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
Abstract
Sleep is essential for childrens health and development, yet sleep problems are common worldwide. Comfort items such as soft toys or blankets are widely used to promote independent sleep, but their effects have not been evaluated in a randomised controlled trial (RCT). The REST trial emerged from a child-led citizen-science study (The Kids Trial) where children co-created and designed the trial. Therefore, this paper had two aims, to assess whether sleeping with a comfort item affected childrens sleep; and to assess the feasibility of conducting an online, child-led citizen-science RCT. The REST (Randomised Evaluation of Sleeping with a Toy or comfort item) trial was an online two-arm, parallel-group, superiority RCT. Children, aged 7 to 12 years, were randomised (1:1) to either sleep with a self-chosen comfort item ( Try-it-Out group) or refrain from using one ("Wait-and-See" group) for one week. The primary outcome was sleep-related impairment (SRI; PROMIS Pediatric Short Form v1.0 SRI 4a). The secondary outcome was overall sleep quality (Single Item Sleep Quality Scale, SQS). Analyses followed an intention-to-treat principle using mixed-effects models adjusted for baseline measures. A total of 139 children from 11 countries were randomised (mean age: 9.8 years; 45% female); 101 children (73%) completed post-test measures at one week. The adjusted mean difference (Intervention minus Control) in SRI T-scores was -0.53 (95% CI: -3.40 to 2.34; p = 0.714), equivalent to…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 139 participants or records.
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