Peer Intervention for Social Skills (Brain Injury)

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

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).

Study Overview

• Status: Completed
• Conditions: Brain Injuries
• Intervention / Treatment: Behavioral: Peer facilitator training; Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Suzanne Beeke, PhD, University College, London

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: 13/0477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No