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Completed

NCT Number: NCT03998124

Peer Intervention for Social Skills (Brain Injury)

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).

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer facilitator training

Behavioral

Peer facilitation of a project-based activity without staff present

Usual Care

Other

Staff-led social activity

Primary outcomes

  1. The Adapted Measure of Participation in Conversation (MPC): Interaction Scale

    Time frame: Baseline to maintenance (week 12)

    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.

  2. The Adapted Measure of Participation in Conversation (MPC): Transaction Scale

    Time frame: Baseline to maintenance (week 12)

    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.

  3. The Interactional Network Tool (INT)

    Time frame: Baseline to maintenance (week 12)

    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.

Secondary outcomes

  1. La Trobe Communication Questionnaire (self-report)

    Time frame: Baseline to maintenance (week 12)

    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.

  2. La Trobe Communication Questionnaire (other-report)

    Time frame: Baseline to maintenance (week 12)

    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.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 26, 2019
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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