<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01680276</url>
  </required_header>
  <id_info>
    <org_study_id>10/104/13</org_study_id>
    <nct_id>NCT01680276</nct_id>
  </id_info>
  <brief_title>Clinical and Cost Effectiveness of Positive Behaviour Support: a Trial</brief_title>
  <acronym>PBS</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many people with intellectual disability have challenging behaviour which often has serious&#xD;
      consequences such as the prescription of long term medication, in-patient admissions and&#xD;
      disruption of normal daily activities. Community intellectual disability services may have&#xD;
      difficulties in helping people with challenging behavior. Available research suggests that&#xD;
      Positive Behavior Support (PBS), a training system that teaches staff how to manage these&#xD;
      situations, can benefit service users who may show improvements in challenging behavior and&#xD;
      quality of life. The investigators do not know of any study so far that has examined the&#xD;
      clinical and cost effectiveness of PBS that is provided by staff in routine clinical practice&#xD;
      in community intellectual disability services. If PBS proved to be better than treatment as&#xD;
      usual, it would have important implications for the management of a very vulnerable group of&#xD;
      service users. In this trial, health staff will receive accredited training in PBS available&#xD;
      in a manual written by PBS experts. It will give details of how to understand challenging&#xD;
      behavior and develop a management plan and how to implement it and monitor whether it has&#xD;
      achieved its goals. Twenty community intellectual disability services and 260 service users&#xD;
      with mild to severe intellectual disability and challenging behavior will be invited to take&#xD;
      part in the study. The sample size calculations are based on our pilot study and allow for&#xD;
      non participation of 10% and inflation due to the number of community intellectual disability&#xD;
      teams and staff that will take part. The teams will be randomly allocated into one of two&#xD;
      conditions. Half will be in the PBS arm (but will also have treatment as usual) and half will&#xD;
      be in the treatment as usual only group. The investigators will carry out assessments of&#xD;
      challenging behavior, use of services, quality of life, mental health, aggression and family&#xD;
      and paid carer burden at six and 12 months. The investigators will monitor treatment fidelity&#xD;
      and the investigators will talk to a sample of paid and family carers, service users, staff&#xD;
      and managers about what they think of the treatment and how best the investigators can&#xD;
      deliver it in routine care. The main outcome is reduction in challenging behavior at one year&#xD;
      after the randomization. The investigators will also carry out a health economic evaluation&#xD;
      to examine the costs and consequences of staff training in PBS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Please see published protocol at:&#xD;
&#xD;
      http://www.biomedcentral.com/1471-244X/14/219&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Challenging Behaviour</measure>
    <time_frame>12 months</time_frame>
    <description>Reduction in challenging behaviour as measured by the Aberrant Behaviour Checklist (ABC)and change from baseline and 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>12 months</time_frame>
    <description>Improvement in Quality of Life measured by the Quality of Life Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental health status</measure>
    <time_frame>12 months</time_frame>
    <description>Improvement in mental health measured by the mini-PASADD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family carer burden</measure>
    <time_frame>12 months</time_frame>
    <description>Reduction in family carer burden measured by the Uplift/Burden Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paid carer burden</measure>
    <time_frame>12 months</time_frame>
    <description>Reduction in burden measured by Caregiving Difficulty Scale-Intellectual Disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Carer Psychiatric Morbidity</measure>
    <time_frame>12 months</time_frame>
    <description>Reduction in Psychiatric morbidity measured by the General Health Questionnaire (12 item version)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cost effectiveness</measure>
    <time_frame>12 months</time_frame>
    <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</description>
  </other_outcome>
  <other_outcome>
    <measure>Community participation</measure>
    <time_frame>6 months</time_frame>
    <description>Improvement measured by change in Guernsey Community Participation and Leisure Activity Scale (GCPLAS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Community participation</measure>
    <time_frame>12 months</time_frame>
    <description>Positive change from 6 months as measured with the GCPLAS</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">246</enrollment>
  <condition>Challenging Behaviour</condition>
  <arm_group>
    <arm_group_label>PBS based staff training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The training, which will be supported by a treatment manual will comprise the following sections:&#xD;
Functional Behavioural Assessment and formulation skills&#xD;
• Brief Behavioural Assessment Tool for brief functional analyses&#xD;
Primary Prevention&#xD;
Secondary Prevention and Reactive Strategies&#xD;
Periodic Service Review and Problem Solving&#xD;
Developing individualised periodic service reviews&#xD;
Trouble shooting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PBS based staff training</intervention_name>
    <description>Please see published study protocol for more information:&#xD;
http://www.biomedcentral.com/1471-244X/14/219</description>
    <arm_group_label>PBS based staff training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <description>http://www.biomedcentral.com/1471-244X/14/219</description>
    <arm_group_label>PBS based staff training</arm_group_label>
    <arm_group_label>Treatment as usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Service users: Eligible to receive care from intellectual disability services; mild to&#xD;
             severe intellectual disability; aged 18 years and over; total ABC score of at least 15&#xD;
             (indicates a degree of challenging behaviour occurring at least weekly including&#xD;
             verbal or physical aggression, hyperactivity, refusal to attend activities, non&#xD;
             responsiveness that requires professional input).&#xD;
&#xD;
          -  Service: Willing to participate; availability of at least two staff members willing to&#xD;
             train; written agreement by the service manager to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Service users: primary clinical diagnosis of personality disorder or substance misuse;&#xD;
             relapse in pre-existing mental disorder; decision by clinical team that a referral to&#xD;
             the study would be inappropriate, e.g. there is an open complaint investigation&#xD;
&#xD;
          -  Service: there are no team members willing to train; the service has already received&#xD;
             and implements accredited PBS for their service users.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andre Strydom, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>UCL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ian Hall, MBBS MPhil</last_name>
    <role>Study Director</role>
    <affiliation>East London Foundation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael King, FRCGP PhD</last_name>
    <role>Study Director</role>
    <affiliation>UCL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rumana Omar</last_name>
    <role>Study Director</role>
    <affiliation>UCL Statistics</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rachael Hunter</last_name>
    <role>Study Director</role>
    <affiliation>Health Economist</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vivien Cooper</last_name>
    <role>Study Director</role>
    <affiliation>Challenging Behaviour Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Leicestershire Foundation Trust</name>
      <address>
        <city>Leicester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Camden &amp; Islington Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South London and St George's Mental Health Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.biomedcentral.com/1471-244X/14/219</url>
    <description>Published protocol in open access journal</description>
  </link>
  <reference>
    <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.</citation>
    <PMID>25927187</PMID>
  </reference>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>May 20, 2016</last_update_submitted>
  <last_update_submitted_qc>May 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intellectual disability</keyword>
  <keyword>developmental disability</keyword>
  <keyword>challenging behaviour</keyword>
  <keyword>behavioural intervention</keyword>
  <keyword>training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intellectual Disability</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01680276
org study id: 10/104/13
nct id: NCT01680276
lead sponsor: 
has dmc: Yes
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Challenging Behaviour
time frame: 12 months
description: Reduction in challenging behaviour as measured by the Aberrant Behaviour Checklist (ABC)and change from baseline and 6 months
measure: Quality of life
time frame: 12 months
description: Improvement in Quality of Life measured by the Quality of Life Questionnaire
measure: Mental health status
time frame: 12 months
description: Improvement in mental health measured by the mini-PASADD.
measure: Family carer burden
time frame: 12 months
description: Reduction in family carer burden measured by the Uplift/Burden Scale
measure: Paid carer burden
time frame: 12 months
description: Reduction in burden measured by Caregiving Difficulty Scale-Intellectual Disability
measure: Family Carer Psychiatric Morbidity
time frame: 12 months
description: Reduction in Psychiatric morbidity measured by the General Health Questionnaire (12 item version)
measure: Cost effectiveness
time frame: 12 months
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
measure: Community participation
time frame: 6 months
description: Improvement measured by change in Guernsey Community Participation and Leisure Activity Scale (GCPLAS)
measure: Community participation
time frame: 12 months
description: Positive change from 6 months as measured with the GCPLAS
arm group label: PBS based staff training
arm group type: Experimental
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 group label: Treatment as usual
arm group type: Other
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: PBS based staff training
description: Please see published study protocol for more information:
http://www.biomedcentral.com/1471-244X/14/219
arm group label: PBS based staff training
intervention type: Other
intervention name: Treatment as Usual
description: http://www.biomedcentral.com/1471-244X/14/219
arm group label: PBS based staff training
arm group label: Treatment as usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andre Strydom, MD PhD
role: Study Director
affiliation: UCL
last name: Ian Hall, MBBS MPhil
role: Study Director
affiliation: East London Foundation Trust
last name: Michael King, FRCGP PhD
role: Study Director
affiliation: UCL
last name: Rumana Omar
role: Study Director
affiliation: UCL Statistics
last name: Rachael Hunter
role: Study Director
affiliation: Health Economist
last name: Vivien Cooper
role: Study Director
affiliation: Challenging Behaviour Foundation
facility: 
facility: 
facility: 
country: United Kingdom
url: http://www.biomedcentral.com/1471-244X/14/219
description: Published protocol in open access journal
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.
PMID: 25927187
responsible party type: Sponsor
mesh term: Intellectual Disability