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临床试验/NCT03053557
NCT03053557已完成不适用

Social Skills Coach: An Innovative Multi-Platform Device to Address Social Impairments

Center for Social Innovation, Massachusetts1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2018年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
1
主要终点
Feasibility: 90% recruitment, 75% data completed, 80% technical problems solved

研究概览

简要总结

This study aims to test a new device called the Social Skills Coach that is being created to help mental health consumers with social skills and community functioning. People diagnosed with schizophrenia and clinicians will be included as participants in this study. Mental health consumers (diagnosed with schizophrenia) will be randomly assigned to either test the new device or to participate in a social skills training course. Data will be collected from participants through surveys before participants either use the device or participate the course and afterwards. Individual interviews will be conducted with a sub sample of mental health consumers and clinicians. The study looks to test the credibility and acceptability of the new device to help mental health consumers and clinicians. it will also influence future research.

详细描述

This phase I pilot study tests the feasibility, credibility, and acceptability of the prototype version of Social Skills Coach in terms of its use among mental health consumers and clinicians. The intervention aims to improve social and daily living skills and community functioning among people diagnosed with schizophrenia spectrum disorder. A mixed methods approach will be taken to collect quantitative data at baseline and follow-up. Quantitative data collection includes the use of surveys that comprise validated instruments. Qualitative data collection will occur at the end of the study and will include the use of semi-structured interviews to capture experiential information. Study participants will be randomly assigned to either a social skills training course (control group) or to a study arm using the Social Skills Coach program (treatment group). The study aims to demonstrate proof of concept for a larger effectiveness trial.

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)

盲法说明

Research assistants who conduct assessments with participants will be blinded as to whether participants have been assigned to the intervention or control group.

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Chart diagnosis of schizophrenia spectrum disorder, ability to provide consent, and independent living in the community.
  • •We will obtain written informed consent, and the consent procedure will include an evaluation of capacity to provide consent

排除标准

  • •Under age 21 or not able to provide consent.

研究组 & 干预措施

Social Skills Coach

Experimental

The Social Skills Coach arm of the study will be provided access, instruction, and support for using the newly developed multi-platform device to address social impairments among individuals with schizophrenia, based on the evidence-based Social Skills Training (SST) intervention.

干预措施: Social Skills Coach (Behavioral)

Social Skills Training course

No Intervention

Social Skills Training classes are widely available and regularly used in the study setting. As such, this group will serve as a treatment as usual control group.

结局指标

主要结局

Feasibility: 90% recruitment, 75% data completed, 80% technical problems solved

时间窗: 4 weeks post intervention

Study Process: Recruitment, Retention, Troubleshooting

Credibility: Mean greater than 6 on Expectancy Rating Scale

时间窗: 4 weeks post intervention

Expectancy Rating Scale collected from client participants

Acceptability: 80% of participants engage at least once; 50% of group attendees enter personalized goals; 50% of participants enter an evaluation goal

时间窗: 4 weeks post intervention

Web diagnostics and through Qualitative interviews with client participants and SST trainer participants

次要结局

未报告次要终点

研究者

发起方
Center for Social Innovation, Massachusetts
申办方类型
Other
责任方
Sponsor

研究点 (1)

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