Group Based Treatment for Persons With Social Communication Difficulties: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- La Trobe Questionnaire.
研究概览
简要总结
A large proportion of patients with ABI have cognitive deficits that affect the way they communicate. Cognitive difficulties with attention, memory, executive functions and so on affect social communication. Without successful social skills, a person may engage in conflicts, become isolated and be denied access to social and vocational opportunities. Internationally, several group interventions have been developed for treating social communication difficulties during the last years.
Group Interactive Structured Treatment (GIST) is a validated holistic multidisciplinary group treatment targeting social communication skills after traumatic brain injury. The main aim of the present study is to examine the efficacy of GIST for improving social communication in persons with acquired brain injury, including TBI, stroke, tumor ect. Secondary the study aims to compare the standard GIST protocol to an newly developed intensive GIST protocol. Efficacy will be assessed immediately after intervention, but also three and six months after the intervention. The project is in line with international research efforts aimed to establish more knowledge about group treatment for persons with social communication disorders after ABI.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •traumatic brain injury (TBI), cerebrovascular accidents (stroke; CVA) patients with no concomitant diseases minimum 6 months post-injury
- •The patient are experiencing social communication disorders
- •The family member is experiencing the patients social communication disorders
- •The patient is motivated and expresses a desire to change communication behavior
- •One close family member is able to participate in the intervention process
- •Adequate Norwegian language proficiency to participate in the group
- •The patient experiences moderate to severe difficulties with minimum 3 aspects of communication assessed with La Trobe Questionnaire
- •The patient have insight into their communication difficulties (minimum intellectual insight) assessed with Awareness Questionnaire
排除标准
- •Age <18 years
- •Aphasia. Based on previous records.
- •Major psychiatric disorder or reported ongoing alcohol or substance abuse
- •Premorbid neurological disease or insult and/or comorbid neurological disease
- •Impaired basic linguistic, mnemonic, motor, or perceptual function that can interfere with the ability to engage with the training or intelligence quotient (IQ) < 85
研究组 & 干预措施
Standard GIST
Standard Group Interactive Structured Treatment.
干预措施: Standard GIST (Behavioral)
Waitlist control/Intensive GIST
After a wait list control period of nine months the participants receive Intensive Group Interactive Structured Treatment.
干预措施: Intensive GIST (Behavioral)
结局指标
主要结局
La Trobe Questionnaire.
时间窗: Change from baseline up to 6 months
The LaTrobe Communication Questionnaire (LCQ) is a 30-item questionnaire that measures communication ability, a subjective outcome measure. Various communication behaviours are rated on a 4-point scale: 1¼never or rarely, 2¼sometimes, 3¼often and 4¼usually or always, but six items require a reverse in the scoring. Higher scores reflect reduced communications skills. The tool was developed to obtain information from various sources (e.g. self -rating by individual with TBI, rating by support person).
次要结局
- Social competence checklist(Change from baseline up to 6 months)
- Symptom Checklist (SCL-10)(Change from baseline up to 6 months)
- Goal Attainment Scaling (GAS)(Change from baseline up to 6 months)
- Profile of Pragmatic Impairment in Communication (PPIC)(Change from baseline up to 6 months)
- CIQ (Community Integration Questionnaire)(Change from baseline up to 6 months)
- Norwegian Version of the General Perceived Self-Efficacy Scale(Change from baseline up to 6 months)
- Norwegian Quality of Life Scale (PQoL),(Change from baseline up to 6 months)
- Mind in the eyes test(Change from baseline up to 6 months)
- Social Communication Questionnaire with additional questions (SCQ-A)(Change from baseline up to 6 months)
- Behavior Rating Inventory for Executive Functions (BRIEF)(Change from baseline up to 6 months)
研究者
Silje Merethe Hansen
Co-Principal Investigator
Sunnaas Rehabilitation Hospital