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出境医 / 临床实验 / Peer Intervention for Social Skills (Brain Injury)

Peer Intervention for Social Skills (Brain Injury)

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).

Condition or disease Intervention/treatment Phase
Brain Injuries Behavioral: Peer facilitator training Other: Usual care Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An experimental parallel group design
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Peer-led Intervention for Social Communication Skills Following Brain Injury (Main Study)
Actual Study Start Date : April 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015
Arms and Interventions
Arm Intervention/treatment
Experimental: Peer-led intervention
Individuals met twice a week for 8 weeks and participated in a peer-mediated social communication skills group.
 Behavioral: Peer facilitator training
Peer facilitation of a project-based activity without staff present
Active Comparator: Staff-led social activity group
Individuals met twice a week for 8 weeks and participated in staff-led social activities.
 Other: Usual care
Staff-led social activity
Outcome Measures
Primary Outcome Measures :
  1. The Adapted Measure of Participation in Conversation (MPC): Interaction Scale [ Time Frame: Baseline to maintenance (week 12) ]
    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.

  2. The Adapted Measure of Participation in Conversation (MPC): Transaction Scale [ Time Frame: Baseline to maintenance (week 12) ]
    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.

  3. The Interactional Network Tool (INT) [ Time Frame: Baseline to maintenance (week 12) ]
    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 :
  1. La Trobe Communication Questionnaire (self-report) [ Time Frame: Baseline to maintenance (week 12) ]
    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.

  2. La Trobe Communication Questionnaire (other-report) [ Time Frame: Baseline to maintenance (week 12) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Suzanne Beeke, PhD University College, London
Tracking Information
First Submitted Date  ICMJE June 24, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date July 11, 2019
Actual Study Start Date  ICMJE April 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • The Adapted Measure of Participation in Conversation (MPC): Interaction Scale [ Time Frame: Baseline to maintenance (week 12) ]
    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 [ Time Frame: Baseline to maintenance (week 12) ]
    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) [ Time Frame: Baseline to maintenance (week 12) ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • The Adapted Measure of Participation in Conversation (MPC): Interaction Scale [ Time Frame: Baseline to maintenance (week 12) ]
    A measure of verbal and non-verbal participation in conversation.
  • The Adapted Measure of Participation in Conversation (MPC): Transaction Scale [ Time Frame: Baseline to maintenance (week 12) ]
    A measure of the ability to share and request information in conversation.
  • The Interactional Network Tool (INT) [ Time Frame: Baseline to maintenance (week 12) ]
    A new measure of group social participation developed for this study.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • La Trobe Communication Questionnaire (self-report) [ Time Frame: Baseline to maintenance (week 12) ]
    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) [ Time Frame: Baseline to maintenance (week 12) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • La Trobe Communication Questionnaire (self-report) [ Time Frame: Baseline to maintenance (week 12) ]
    A measure of perceived change change in social communication skills
  • La Trobe Communication Questionnaire (other-report) [ Time Frame: Baseline to maintenance (week 12) ]
    A measure of perceived change in social communication skills
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peer Intervention for Social Skills (Brain Injury)
Official Title  ICMJE A Peer-led Intervention for Social Communication Skills Following Brain Injury (Main Study)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
An experimental parallel group design
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Brain Injuries
Intervention  ICMJE
  • Behavioral: Peer facilitator training
    Peer facilitation of a project-based activity without staff present
  • Other: Usual care
    Staff-led social activity
Study Arms  ICMJE
  • Experimental: Peer-led intervention
    Individuals met twice a week for 8 weeks and participated in a peer-mediated social communication skills group.
    Intervention: Behavioral: Peer facilitator training
  • Active Comparator: Staff-led social activity group
    Individuals met twice a week for 8 weeks and participated in staff-led social activities.
    Intervention: Other: Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2019) 		12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03998124
Other Study ID Numbers  ICMJE 13/0477
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Available on request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Starting after publication (2019)
Access Criteria: University College London open access repository
URL: http://discovery.ucl.ac.uk
Responsible Party University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Suzanne Beeke, PhD University College, London
PRS Account University College, London
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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