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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01680276
First received: August 28, 2012
Last updated: June 22, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Challenging Behaviour
Behavioral: PBS based staff training
Other: Treatment as Usual
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Other Outcome Measures:
  • 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


Enrollment: 246
Study Start Date: November 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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

Detailed Description:

Please see published protocol at:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680276

Locations
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, United Kingdom
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01680276     History of Changes
Other Study ID Numbers: 10/104/13
Study First Received: August 28, 2012
Last Updated: June 22, 2015
Health Authority: United Kingdom: National Institute for Health Research

Keywords provided by University College, London:
intellectual disability
developmental disability
challenging behaviour
behavioural intervention
training

Additional relevant MeSH terms:
Intellectual Disability
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 05, 2015