<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/NCT02211339</url>
  </required_header>
  <id_info>
    <org_study_id>UCL JRO ref: 13/0477</org_study_id>
    <secondary_id>14/SC/0048</secondary_id>
    <nct_id>NCT02211339</nct_id>
  </id_info>
  <brief_title>A New Intervention for Social Communication Skills Following Brain Injury</brief_title>
  <official_title>An Investigation Into the Effectiveness of a Social Communication Skills Training Programme for Adults Following Brain Injury Using a Peer Learning Model</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the effectiveness of a peer-led social skills training intervention compared&#xD;
      to social activity (usual care) to improve social communication skills following severe brain&#xD;
      injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A pilot study first tested the feasibility of the approach and the sensitivity of existing&#xD;
      outcome measures to changes in group social interaction. Following amendments to the pilot&#xD;
      protocol, twelve new participants with severe ABI were recruited from a residential&#xD;
      post-acute rehabilitation centre in April 2015. An experimental parallel group design was&#xD;
      used to compare a peer-led group intervention to a staff-led social activity group.&#xD;
      Participants were randomised to a peer-led intervention (n=6) or a staff-led social activity&#xD;
      group (usual care) (n=6). The groups met twice a week for 8 weeks. A peer with severe ABI was&#xD;
      trained separately to facilitate interaction in the peer-led group. The training took place&#xD;
      in 16 individual sessions over 4 weeks. Group behaviour was measured twice at baseline, after&#xD;
      intervention and at maintenance (4 weeks) using measures meeting reliability, validity and&#xD;
      responsiveness criteria tested in the pilot study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>An experimental parallel group design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Adapted Measure of Participation in Conversation (MPC): Interaction Scale</measure>
    <time_frame>Baseline to maintenance (week 12)</time_frame>
    <description>This 9 point Likert scale is a measure of verbal and non-verbal participation in conversation. Scores range from 0 (no participation) to 4 (full participation) with half point scoring.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Adapted Measure of Participation in Conversation (MPC): Transaction Scale</measure>
    <time_frame>Baseline to maintenance (week 12)</time_frame>
    <description>This 9 point Likert scale is a measure of the ability to share and request information in conversation. Scores range from 0 (no participation) to 4 (full participation) with half point scoring.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Interactional Network Tool (INT)</measure>
    <time_frame>Baseline to maintenance (week 12)</time_frame>
    <description>A new measure of group social participation developed for this study. The INT captures group interaction patterns using communication behaviour frequencies and principles of social network analysis. The data is relational and follows a scale-free distribution.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>La Trobe Communication Questionnaire (LCQ) (self-report)</measure>
    <time_frame>Baseline to maintenance (week 12)</time_frame>
    <description>A 30 item self-report questionnaire measuring perceived change in social communication skills. Response options are entered on a four point Likert scale (range: 30-120 with a higher score indicating more impaired skills).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>La Trobe Communication Questionnaire (LCQ) (other-report)</measure>
    <time_frame>Baseline to maintenance (week 12)</time_frame>
    <description>A 30 item questionnaire measuring perceived change in social communication skills, rated by a familiar communication partner. Response options are entered on a four point Likert scale (range: 30-120 with a higher score indicating more impaired skills).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Brain Injuries</condition>
  <arm_group>
    <arm_group_label>Peer-led intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals met twice a week for 8 weeks and participated in a peer-mediated social communication skills group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Staff-led social activity group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals met twice a week for 8 weeks and participated in staff-led social activities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer facilitator training</intervention_name>
    <description>Peer facilitation of a project-based activity without staff present</description>
    <arm_group_label>Peer-led intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Staff-led social activity</description>
    <arm_group_label>Staff-led social activity group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults between 18 and 70 years&#xD;
&#xD;
          -  A diagnosis of severe traumatic brain injury (TBI) or severe acquired brain injury&#xD;
             (ABI) with similar cognitive presentation to TBI&#xD;
&#xD;
          -  Minimum of six months post injury&#xD;
&#xD;
          -  Evidence of a social communication impairment as a result of injury&#xD;
&#xD;
          -  Ability to tolerate group activity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant aphasia&#xD;
&#xD;
          -  Severe depression or psychiatric disorder&#xD;
&#xD;
          -  Insufficient English to converse with peers&#xD;
&#xD;
          -  Profound cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzanne Beeke, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College, London</affiliation>
  </overall_official>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>October 10, 2019</last_update_submitted>
  <last_update_submitted_qc>October 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Social skills</keyword>
  <keyword>Social communication</keyword>
  <keyword>Cognitive communication</keyword>
  <keyword>Traumatic brain injury</keyword>
  <keyword>Acquired brain injury</keyword>
  <keyword>Communication partner training</keyword>
  <keyword>Peer partner training</keyword>
  <keyword>Peer mentoring</keyword>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Available on request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Starting after publication (2019)</ipd_time_frame>
    <ipd_access_criteria>University College London open access repository</ipd_access_criteria>
    <ipd_url>http://discovery.ucl.ac.uk</ipd_url>
  </patient_data>
  <!-- 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/NCT02211339
org study id: UCL JRO ref: 13/0477
secondary id: 14/SC/0048
nct id: NCT02211339
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To investigate the effectiveness of a peer-led social skills training intervention compared
      to social activity (usual care) to improve social communication skills following severe brain
      injury.
A pilot study first tested the feasibility of the approach and the sensitivity of existing
      outcome measures to changes in group social interaction. Following amendments to the pilot
      protocol, twelve new participants with severe ABI were recruited from a residential
      post-acute rehabilitation centre in April 2015. An experimental parallel group design was
      used to compare a peer-led group intervention to a staff-led social activity group.
      Participants were randomised to a peer-led intervention (n=6) or a staff-led social activity
      group (usual care) (n=6). The groups met twice a week for 8 weeks. A peer with severe ABI was
      trained separately to facilitate interaction in the peer-led group. The training took place
      in 16 individual sessions over 4 weeks. Group behaviour was measured twice at baseline, after
      intervention and at maintenance (4 weeks) using measures meeting reliability, validity and
      responsiveness criteria tested in the pilot study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: An experimental parallel group design
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The Adapted Measure of Participation in Conversation (MPC): Interaction Scale
time frame: Baseline to maintenance (week 12)
description: This 9 point Likert scale is a measure of verbal and non-verbal participation in conversation. Scores range from 0 (no participation) to 4 (full participation) with half point scoring.
measure: The Adapted Measure of Participation in Conversation (MPC): Transaction Scale
time frame: Baseline to maintenance (week 12)
description: This 9 point Likert scale is a measure of the ability to share and request information in conversation. Scores range from 0 (no participation) to 4 (full participation) with half point scoring.
measure: The Interactional Network Tool (INT)
time frame: Baseline to maintenance (week 12)
description: A new measure of group social participation developed for this study. The INT captures group interaction patterns using communication behaviour frequencies and principles of social network analysis. The data is relational and follows a scale-free distribution.
measure: La Trobe Communication Questionnaire (LCQ) (self-report)
time frame: Baseline to maintenance (week 12)
description: A 30 item self-report questionnaire measuring perceived change in social communication skills. Response options are entered on a four point Likert scale (range: 30-120 with a higher score indicating more impaired skills).
measure: La Trobe Communication Questionnaire (LCQ) (other-report)
time frame: Baseline to maintenance (week 12)
description: A 30 item questionnaire measuring perceived change in social communication skills, rated by a familiar communication partner. Response options are entered on a four point Likert scale (range: 30-120 with a higher score indicating more impaired skills).
arm group label: Peer-led intervention group
arm group type: Experimental
description: Individuals met twice a week for 8 weeks and participated in a peer-mediated social communication skills group.
arm group label: Staff-led social activity group
arm group type: Active Comparator
description: Individuals met twice a week for 8 weeks and participated in staff-led social activities.
intervention type: Behavioral
intervention name: Peer facilitator training
description: Peer facilitation of a project-based activity without staff present
arm group label: Peer-led intervention group
intervention type: Other
intervention name: Usual care
description: Staff-led social activity
arm group label: Staff-led social activity group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Suzanne Beeke, PhD
role: Principal Investigator
affiliation: University College, London
country: United Kingdom
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Wounds and Injuries
sharing ipd: Yes
ipd description: Available on request
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Starting after publication (2019)
ipd access criteria: University College London open access repository
ipd url: http://discovery.ucl.ac.uk