Improving Well-being Among Young Adult Survivors of Childhood Brain Tumor: A Randomized Controlled Trial of a Brief Internet-based Behavioral Activation Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Change from baseline PERMA-Profiler score at 2 weeks and 3 months
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of an Internet-based, behavioral activation intervention to promote well-being in a young adult survivors of childhood brain tumor.
详细描述
Participants will be recruited through the Children's Brain Tumor Foundation who will share the study announcement with their young adult members and social media. Eligible participants will complete a baseline battery survey via Qualtrics. The investigators will recruit 120 participants. The survey will take approximately 30 minutes to complete. Participants will be randomly assigned to an experimental group or control group. The experimental group will take an Internet-based behavioral activation intervention. The intervention has four modules and will be administered via Qualtrics. A link to each module will be sent to the participants via e-mail. Participants will have one week to complete each module. Once a participant completes a module, the next module link will be sent after 3 days. A reminder will be sent at 7 days and 10 days until the module is complete. Each module will take approximately 30 minutes to complete. The experimental group may continue to receive services as usual from the Children's Brain Tumor Foundation. The control group will continue to receive services as usual from the Children's Brain Tumor Foundation. The control group will have an opportunity to take the intervention once data collection is complete. Both groups will be asked to complete a battery of surveys at the end of the intervention and intermittently over a 3-month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Investigators and participants will know which arm of the study participants are randomly assigned to.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of childhood brain tumor
- •Ages of 18 and 30 years.
- •Have regular access to the Internet
- •Provide an e-mail address
排除标准
- •Those that do not meet the inclusion criteria.
结局指标
主要结局
Change from baseline PERMA-Profiler score at 2 weeks and 3 months
时间窗: At baseline; 2 weeks and 3 months after completing the intervention.
The PERMA-Profiler is a general measure of well-being (Butler \& Kern, 2016). The PERMA-Profiler measures Seligman's (2011) five pillars of well-being: positive emotion, engagement, relationships, meaning, and accomplishment. The measure consists of 23 items, including three items for each domain. The health, negative emotion, loneliness, and overall happiness items act as filler questions and provide more information. Items are rated on an 11-point Likert scale ranging from 0 (never) to 10 (always), or 0 (not at all) to 10 (completely). Scores are calculated as the average of the items comprising each factor. Butler and Kern (2016) suggested that the multidimensional structure be retained, rather than condensing responses; however, a single well-being score may provide a global indication of well-being. Therefore, for the current study, total scores for each subscale will be calculated as well as the total scores. Change from baseline total score will be assessed.
次要结局
- Change in baseline Perceived Stress Scale score at 2 weeks and 3 months(At baseline; 2 weeks and 3 months after completing the intervention.)
- Change in baseline Vocational Outcomes Expectancy Scale score at 2 weeks and 3 months(At baseline; 2 weeks and 3 months after completing the intervention.)
- Change in baseline Perceived Barrier Scale score at 2 weeks and 3 months(At baseline; 2 weeks and 3 months after completing the intervention.)
- Change from baseline World Health Organization-Disability Assessment Schedule 2.0 score at 2 weeks and 3 months(At baseline; 2 weeks and 3 months after completing the intervention.)
- Change from baseline Life Satisfaction Scale (LiSat-9) score at 2 weeks and 3 months(At baseline; 2 weeks and 3 months after completing the intervention.)
- Change in baseline Acceptance and Action Questionnaire (AAQ-II) score at 2 weeks and 3 months(At baseline; 2 weeks and 3 months after completing the intervention.)
- Change in baseline Behavioral Activation for Depression Scale (BADS-9) score at 2 weeks and 3 months(At baseline; 2 weeks and 3 months after completing the intervention.)
- Change in baseline Cognitive-Behavioral Social Self-Efficacy Scale score at 2 weeks and 3 months(At baseline; 2 weeks and 3 months after completing the intervention.)
- Change in baseline General Self-Efficacy Scale score at 2 weeks and 3 months(At baseline; 2 weeks and 3 months after completing the intervention.)