A New Intervention for Social Communication Skills Following Brain Injury

Not Applicable

Completed

• Conditions: Brain Injuries
• Interventions: Behavioral: Peer facilitator training; Other: Usual care

• Registration Number: NCT02211339
• Lead Sponsor: University College, London

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.

Study Timeline

• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-07
• Study Start: 2015-04
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer-led intervention group	Peer facilitator training	Individuals met twice a week for 8 weeks and participated in a peer-mediated social communication skills group.
Staff-led social activity group	Usual care	Individuals met twice a week for 8 weeks and participated in staff-led social activities.

Primary Outcome Measures

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

Name	Time	Method
La Trobe Communication Questionnaire (LCQ) (self-report)	Baseline to maintenance (week 12)	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)	Baseline to maintenance (week 12)	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).