Overview

This trial is active, not recruiting.

Condition brain injuries
Treatments peer tutor training, usual care
Sponsor University College, London
Start date June 2014
End date December 2016
Trial size 24 participants
Trial identifier NCT02211339, 14/SC/0048, UCL JRO ref: 13/0477

Summary

The purpose of this study is to investigate whether a peer led social skills training intervention is more effective than a social activity group (i.e. usual care) in improving social skills following brain injury.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
This group meets twice each week for 8 weeks. Peer tutor training is provided.
peer tutor training
Peer tutor training to meet the interaction needs of the group.
(Active Comparator)
Staff led social activities organised in group setting, meeting twice each week for 8 weeks. Usual care.
usual care
Usual care

Primary Outcomes

Measure
Behaviorally-Referenced Rating System of Intermediate Social Skills - Revised (BRISS-R)
time frame: Change from baseline in BRISS-R at week 8 (follow-up measure)
Behaviorally-Referenced Rating System of Intermediate Social Skills - revised (BRISS-R)
time frame: Change from baseline in BRISS-R to maintenance assessment (week 12)
Profile of Pragmatic Impairments in Communication (PPIC)
time frame: Change from baseline in PPIC at follow-up (week 8)
The Profile of Pragmatic Impairment in Communication (PPIC)
time frame: Change from baseline in PPIC to maintenance assessment (week 12)
The Adapted Measure of Participation in Conversation (MPC)
time frame: Change from baseline in MPC at follow-up (week 8)
The Adapted Measure of Participation in Communication (MPC)
time frame: Change from baseline in MPC to maintenance assessment in week 12

Secondary Outcomes

Measure
Manual interaction analysis
time frame: Change from baseline to follow-up point (week 8)
Manual interaction analysis
time frame: Change from baseline to maintenance assessment (week 12)
Satisfaction questionnaire
time frame: Week 12
La Trobe Communication Questionnaire
time frame: Week 12

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Adults between 18 and 70 years - A diagnosis of severe TBI (measured by post traumatic amnesia exceeding 24 hours or by other neurological evidence, such as surgery to reduce intracranial swelling, or other persisting neurological signs), or severe acquired brain injury with similar cognitive presentation to TBI (measured by a Glasgow Coma Scale score of less than 9 or other persisting neurological signs) - Occurrence of injury at least six months prior to the study - Evidence of a social communication impairment as a result of the injury - Ability to tolerate group activity Exclusion Criteria: - Extensive cognitive impairment preventing active involvement in programmes of rehabilitation - Insufficient English to converse with peers - Significant aphasia (a disorder affecting both the understanding and use of language) - Severe depression or a psychiatric disorder impeding participation in group activity

Additional Information

Official title An Investigation Into the Effectiveness of a Social Communication Skills Training Programme for Adults Following Severe Traumatic Brain Injury (TBI) Using a Peer-to-peer Learning Model
Principal investigator Suzanne Beeke, PhD
Description The study will take place in two phases. The pilot phase (n =12) will test the feasibility of the approach. Following a period of analysis and fine-tuning, the protocol for the second phase of the study (n=12) will be adapted in the light of pilot study results.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University College, London.