Challenging BehaviourPhase 3PBSNCT01680276
Clinical and Cost Effectiveness of Positive Behaviour Support: a Trial
A Phase 3 study testing PBS based staff training and Treatment as Usual in people with Challenging Behaviour, run by University College, London at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Challenging Behaviour
- What is being tested?
- PBS based staff training and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Nov 2012to Nov 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Leicestershire Foundation Trust
Leicester
Camden & Islington Foundation Trust
London
South London and St George's Mental Health Trust
London
About this study
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
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.
Read the detailed description
Please see published protocol at:
http://www.biomedcentral.com/1471-244X/14/219
- Conditions
- Challenging Behaviour
- Being tested
- PBS based staff training, Treatment as Usual
- Keywords
- intellectual disability, developmental disability, challenging behaviour, behavioural intervention, training
- Medical subject headings
- Intellectual Disability, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBS based staff trainingBehavioural
Please see published study protocol for more information:
http://www.biomedcentral.com/1471-244X/14/219
Treatment as UsualOther
http://www.biomedcentral.com/1471-244X/14/219
| Study group | Role | What they receive |
|---|---|---|
| PBS based staff training | Experimental | 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 Receives: Behavioral: PBS based staff training; Other: Treatment as Usual |
| Treatment as usual | Other | 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. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Challenging Behaviour
Reduction in challenging behaviour as measured by the Aberrant Behaviour Checklist (ABC)and change from baseline and 6 months
Measured: 12 months
Secondary outcomes (5)
Quality of life
Improvement in Quality of Life measured by the Quality of Life Questionnaire
Measured: 12 months
Mental health status
Improvement in mental health measured by the mini-PASADD.
Measured: 12 months
Family carer burden
Reduction in family carer burden measured by the Uplift/Burden Scale
Measured: 12 months
Paid carer burden
Reduction in burden measured by Caregiving Difficulty Scale-Intellectual Disability
Measured: 12 months
Family Carer Psychiatric Morbidity
Reduction in Psychiatric morbidity measured by the General Health Questionnaire (12 item version)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2015
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Challenging BehaviourStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andre Strydom, MD PhD, Study director, UCLIan Hall, MBBS MPhil, Study director, East London Foundation TrustMichael King, FRCGP PhD, Study director, UCLRumana Omar, Study director, UCL StatisticsRachael Hunter, Study director, Health EconomistVivien Cooper, Study director, Challenging Behaviour Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680276
- Sponsor's protocol ID
- 10/104/13
- Acronym
- PBS
- Status last verified
- Jun 2015
- First submitted
- 28 Aug 2012
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25927187Strydom 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.
PubMed 32293383Hunter 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.
PubMed 32019635Hassiotis 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.
PubMed 29596045Hassiotis 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.
PubMed 29436314
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01680276
- Acronym / sponsor ID
- PBS / 10/104/13
- Conditions
- Challenging Behaviour
- Keywords
- intellectual disability, developmental disability, challenging behaviour, behavioural intervention, training
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2016 (estimated)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBS based staff training | Experimental | Behavioral: PBS based staff training, Other: Treatment as UsualThe 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 |
| Treatment as usual | Other | Other: Treatment as UsualMost 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBS based staff trainingPlease see published study protocol for more information: http://www.biomedcentral.com/1471-244X/14/219 | Behavioural | PBS based staff training |
| Treatment as Usualhttp://www.biomedcentral.com/1471-244X/14/219 | Other | PBS based staff training, Treatment as usual |
Primary outcome
Challenging Behaviour
Time frame: 12 months
Reduction in challenging behaviour as measured by the Aberrant Behaviour Checklist (ABC)and change from baseline and 6 months
5 secondary outcomes
Quality of life
Time frame: 12 months
Mental health status
Time frame: 12 months
Family carer burden
Time frame: 12 months
Paid carer burden
Time frame: 12 months
Family Carer Psychiatric Morbidity
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Background: PubMed 25927187Hassiotis 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.
- Derived from this study: PubMed 32293383Strydom 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.
- Derived from this study: PubMed 32019635Hunter 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.
- Derived from this study: PubMed 29596045Hassiotis 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.
- Derived from this study: PubMed 29436314Hassiotis 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.
- Published protocol in open access journalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre Strydom, MD PhD study director
UCL
Ian Hall, MBBS MPhil study director
East London Foundation Trust
Michael King, FRCGP PhD study director
UCL
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PBS based staff training and Treatment as Usual in people with Challenging Behaviour, run by University College, London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Challenging Behaviour (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01680276, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.