A New Intervention for Social Communication Skills Following Brain Injury

Brain Injuries Clinical Trial

Official title:

An Investigation Into the Effectiveness of a Social Communication Skills Training Programme for Adults Following Brain Injury Using a Peer Learning Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211339
• Other study ID #: UCL JRO ref: 13/0477
• Secondary ID: 14/SC/0048
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: July 2015

Study information

• Verified date: October 2019
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Peer facilitator training
Peer facilitation of a project-based activity without staff present

Other:
• Usual care
Staff-led social activity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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).	Baseline to maintenance (week 12)
Secondary	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).	Baseline to maintenance (week 12)