A Peer-led Intervention for Social Communication Skills Following Brain Injury (Main Study)
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): Interaction Scale
研究概览
简要总结
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).
详细描述
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.
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
- 否
入选标准
- •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
排除标准
- •Significant aphasia
- •Severe depression or psychiatric disorder
- •Insufficient English to converse with peer
- •Profound cognitive impairment
研究组 & 干预措施
Peer-led intervention
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
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): 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.
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.
次要结局
- La Trobe Communication Questionnaire (self-report)(Baseline to maintenance (week 12))
- La Trobe Communication Questionnaire (other-report)(Baseline to maintenance (week 12))