behaviour
Description
Reduction in challenging behaviour as measured by the Aberrant Behaviour Checklist (ABC)and change from baseline and 6 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
Improvement in Quality of Life measured by the Quality of Life Questionnaire
Time Frame
12 months
Title
Mental health status
Description
Improvement in mental health measured by the mini-PASADD.
Time Frame
12 months
Title
Family carer burden
Description
Reduction in family carer burden measured by the Uplift/Burden Scale
Time Frame
12 months
Title
Paid carer burden
Description
Reduction in burden measured by Caregiving Difficulty Scale-Intellectual Disability
Time Frame
12 months
Title
Family Carer Psychiatric Morbidity
Description
Reduction in Psychiatric morbidity measured by the General Health Questionnaire (12 item version)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Cost effectiveness
Description
Service use will be measured over the trial period at three month intervals using the Client Service Receipt Inventory adapted specifically for the study
Time Frame
12 months
Title
Community participation
Description
Improvement measured by change in Guernsey Community Participation and Leisure Activity Scale (GCPLAS)
Time Frame
6 months
Title
Community participation
Description
Positive change from 6 months as measured with the GCPLAS
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre Strydom, MD PhD
Organizational Affiliation
UCL
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ian Hall, MBBS MPhil
Organizational Affiliation
East London Foundation Trust
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael King, FRCGP PhD
Organizational Affiliation
UCL
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rumana Omar
Organizational Affiliation
UCL Statistics
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rachael Hunter
Organizational Affiliation
Health Economist
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vivien Cooper
Organizational Affiliation
Challenging Behaviour Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Leicestershire Foundation Trust
City
Leicester
Country
United Kingdom
Facility Name
Camden & Islington Foundation Trust
City
London
Country
United Kingdom
Facility Name
South London and St George's Mental Health Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25927187
Citation
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.
Results Reference
background
PubMed Identifier
32293383
Citation
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.
Results Reference
derived
PubMed Identifier
32019635
Citation
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.
Results Reference
derived
PubMed Identifier
29596045
Citation
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.
Results Reference
derived
PubMed Identifier
29436314
Citation
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.
Results Reference
derived
Links:
URL
http://www.biomedcentral.com/1471-244X/14/219
Description
Published protocol in open access journal

Learn more about this trial

Clinical and Cost Effectiveness of Positive Behaviour Support: a Trial

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