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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by University College, London
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01680276
First received: August 28, 2012
Last updated: September 3, 2012
Last verified: September 2012

August 28, 2012
September 3, 2012
November 2012
August 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01680276 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
  • 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
Same as current
 
Clinical and Cost Effectiveness of Positive Behaviour Support: a Trial
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 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Treatment of Challenging Behaviour in Intellectual and Developmental Disability
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
260
November 2016
August 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Angela Hassiotis, MD PhD +442079743788 a.hassiotis@ucl.ac.uk
United Kingdom
 
NCT01680276
10/104/13
Yes
University College, London
University College, London
Not Provided
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
University College, London
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP