Peer-reviewed article
Online randomised trials with children: A scoping review
Simone Lepage, Aislinn Conway, Noah Goodson, Paul J Wicks, Laura Flight et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This scoping review examines how online randomised trials with children under 18 have been designed and conducted. The authors identified 21 trials and described their methods, including recruitment approaches, data storage, trial duration, and participant compensation. The review found significant gaps in transparent reporting of recruitment, randomisation, and retention methods, as well as limited involvement of children in trial design.
Key points
- 21 online randomised trials with children (average age 14.6 years) met inclusion criteria
- Social media was the most common recruitment method; external host websites were used for data storage in most trials
- Trial duration ranged from single-session interventions to ten weeks; 14 trials compensated participants
- High risk of bias found in blinding of participants, personnel, and outcome assessors; allocation concealment was often unclear
- Patient and public involvement in trial design occurred in only 8 trials, with no compensation reported for involvement
Limitations
This is a methodological review of trial conduct rather than an evaluation of child health or well-being outcomes. It does not assess the effectiveness of any interventions tested within these trials, nor does it examine impacts on children's actual health, development, protection, or participation outcomes.
Abstract
Abstract Background Paediatric trials must contend with many challenges that adult trials face but often bring additional obstacles. Decentralised trials, where some or all trial methods occur away from a centralised location, are a promising strategy to help meet these challenges. This scoping review aims to (a) identify what methods and tools have been used to create and conduct entirely online-decentralised trials with children and (b) determine the gaps in the knowledge in this field. This review will describe the methods used in these trials to identify their facilitators and the gaps in the knowledge. Methods The methods were informed by guidance from the Joanna Briggs Institute and the PRISMA extension for scoping reviews. We systematically searched MEDLINE, CENTRAL, CINAHL, and Embase databases, trial registries, pre-print servers, and the internet. We included randomised and quasi-randomised trials conducted entirely online with participants under 18 published in English. A risk of bias assessment was completed for all included studies. Results Twenty-one trials met our inclusion criteria. The average age of participants was 14.6 years. Social media was the most common method of online recruitment. Most trials employed an external host website to store and protect their data. Duration of trials ranged from single-session interventions up to ten weeks. Fourteen trials compensated participants. Eight trials involved children in their trial design process; none reported compensation for this. Most trials had a low risk of bias in “random sequence generation”, “selective reporting”, and “other”. Most trials had a high risk of bias in “blinding participants and personnel”, “blinding of outcome assessment”, and “incomplete outcome data”. “Allocation concealment” was unclear in most studies. Conclusions There was a lack of transparent reporting of the recruitment, randomisation, and retention methods used in many of the trials included in this review. Patient and public involvement (PPI) was not common, and the compensation of PPI partners was not reported in any study. Consent methods and protection against fraudulent entries to trials were creative and thoroughly discussed by some trials and not addressed by others. More work and thorough reporting of how these trials are conducted is needed to increase their reproducibility and quality. Ethics and Dissemination Ethical approval was not necessary since all data sources used are publicly available.