NCT02211339

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

August 6, 2014

Last Update Submit

October 10, 2019

Conditions

Brain Injuries

Keywords

Social skillsSocial communicationCognitive communicationTraumatic brain injuryAcquired brain injuryCommunication partner trainingPeer partner trainingPeer mentoringRehabilitation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • La Trobe Communication Questionnaire (LCQ) (self-report)

    Baseline to maintenance (week 12)

  • La Trobe Communication Questionnaire (LCQ) (other-report)

    Baseline to maintenance (week 12)

Study Arms (2)

Peer-led intervention group

EXPERIMENTAL

Individuals met twice a week for 8 weeks and participated in a peer-mediated social communication skills group.

Behavioral: Peer facilitator training

Staff-led social activity group

ACTIVE COMPARATOR

Individuals met twice a week for 8 weeks and participated in staff-led social activities.

Other: Usual care

Interventions

Peer facilitator trainingBEHAVIORAL

Peer facilitation of a project-based activity without staff present

Peer-led intervention group
Usual careOTHER

Staff-led social activity

Staff-led social activity group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant aphasia
  • Severe depression or psychiatric disorder
  • Insufficient English to converse with peers
  • Profound cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Howell S, Beeke S, Pring T, Varley R. Measuring outcomes of a peer-led social communication skills intervention for adults with acquired brain injury: A pilot investigation. Neuropsychol Rehabil. 2021 Aug;31(7):1069-1090. doi: 10.1080/09602011.2020.1760892. Epub 2020 May 14.

    PMID: 32408795DERIVED

MeSH Terms

Conditions

Brain InjuriesSocial SkillsCommunicationBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesSocial BehaviorBehavior

Study Officials

  • Suzanne Beeke, PhD

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: An experimental parallel group design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 7, 2014

Study Start

April 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 14, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

Available on request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Starting after publication (2019)
Access Criteria
University College London open access repository
More information