{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T20:21:41Z","timestamp":1787948501857,"version":"build-2784847793"},"reference-count":37,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Med Internet Res"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Limited public understanding of randomized controlled trials (RCTs) hinders recruitment, retention, and confidence in research. Early exposure to trial concepts may strengthen health literacy and research engagement. The Kid\u2019s Trial was a global, decentralized, child-led study that cocreated and conducted an RCT to help children understand trials and their importance and to improve critical thinking.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This paper evaluated the feasibility and methodological implications of engaging children in the cocreation and conduct of a fully online RCT.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n The Kid\u2019s Trial ed a dedicated website guiding children through each step of designing and conducting an RCT. Materials were codeveloped with 2 patient and public involvement groups of children and parents. Any child aged 7-12 years could take part in as many steps as desired. Recruitment combined online and offline strategies, and engagement and self-reported learning were descriptively analyzed. The cocreated Randomized Evaluation of Sleeping With a Toy or Comfort Item (REST) trial was a 2-arm, pragmatic RCT comparing one week of sleeping with a comfort item versus without a comfort item. The primary outcome was sleep-related impairment, and the secondary outcome was overall sleep quality. Analyses followed an intention-to-treat (ITT) approach using mixed effects models adjusted for baseline measures.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Overall, 224 children participated in at least one step of The Kid\u2019s Trial. Participation varied: 37% (n=82) completed one step, and 21% (n=48) completed 6 surveys. The REST trial randomized 139 children, with 73% (n=101) completing outcome surveys. Adjusted mean differences (intervention \u2013 control) were \u22120.53 (95% CI \u22123.40 to 2.34) for sleep-related impairment (\n P<\/jats:italic>\n =.71) and 0.28 (95% CI 0.01-0.55) for sleep quality (\n P<\/jats:italic>\n =.04). The difference was small and was not supported by sensitivity analyses. Poststudy responses (n=20) suggested improved self-reported trial understanding among respondents but were limited by low response rate and potential selection bias.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The Kid\u2019s Trial demonstrates the feasibility of a decentralized, child-led RCT cocreated through participatory citizen-science methods. Children can meaningfully contribute to trial design and conduct, and experiential participation may support engagement with trial concepts. Future studies should enhance engagement through community partnerships, shorter intervals between steps, and embedded learning assessments to improve inclusivity and retention.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/89240","type":"journal-article","created":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T16:50:08Z","timestamp":1780332608000},"page":"e89240-e89240","source":"Crossref","is-referenced-by-count":0,"title":["Feasibility and Methodological Reflections From the Co-Creation of a Randomized Controlled Trial (The Kid\u2019s Trial): Decentralized, Child-Led Citizen-Science Study"],"prefix":"10.2196","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6473-057X","authenticated-orcid":false,"given":"Simone","family":"Lepage","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9569-8290","authenticated-orcid":false,"given":"Laura","family":"Flight","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1900-2773","authenticated-orcid":false,"given":"Nikki","family":"Totton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9393-7075","authenticated-orcid":false,"given":"Declan","family":"Devane","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,8,28]]},"reference":[{"issue":"7126","key":"R1","doi-asserted-by":"publisher","first-page":"201","DOI":"10.1136\/bmj.316.7126.201","article-title":"Understanding controlled trials. Why are randomised controlled trials important?","volume":"316","author":"Sibbald","journal-title":"BMJ"},{"key":"R2","doi-asserted-by":"publisher","DOI":"10.1016\/j.conctc.2018.08.001","article-title":"Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review","volume":"11","author":"Fogel","journal-title":"Contemp Clin Trials Commun"},{"issue":"1","key":"R3","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-022-06415-5","article-title":"Tolerating bad health research: the continuing scandal","volume":"23","author":"Pirosca","journal-title":"Trials"},{"key":"R4","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2021.01.014","article-title":"Transparency, trust and minimizing burden to increase recruitment and retention in trials: a systematic review","volume":"134","author":"Natale","journal-title":"J Clin Epidemiol"},{"issue":"5","key":"R5","doi-asserted-by":"publisher","first-page":"416","DOI":"10.7861\/clinmed.2022-0107","article-title":"Public knowledge and information sources for clinical trials among adults in the USA: evidence from a Health Information National Trends Survey in 2020","volume":"22","author":"Yadav","journal-title":"Clin Med (Lond)"},{"issue":"2","key":"R6","doi-asserted-by":"publisher","first-page":"422","DOI":"10.1016\/j.pec.2020.07.005","article-title":"Improving knowledge and decision readiness to participate in cancer clinical trials: effects of a plain language decision aid for minority cancer survivors","volume":"104","author":"Langford","journal-title":"Patient Educ Couns"},{"issue":"2","key":"R7","doi-asserted-by":"publisher","first-page":"128","DOI":"10.1111\/j.1365-2125.2009.03561.x","article-title":"Promoting public awareness of randomised clinical trials using the media: the \u201cGet Randomised\u201d campaign","volume":"69","author":"Mackenzie","journal-title":"Br J Clin Pharmacol"},{"key":"R8","unstructured":"Increasing clinical trial awareness. Clinical Trials For All. 2025. URL: https:\/\/www.clinicaltrialsforall.org\/ [Accessed 09-08-2026]"},{"issue":"1","key":"R9","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-021-05984-1","article-title":"The people\u2019s trial: supporting the public\u2019s understanding of randomised trials","volume":"23","author":"Finucane","journal-title":"Trials"},{"issue":"2","key":"R10","doi-asserted-by":"publisher","first-page":"81","DOI":"10.1093\/pch\/17.2.81","article-title":"Spotlight on middle childhood: rejuvenating the \u201cforgotten years\u201d","volume":"17","author":"Mah","journal-title":"Paediatr Child Health"},{"key":"R11","volume":"31","author":"Shapiro","journal-title":"Psychoanal Study Child"},{"issue":"1","key":"R12","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-019-3960-9","article-title":"Effects of the informed health choices primary school intervention on the ability of children in Uganda to assess the reliability of claims about treatment effects, 1-year follow-up: a cluster-randomised trial","volume":"21","author":"Nsangi","journal-title":"Trials"},{"key":"R13","unstructured":"Health literacy in the context of health, well-being and learning outcomes: the case of children and adolescents in schools. World Health Organization. 2021. URL: https:\/\/iris.who.int\/handle\/10665\/344901 [Accessed 08-08-2026]"},{"issue":"9","key":"R14","doi-asserted-by":"publisher","first-page":"544","DOI":"10.2471\/BLT.21.287654","article-title":"Infodemics and health misinformation: a systematic review of reviews","volume":"100","author":"Borges do Nascimento","journal-title":"Bull World Health Organ"},{"issue":"1","key":"R15","doi-asserted-by":"publisher","DOI":"10.1017\/cts.2023.597","article-title":"Decentralized clinical trials in the trial innovation network: value, strategies, and lessons learned","volume":"7","author":"Hanley","journal-title":"J Clin Transl Sci"},{"issue":"sup1","key":"R16","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1080\/17434440.2021.2014818","article-title":"Resilient design: decentralized trials recovered faster from the impact of COVID-19 than traditional site-based designs","volume":"18","author":"Price","journal-title":"Expert Rev Med Devices"},{"issue":"1","key":"R17","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-022-00603-y","article-title":"Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion","volume":"5","author":"Goodson","journal-title":"NPJ Digit Med"},{"issue":"6711","key":"R18","doi-asserted-by":"publisher","DOI":"10.1126\/science.adq4994","article-title":"The value of decentralized clinical trials: inclusion, accessibility, and innovation","volume":"385","author":"Jean-Louis","journal-title":"Science"},{"key":"R19","unstructured":"Lepage S Lepage L Devane D . Co-creating with the scientists of tomorrow: shaping trials and the future. The Kid\u2019s Trial. 2025. URL: https:\/\/www.thekidstrial.ie [Accessed 09-08-2026]"},{"issue":"1","key":"R20","doi-asserted-by":"publisher","DOI":"10.1186\/s40900-025-00749-5","article-title":"Lessons learned from building the kid\u2019s trial with an online children\u2019s and parents\u2019 research advisory group: a descriptive, qualitative study","volume":"11","author":"Lepage","journal-title":"Res Involv Engagem"},{"key":"R21","unstructured":"AI-powered insights,backed by real experts. QuestionPro. 2025. URL: https:\/\/www.questionpro.com\/us\/ [Accessed 09-08-2026]"},{"key":"R22","unstructured":"Powtoon homepage. Powtoon Ltd. 2025. URL: www.powtoon.com [Accessed 09-08-2026]"},{"key":"R23","unstructured":"Lepage S . The kid\u2019s trial. YouTube. 2025. URL: https:\/\/www.youtube.com\/@TheKidsTrial [Accessed 09-08-2026]"},{"key":"R24","unstructured":"European citizen science platform. European Citizen Science Association. 2025. URL: https:\/\/citizenscience.eu\/ [Accessed 09-08-2026]"},{"key":"R25","unstructured":"Children helping science homepage. Children Helping Science. 2025. URL: https:\/\/childrenhelpingscience.com\/ [Accessed 09-08-2026]"},{"issue":"5","key":"R26","doi-asserted-by":"publisher","first-page":"657","DOI":"10.1080\/15402002.2018.1461102","article-title":"Qualitative development and content validation of the PROMIS pediatric sleep health items","volume":"17","author":"Bevans","journal-title":"Behav Sleep Med"},{"key":"R27","unstructured":"PROMIS sleep scoring manual. Health Measures. 2022. URL: https:\/\/healthmeasures.net\/select-measures\/measure-library\/ [Accessed 09-08-2026]"},{"issue":"4","key":"R28","doi-asserted-by":"publisher","first-page":"997","DOI":"10.1007\/s11136-020-02700-5","article-title":"Using nationally representative percentiles to interpret PROMIS pediatric measures","volume":"30","author":"Carle","journal-title":"Qual Life Res"},{"issue":"11","key":"R29","doi-asserted-by":"publisher","first-page":"1849","DOI":"10.5664\/jcsm.7478","article-title":"A new single-item sleep quality scale: results of psychometric evaluation in patients with chronic primary insomnia and depression","volume":"14","author":"Snyder","journal-title":"J Clin Sleep Med"},{"key":"R30","doi-asserted-by":"crossref","unstructured":"Lepage S Flight L Totton N Devane D . The REST (randomised evaluation of sleeping with a toy or comfort item) trial: an online, randomised trial of comfort item use on sleep quality in children. medRxiv. Preprint posted online on Feb 6, 2026. [doi: 10.64898\/2026.02.05.26345698]","DOI":"10.64898\/2026.02.05.26345698"},{"key":"R31","doi-asserted-by":"publisher","DOI":"10.1016\/j.conctc.2025.101580","article-title":"The REST (randomised evaluation of sleeping with a toy or comfort item) trial: a protocol for an online, randomised trial of comfort item use on sleep quality in children","volume":"48","author":"Lepage","journal-title":"Contemp Clin Trials Commun"},{"key":"R32","unstructured":"Lepage S Flight L Totton N Devane D . The REST (randomised evaluation of sleeping with a toy or comfort item) trial OSF repository. Open Science Framework. 2025. URL: https:\/\/osf.io\/wu7q3\/overview [Accessed 09-08-2026]"},{"key":"R33","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2024-081123","article-title":"CONSORT 2025 statement: updated guideline for reporting randomised trials","volume":"389","author":"Hopewell","journal-title":"BMJ"},{"key":"R34","unstructured":"Kolb D . Experiential Learning: Experience as the Source of Learning and Development. Prentice Hall; 1984. ISBN: 0132952610"},{"issue":"1","key":"R35","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-020-4130-9","article-title":"Can learning about trials be child\u2019s play? A qualitative exploration of the \u201cSchools Teaching Awareness of Randomised Trials\u201d (START) initiative","volume":"21","author":"Biesty","journal-title":"Trials"},{"issue":"2","key":"R36","doi-asserted-by":"publisher","first-page":"168","DOI":"10.1098\/rsbl.2010.1056","article-title":"Blackawton bees","volume":"7","author":"Blackawton","journal-title":"Biol Lett"},{"key":"R37","unstructured":"Union measuring digital development: facts and figures 2024. International Telecommunication Union. 2024. URL: https:\/\/www.itu.int\/en\/ITU-D\/Statistics\/pages\/facts\/default.aspx [Accessed 09-08-2026]"}],"container-title":["Journal of Medical Internet Research"],"original-title":[],"language":"en","deposited":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T20:11:25Z","timestamp":1787947885000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.jmir.org\/2026\/1\/e89240"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,28]]},"references-count":37,"URL":"https:\/\/doi.org\/10.2196\/89240","relation":{},"ISSN":["1438-8871"],"issn-type":[{"value":"1438-8871","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,28]]},"article-number":"v28i7126e89240"}}