Peer Intervention for Social Skills (Brain Injury)

NCT03998124 | Completed DMC

• 1 other identifier: 13/0477
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Brain Injuries

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 (self-report)

  Baseline to maintenance (week 12)

• La Trobe Communication Questionnaire (other-report)

  Baseline to maintenance (week 12)

Study Arms (2)

Peer-led intervention

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 training BEHAVIORAL

Peer facilitation of a project-based activity without staff present

Peer-led intervention

Usual care OTHER

Staff-led social activity

Staff-led social activity group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An experimental parallel group design

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: April 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 11, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting after publication (2019)
• Access Criteria: University College London open access repository