The Kid's Trial: On online, randomised trial co-created with 7- to 12-year-old children.

Introduction Health literacy – the ability to access, understand, appraise, and use health information – is essential for making informed decisions about health and healthcare. Developing health literacy early in life is critical, as the reasoning and evaluative skills formed during childhood shape how people interpret evidence and make decisions as adults. A key component of health literacy is understanding how randomised controlled trials (RCTs) generate reliable evidence about the effectiveness of health interventions. Without this understanding, individuals are less able to evaluate the credibility of health information regarding claims about the effects of health interventions or to recognise the value of participating in research. Greater public understanding of trials, in turn, fosters trust in science, encourages participation, and strengthens the inclusivity and efficiency of research, thereby helping reduce research waste and improve the evidence base on which health research depends. In an era when the public is inundated with health claims, building trial literacy and critical thinking from an early age is a crucial public health priority. This thesis presents The Kid’s Trial, a fully online, child-led citizen-science study for 7- to 12-year-olds designed to help children understand RCTs through hands-on participation. The project mirrors the key phases of a clinical trial and culminates in an embedded RCT (the REST trial). By engaging children as co-designers and participants, The Kid’s Trial makes evidence generation, including randomisation and fair comparisons, concrete and meaningful. Grounded in a participatory approach, it positions children as active contributors rather than passive subjects. The aims were to help children understand what RCTs are, why they are important, and how to think critically about health claims. Methodologically, the thesis tests whether core trial principles can be upheld within a decentralised design; ethically, it operationalises meaningful child participation; and educationally, it explores how experiential engagement with research processes may help foster trial literacy and critical thinking. Methods The thesis comprises eight chapters (inclusive of six papers) that collectively advance participatory methods for involving children in decentralised RCTs. The research progressed through three stages: a scoping review to identify existing methods and gaps; participatory design with children to co-create The Kid’s Trial; and implementation and evaluation of the embedded REST trial. Papers 1–2 report the protocol (published) and completed scoping review of online RCTs with children. Following Joanna Briggs Institute and PRISMA-ScR guidance, systematic searches of MEDLINE, CENTRAL, CINAHL, Embase, trial registries, preprint servers, and grey literature identified randomised and quasi-randomised trials conducted entirely online with children. The review established the methodological foundation for later stages. Paper 3 (published) describes the development and facilitation of two online patient and public involvement (PPI) groups of children and parents who contributed to the co-design of The Kid’s Trial. Semi-structured interviews and reflexive thematic analysis explored PPI members’ experiences and identified mechanisms that supported meaningful online engagement. Paper 4 (under review) details the design and implementation of The Kid’s Trial, in which children took part in five steps: generating a research question, designing the trial, taking part in the embedded RCT, submitting results, and deciding how the findings would be shared. Feasibility and engagement were described and assessed to identify and interpret participation patterns and logistical challenges. Papers 5 (accepted for publication) and 6 (under review) present the protocol and results of the embedded REST (Randomised Evaluation of Sleeping with a Toy or Comfort Item) trial. The protocol pre-specified the target sample size, outcomes, intervention and control conditions, and statistical analysis plan. The trial randomised children aged 7 to 12 years to sleep with or without a comfort item for one week. Self-reported sleep-related impairment and sleep quality were analysed using mixed-effects models adjusted for baseline measures under the intention-to-treat principle. Results The scoping review (Papers 1–2) identified 21 fully online randomised or quasi-randomised trials from 6,957 screened records. Recruitment through social media often led to rapid enrolment, but descriptions of recruitment and retention strategies were generally limited, and no studies included cost analyses. Consent procedures were well described with innovative online tools to assess comprehension and minimise fraudulent entries. PPI was reported rarely, and no studies described contributor compensation. These gaps informed the design of The Kid’s Trial. Paper 3 confirmed the feasibility of online PPI with children and parents through two advisory groups (CRAG and PRAG). Despite recruitment and scheduling challenges, sustained engagement was achieved through flexible communication, inclusive facilitation, and age-appropriate materials. PPI members refined consent materials, simplified language, and co-developed child-friendly website content, ensuring the study was accessible, engaging, and ethically sound. These insights directly informed the development and implementation of The Kid’s Trial. Paper 4 detailed the implementation of The Kid’s Trial, in which 224 participants from 15 countries took part in at least one step. Children selected the research question, “Does sleeping with a comfort item (for example, a soft toy or special blanket) make a difference to how kids sleep compared with not sleeping with one?” They defined outcomes (sleep-related impairment and sleep quality), and designed the intervention and control conditions. Recruitment was most effective through schools and community partnerships, while paid social media advertising generated interest but not enrolment. Participation was highest during the trial-conduct phase. Engagement data indicated that children could understand and apply key RCT concepts, such as randomisation and fair comparison, when presented through accessible, interactive materials. The REST trial enrolled 139 children from 11 countries who were randomised (1:1) either to the control group (“Wait-and-See”), who abstained from sleeping with a comfort item, or the intervention group (“Try-it-Out”), who slept with one. Post-trial, 73% (n = 101) of participants submitted results. No significant treatment effect was observed for sleep-related impairment, and although there was a small, uncertain improvement in sleep quality, it was not sustained in sensitivity analyses. The REST trial did not reach its target sample size and was therefore underpowered, with 27% of participants lost to follow-up, further limiting the precision and interpretability of the findings. Despite these limitations, the REST trial demonstrated the feasibility of conducting a fully online, child-led RCT and offered important insights into participant engagement and retention, as well as the practical challenges of decentralised paediatric trial design. Conclusions This thesis demonstrates that children can meaningfully co-create and participate in fully decentralised RCTs when supported by participatory, developmentally appropriate methods. It shows that methodological rigour and participatory design are complementary requirements for ethical, child-centred research. The work contributes methodologically by documenting how core trial principles can be maintained within online, child-led frameworks; ethically, by translating children’s rights into sustained, rights-based co-creation; and educationally, by showing how experiential “learning-by-doing” can build trial literacy and critical thinking. Through The Kid’s Trial and its embedded REST trial, this research provides practical, replicable strategies for involving children in evidence generation, including early partnership with schools, online design, and transparent reporting of recruitment, retention, and PPI processes. Collectively, these findings reposition children from passive subjects to active contributors in research and lay a foundation for future participatory frameworks that integrate methodological integrity, ethics, and education in child-inclusive health research.

Funder

School of Nursing and Midwifery, University of Galway
Health Research Board

Publisher

University of Galway

Rights

CC BY-NC-ND

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Collections

University of Galway Theses (PhD Theses)