Peer Intervention for Social Skills (Brain Injury)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Peer-led Intervention for Social Communication Skills Following Brain Injury (Main Study)

Conditions
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Brain Injuries

Intervention / Treatment
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* Behavioral: Peer facilitator training
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An experimental parallel group design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer-led intervention<br>Individuals met twice a week for 8 weeks and participated in a peer-mediated social communication skills group. | Behavioral: Peer facilitator training<br>* Peer facilitation of a project-based activity without staff present<br>|
| Active Comparator: Staff-led social activity group<br>Individuals met twice a week for 8 weeks and participated in staff-led social activities. | Other: Usual care<br>* Staff-led social activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to maintenance (week 12) | 
| 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. | Baseline to maintenance (week 12) | 
| 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. | Baseline to maintenance (week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to maintenance (week 12) | 
| 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. | Baseline to maintenance (week 12) |