Developing the Unified Protocol-Single Session Experience Platform for Adolescent Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Module Knowledge
研究概览
简要总结
This SBIR Phase I proposal will develop and test the acceptability and feasibility of a new suite of digital Single-Session Interventions, specifically applying Unified Protocol core principles for emotional disorders, to produce a highly accessible, engaging, and scalable product to help address the clinical needs of youth.
详细描述
This project proposes develop a suite of Single Session Intervention (SSI) modules using the Unified Protocol (UP) core principles. For Phase I, the team will develop two SSI modules from UP: Awareness of Physical Sensations and Emotional Experiences, and Being Flexible in Your Problem Solving. For the acceptability test (Specific Aim 2), investigators will recruit 60 youth who are screened as eligible based on the internalizing subscale of the Pediatric Symptom Checklist. Caregivers/parents of youth will be recruited using targeted social media advertisements, where they can view a brief study description and complete the eligibility screener. If interested, caregivers can provide contact information for the study team to conduct consent and assent processes. Following consent and enrollment, participants will receive private login information to access the prototype and study materials. First, participants will complete pre-surveys that collect demographic information and responses to the Revised Children's Anxiety and Depression Scale (RCADS). Next, participants will take a brief survey to assess knowledge of intervention concepts presented in the first module: Mindful Awareness. Then, they will engage with the module and provide feedback on the quality of its components. Then, they will complete the knowledge assessment again. Participants will complete the same process for the second module: Flexible Problem Solving (pre knowledge check, review, rate the quality, and post knowledge check). Participants will complete a product evaluation to rate their overall experience with the prototype (quality, usability, innovation, feasibility, and value) and the degree they advocate for full product development. Finally, participants will take the RCADS at the end of the review period. There will also be an opportunity for participants to participate in a brief feedback call to provide additional feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be ages 13 to 17 years old
- •be willing and available to take part in the study requirements
- •be fluent in English
- •have access to the internet with a mobile device or personal computer
- •have parent permission
- •screen as eligible according to the internalizing subscale from the Pediatric Symptom Checklist
排除标准
- 未提供
结局指标
主要结局
Module Knowledge
时间窗: Average of 2 weeks apart, as pre- and post-tests
Adolescents will complete this 9-item measure to determine what they know about key concepts taught in the CBToolkit module prior to and following review of the modules. The measure includes 9 multiple choice items with a 1 correct response per item. Total scores are based on the number of items with correct responses and range from 0 to 9. Higher scores reflect more correct responses.
Program Feedback Scale for Adolescents
时间窗: 2 week followup post module review
Adolescents will complete this 12-item measure, rating the extent to which they agree with statements about the usability, acceptability, and feasibility of the CBToolkit modules. The measure includes 9 Likert items and 3 open-ended items. Responses to the Likert items range from 1 (Really Disagree) to 5 (Really Agree). Total scores are based on the Likert items are range from 0 to 45. Higher scores reflect more positive opinions.
Revised Children's Anxiety and Depression Scale- Shortened
时间窗: Average of 2 weeks apart, as pre- and post-tests
Adolescents will complete the shortened 11-item version of this measure to assess levels of anxiety and depression prior to and following review of the modules. The measure includes 11 Likert items. Responses to the Likert items range from 0- Never to 3- Always. Total scores are based on the Likert items are range from 0 to 33. Higher scores reflect more severe symptoms.
次要结局
- Usage Metrics from the CBToolkit system for adolescents(The period in which adolescents interact with the system, approximately 2 weeks)
- Feedback interviews with adolescents(15-minutes, completed after the test of the CBToolkit system)