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Clinical Trials/NCT03998124
NCT03998124
Completed
N/A

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

University College, London0 sites12 target enrollmentApril 2015
ConditionsBrain Injuries

Overview

Phase
N/A
Intervention
Not specified
Conditions
Brain Injuries
Sponsor
University College, London
Enrollment
12
Primary Endpoint
The Adapted Measure of Participation in Conversation (MPC): Interaction Scale
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
July 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 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.

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.

Secondary Outcomes

  • La Trobe Communication Questionnaire (self-report)(Baseline to maintenance (week 12))
  • La Trobe Communication Questionnaire (other-report)(Baseline to maintenance (week 12))

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