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Peer Intervention for Social Skills (Brain Injury)

Primary Purpose

Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Peer facilitator training
Usual care
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of severe traumatic brain injury (TBI) or severe ABI with similar cognitive presentation to TBI
  • Minimum of 6 months post injury
  • Evidence of social communication impairment as a result of injury
  • Ability to tolerate group activity

Exclusion Criteria:

  • Significant aphasia
  • Severe depression or psychiatric disorder
  • Insufficient English to converse with peer
  • Profound cognitive impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Peer-led intervention

    Staff-led social activity group

    Arm Description

    Individuals met twice a week for 8 weeks and participated in a peer-mediated social communication skills group.

    Individuals met twice a week for 8 weeks and participated in staff-led social activities.

    Outcomes

    Primary Outcome Measures

    The Adapted Measure of Participation in Conversation (MPC): Interaction Scale
    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.
    The Adapted Measure of Participation in Conversation (MPC): Transaction Scale
    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.
    The Interactional Network Tool (INT)
    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.

    Secondary Outcome Measures

    La Trobe Communication Questionnaire (self-report)
    The LCQ (self) is a measure of perceived change in social communication skills. Scores range from 30 - 120. A higher score indicates perception of more impaired skills.
    La Trobe Communication Questionnaire (other-report)
    The LCQ (other) is a measure of perceived change in social communication skills. Scores range from 30-120. A higher score indicates perception of more impaired skills.

    Full Information

    First Posted
    June 24, 2019
    Last Updated
    July 10, 2019
    Sponsor
    University College, London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03998124
    Brief Title
    Peer Intervention for Social Skills (Brain Injury)
    Official Title
    A Peer-led Intervention for Social Communication Skills Following Brain Injury (Main Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (Actual)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University College, London

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To investigate the effectiveness of a peer-led group intervention compared to a staff-led activity group to improve social communication skills for people with severe acquired brain injury (ABI).
    Detailed Description
    An earlier pilot study tested the feasibility of the approach and the sensitivity of existing outcome measures to changes in group social interaction (NCT02211339). Following amendments to the pilot study protocol, twelve new participants with severe ABI were recruited from a residential post-acute rehabilitation centre. 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    An experimental parallel group design
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Peer-led intervention
    Arm Type
    Experimental
    Arm Description
    Individuals met twice a week for 8 weeks and participated in a peer-mediated social communication skills group.
    Arm Title
    Staff-led social activity group
    Arm Type
    Active Comparator
    Arm Description
    Individuals met twice a week for 8 weeks and participated in staff-led social activities.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Peer facilitator training
    Intervention Description
    Peer facilitation of a project-based activity without staff present
    Intervention Type
    Other
    Intervention Name(s)
    Usual care
    Intervention Description
    Staff-led social activity
    Primary Outcome Measure Information:
    Title
    The Adapted Measure of Participation in Conversation (MPC): Interaction Scale
    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.
    Time Frame
    Baseline to maintenance (week 12)
    Title
    The Adapted Measure of Participation in Conversation (MPC): Transaction Scale
    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.
    Time Frame
    Baseline to maintenance (week 12)
    Title
    The Interactional Network Tool (INT)
    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.
    Time Frame
    Baseline to maintenance (week 12)
    Secondary Outcome Measure Information:
    Title
    La Trobe Communication Questionnaire (self-report)
    Description
    The LCQ (self) is a measure of perceived change in social communication skills. Scores range from 30 - 120. A higher score indicates perception of more impaired skills.
    Time Frame
    Baseline to maintenance (week 12)
    Title
    La Trobe Communication Questionnaire (other-report)
    Description
    The LCQ (other) is a measure of perceived change in social communication skills. Scores range from 30-120. A higher score indicates perception of more impaired skills.
    Time Frame
    Baseline to maintenance (week 12)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of severe traumatic brain injury (TBI) or severe ABI with similar cognitive presentation to TBI Minimum of 6 months post injury Evidence of social communication impairment as a result of injury Ability to tolerate group activity Exclusion Criteria: Significant aphasia Severe depression or psychiatric disorder Insufficient English to converse with peer Profound cognitive impairment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Suzanne Beeke, PhD
    Organizational Affiliation
    University College, London
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Available on request
    IPD Sharing Time Frame
    Starting after publication (2019)
    IPD Sharing Access Criteria
    University College London open access repository
    IPD Sharing URL
    http://discovery.ucl.ac.uk

    Learn more about this trial

    Peer Intervention for Social Skills (Brain Injury)

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