A Phase 3 interventional study of PBS based staff training and Treatment as Usual in Challenging Behaviour, sponsored by University College, London. Status unknown at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-23.
Sponsored by University College, London · Phase 3, Interventional, and Treatment
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.
Please see published protocol at:
http://www.biomedcentral.com/1471-244X/14/219
363 studies on the registry are indexed under Intellectual Disability; 103 are open to participants now.
This study's enrollment of 246 is above the median of 53 across 236 interventional studies indexed under Intellectual Disability.
Browse Intellectual Disability studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · 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
Please see published study protocol for more information: http://www.biomedcentral.com/1471-244X/14/219
http://www.biomedcentral.com/1471-244X/14/219
Challenging Behaviour
Reduction in challenging behaviour as measured by the Aberrant Behaviour Checklist (ABC)and change from baseline and 6 months
Time frame: 12 months
Quality of life
Improvement in Quality of Life measured by the Quality of Life Questionnaire
Time frame: 12 months
Mental health status
Improvement in mental health measured by the mini-PASADD.
Time frame: 12 months
Family carer burden
Reduction in family carer burden measured by the Uplift/Burden Scale
Time frame: 12 months
Paid carer burden
Reduction in burden measured by Caregiving Difficulty Scale-Intellectual Disability
Time frame: 12 months
Family Carer Psychiatric Morbidity
Reduction in Psychiatric morbidity measured by the General Health Questionnaire (12 item version)
Time frame: 12 months
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
Time frame: 12 months
Community participation
Improvement measured by change in Guernsey Community Participation and Leisure Activity Scale (GCPLAS)
Time frame: 6 months
Community participation
Positive change from 6 months as measured with the GCPLAS
Time frame: 12 months
This study is status unknown, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University College, London