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临床试验/NCT02211339
NCT02211339已完成不适用

An Investigation Into the Effectiveness of a Social Communication Skills Training Programme for Adults Following Brain Injury Using a Peer Learning Model

University College, London0 个研究点目标入组 12 人开始时间: 2015年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
主要终点
The Adapted Measure of Participation in Conversation (MPC): Transaction Scale

研究概览

简要总结

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.

详细描述

A pilot study first tested the feasibility of the approach and the sensitivity of existing outcome measures to changes in group social interaction. Following amendments to the pilot protocol, twelve new participants with severe ABI were recruited from a residential post-acute rehabilitation centre in April 2015. 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 in 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Peer-led intervention group

Experimental

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

干预措施: Peer facilitator training (Behavioral)

Staff-led social activity group

Active Comparator

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

干预措施: Usual care (Other)

结局指标

主要结局

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

时间窗: 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.

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

时间窗: 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.

The Interactional Network Tool (INT)

时间窗: 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.

次要结局

  • La Trobe Communication Questionnaire (LCQ) (self-report)(Baseline to maintenance (week 12))
  • La Trobe Communication Questionnaire (LCQ) (other-report)(Baseline to maintenance (week 12))

研究者

申办方类型
Other
责任方
Sponsor

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