Peer-reviewed article
Feasibility and Methodological Reflections From the Co-Creation of a Randomized Controlled Trial (The Kid's Trial): Decentralized, Child-Led Citizen-Science Study.
Lepage S, Flight L, Totton N, Devane D ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001The Kid's Trial was a global online study where children aged 7-12 co-designed and conducted a randomized controlled trial to improve their understanding of research methods and critical thinking. Children participated in designing and running the REST trial, which tested whether sleeping with a comfort item improved sleep quality. While 224 children engaged with at least one step of the trial, participation varied considerably, and the intervention showed minimal effects on sleep outcomes. The study demonstrates that children can meaningfully participate in research design and conduct, though engagement and retention need improvement.
Key points
- 224 children participated in at least one step of The Kid's Trial, with 21% (n=48) completing all 6 surveys
- The REST trial randomized 139 children; 73% (n=101) completed outcome surveys
- Sleeping with a comfort item showed no meaningful effect on sleep-related impairment (mean difference -0.53, P=.71)
- Post-study responses (n=20) suggested improved trial understanding among respondents, but response rate was low
- Children can meaningfully contribute to trial design and conduct through participatory citizen-science methods
Limitations
The study had low retention across steps and low post-study response rate (20 respondents), limiting confidence in learning outcome findings. The effectiveness of the comfort item intervention itself cannot be determined from this data due to small differences and lack of support from sensitivity analyses.
Abstract
Background 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's 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. Objective This paper evaluated the feasibility and methodological implications of engaging children in the cocreation and conduct of a fully online RCT. Methods The Kid's 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. Results Overall, 224 children participated in at least one step of The Kid's 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 - control) were -0.53 (95% CI -3.40 to 2.34) for sleep-related impairment (P=.71) and 0.28 (95% CI 0.01-0.55) for sleep quality (P=.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. Conclusions The Kid's 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.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Child-led cocreation and conduct of a fully online randomized controlled trial (REST trial) comparing one week of sleeping with a comfort item versus without a comfort item, with embedded guidance through a dedicated website
- Population
- Children aged 7-12 years globally, recruited through online and offline strategies
Key finding
139 children were randomized to the REST trial, with 73% (n=101) completing outcome surveys
S et al. · Europe PMC · 28 Aug 2026