Web-based Resource for Youth About Clinical Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Change in Attitudes toward Clinical Research
研究概览
简要总结
This study will evaluate DigiKnowIt News, a web-based resource to educate youth about pediatric clinical research. Youth will be randomly assigned to one of three groups (1. Intervention Version A; 2) Intervention Version B; 3) Wait-list control).
详细描述
Compared to the high numbers of clinical trials with adults, there are far fewer clinical trials with children and adolescents; highlighting the need for more clinical trials with pediatric populations. Lacking in the area of pediatric clinical research are resources to educate children and adolescents about clinical research in fun, interactive, and developmentally appropriate ways. Thus, a web-based resource, DigiKnowIt News, was developed for youth aged 8 to 14 years to educate youth about participating in pediatric clinical trials. The web-based resource includes video spotlights, investigations, and electronic comic books. The purpose of this study is to conduct a randomized controlled trial to determine the effectiveness of the web-based resource and examine its impact on youths' knowledge about pediatric clinical trials, self-efficacy about making decisions about participation in clinical research, and positive attitudes towards participation.
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 (Participant)
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Within the ages of 8 and 14 years of age
排除标准
- •Does not speak English fluently, does not have access to a computer or tablet with internet connection, and or has participated in a clinical trial after kindergarten.
研究组 & 干预措施
Intervention Version A
Youth will be asked to complete a version of DigiKnowIt News that includes investigations, comics, and spotlight videos that focus on four topic areas related to participating in clincial trials. Version A will include an additional topic area.
干预措施: DigiKnowIt News (Behavioral)
Intervention Version B
Youth will be asked to complete a version of DigiKnowIt News that includes investigations, comics, and spotlight videos that focus on four topic areas related to participating in clincial trials. Version B will include an additional topic area (different than in Version A).
干预措施: DigiKnowIt News (Behavioral)
Wait-List Control
Youth will not have access to DigiKnowIt News until after the post-test timepoint.
结局指标
主要结局
Change in Attitudes toward Clinical Research
时间窗: 2 weeks
Questions will assess youth's attitudes toward pediatric clinical research on a 3-point Likert rating scale.
Change in Self-Efficacy for Making Decisions
时间窗: 2 weeks
Questions will assess youth's self-efficacy for making decisions using a 5-point Likert scale.
Change in Knowledge about Clinical Research
时间窗: 2 weeks
Questions will assess youth's factual knowledge about clinical research using a multiple choice format.
次要结局
- Changes in Initiative-Taking(2 weeks)
- Consumer Satisfaction(1 day)
- Changes in Hope(2 weeks)
- Changes in Parent-Child Communication(2 weeks)
研究者
Alison Parker
Research Scientist II
Innovation Research & Training