Efficacy of DigiKnowItNews: Teen, a multimedia educational website for adolescents about pediatric clinical trials: study protocol for a randomized controlled trial.
Efficacy of DigiKnowItNews: Teen, a multimedia educational website for adolescents about pediatric clinical trials: study protocol for a randomized controlled trial.
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儿科研究对于开发新的科学进步、治疗方法和针对青少年的疗法至关重要。然而，由于成功招募和保留障碍（包括对临床试验的知识和态度），儿科临床试验的开展相对较少。青少年往往拥有更大的决策自主权，并表示有兴趣参与临床试验的决策。增加与临床试验相关的知识、积极态度和自我效能可能会对参与儿科临床试验的决定产生积极影响。然而，目前很少有交互式的、适合发育的、基于网络的资源可用于教育青少年有关临床试验的知识。 DigiKnowItNews：Teen 是一个多媒体教育网站，旨在解决儿科临床试验的入学率相对较低的问题，以及帮助青少年做出有关参与临床试验的决定的信息需求。这是一项平行组随机对照优效性试验，旨在测试 DigiKnowItNews: Teen 的有效性，以改善青少年和家长参与临床试验的相关因素。符合资格的父母与青少年（12 至 17 岁）配对将被随机分配到以下两种情况之一：干预或等候名单控制。所有参与者都将完成测试前和测试后调查问卷，分配参与干预的参与者将有权查看 DigiKnowItNews：青少年内容 1 周。等待名单控制参与者可以选择在研究完成后查看 DigiKnowItNews：青少年。主要结果是关于临床研究的知识、对儿科临床试验的态度和信念、做出与临床试验参与相关的决策的自我效能、参与未来临床试验的意愿、程序恐惧以及家长与青少年的沟通质量。还将收集与 DigiKnowItNews: Teen 相关的总体反馈和满意度。该试验将评估 DigiKnowIt News: Teen 的有效性，这是一个有关青少年儿科临床试验的教育网站。如果发现可以有效促进与未来儿科临床试验参与相关的因素，DigiKnowIt News: Teen 可以被青少年及其父母在做出参与临床试验的决定时使用。临床试验研究人员还可以使用 DigiKnowIt News: Teen 来帮助他们的参与者招募工作。 ClinicalTrials.gov NCT05714943。注册于 2023 年 2 月 3 日。
Pediatric research is crucial for the development of new scientific advancements, treatments, and therapies for adolescents. Yet relatively few pediatric clinical trials are conducted due to barriers to successful recruitment and retention, including knowledge and attitudes about clinical trials. Adolescents tend to experience greater autonomy to make decisions and have expressed interest in being part of the decision to participate in clinical trials. Increasing knowledge, positive attitudes, and self-efficacy related to clinical trials could positively impact the decision to participate in a pediatric clinical trial. However, there are currently few interactive, developmentally appropriate, web-based resources available to educate adolescents about clinical trials. DigiKnowItNews: Teen was created as a multimedia educational website to address the relatively low levels of enrollment in pediatric clinical trials and need for information to empower adolescents to make decisions about participating in clinical trials. This is a parallel group randomized controlled superiority trial to test the effectiveness of DigiKnowItNews: Teen, for improving factors related to clinical trial participation among adolescent and parents. Eligible parent-adolescent (ages 12 to 17 years) pairs will be randomly assigned to one of two conditions: intervention or wait-list control. All participants will complete pre- and post-test questionnaires and participants assigned to the intervention will receive access to review the DigiKnowItNews: Teen content for 1 week. Wait-list control participants will have the option to review DigiKnowItNews: Teen after study completion. The primary outcomes are knowledge about clinical research, attitudes, and beliefs toward pediatric clinical trials, self-efficacy for making decisions related to clinical trial participation, willingness to participate in a future clinical trial, procedural fears, and parent-adolescent communication quality. Overall feedback and satisfaction related to DigiKnowItNews: Teen will also be collected. The trial will evaluate the effectiveness of DigiKnowIt News: Teen, an educational website about pediatric clinical trials for adolescents. If found effective in promoting factors related to future pediatric clinical trial participation, DigiKnowIt News: Teen could be used by adolescents, along with their parents, as they make the decision to participate in a clinical trial. Clinical trial researchers can also use DigiKnowIt News: Teen to aid their participant recruitment efforts. ClinicalTrials.gov NCT05714943. Registered on 02/03/2023.
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影响因子：
11.1
作者：
Madsen, SM;Mirza, MR;Riis, P
通讯作者：
Riis, P
影响因子：
1.5
作者：
Greenberg RG;Gamel B;Bloom D;Bradley J;Jafri HS;Hinton D;Nambiar S;Wheeler C;Tiernan R;Smith PB;Roberts J;Benjamin DK Jr
通讯作者：
Benjamin DK Jr
影响因子：
3.2
作者：
Bucci-Rechtweg, Christina
通讯作者：
Bucci-Rechtweg, Christina
影响因子：
3.7
作者：
Denhoff ER;Milliren CE;de Ferranti SD;Steltz SK;Osganian SK
通讯作者：
Osganian SK
影响因子：
3.6
作者：
Scull TM;Carl AE;Keefe EM;Malik CV
通讯作者：
Malik CV