A New Intervention for Social Communication Skills Following Brain Injury
Primary Purpose
Brain Injuries
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Peer facilitator training
Usual care
Sponsored by

About this trial
This is an interventional treatment trial for Brain Injuries focused on measuring Social skills, Social communication, Cognitive communication, Traumatic brain injury, Acquired brain injury, Communication partner training, Peer partner training, Peer mentoring, Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Adults between 18 and 70 years
- A diagnosis of severe traumatic brain injury (TBI) or severe acquired brain injury (ABI) with similar cognitive presentation to TBI
- Minimum of six months post injury
- Evidence of a 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 peers
- Profound cognitive impairment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Peer-led intervention group
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 (LCQ) (self-report)
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).
La Trobe Communication Questionnaire (LCQ) (other-report)
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).
Full Information
NCT ID
NCT02211339
First Posted
August 6, 2014
Last Updated
October 10, 2019
Sponsor
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT02211339
Brief Title
A New Intervention for Social Communication Skills Following Brain Injury
Official Title
An Investigation Into the Effectiveness of a Social Communication Skills Training Programme for Adults Following Brain Injury Using a Peer Learning Model
Study Type
Interventional
2. Study Status
Record Verification Date
October 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 social skills training intervention compared to social activity (usual care) to improve social communication skills following severe brain injury.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
Keywords
Social skills, Social communication, Cognitive communication, Traumatic brain injury, Acquired brain injury, Communication partner training, Peer partner training, Peer mentoring, Rehabilitation
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 group
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 (LCQ) (self-report)
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).
Time Frame
Baseline to maintenance (week 12)
Title
La Trobe Communication Questionnaire (LCQ) (other-report)
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).
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:
Adults between 18 and 70 years
A diagnosis of severe traumatic brain injury (TBI) or severe acquired brain injury (ABI) with similar cognitive presentation to TBI
Minimum of six months post injury
Evidence of a 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 peers
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
Citations:
PubMed Identifier
32408795
Citation
Howell S, Beeke S, Pring T, Varley R. Measuring outcomes of a peer-led social communication skills intervention for adults with acquired brain injury: A pilot investigation. Neuropsychol Rehabil. 2021 Aug;31(7):1069-1090. doi: 10.1080/09602011.2020.1760892. Epub 2020 May 14.
Results Reference
derived
Learn more about this trial
A New Intervention for Social Communication Skills Following Brain Injury
We'll reach out to this number within 24 hrs