Study of Weighted Blankets Versus Melatonin for Improving Sleep in Children Ages 6 to 14 With ADHD and Sleep Problems

What this Trial Is About

Researchers are evaluating the use of weighted blankets as a sleep intervention for children aged 6 to 14 years with ADHD and sleep problems. The study compares the short- and long-term effects of weighted blankets to the standard treatment with melatonin. It also explores the barriers and facilitators to using weighted blankets in daily clinical practice and assesses related health-economic outcomes. Participants receive either a weighted blanket or standard melatonin treatment as part of the study. The trial is non-randomized and compares these two active treatments to understand their impact on sleep and health over time. The treatments are assessed at multiple time points including baseline, 1 month, 3 months, 6 months, 1 year, and then yearly for up to 10 years. During the study, children will complete several assessments including the Insomnia Severity Index, Pediatric Insomnia Severity Index, Childrens Sleep Habits Questionnaire, and Sleep Self Report, among others. Secondary outcomes include measures of child and family well-being, anxiety, ADHD symptoms, quality of life, pain, costs related to psychiatric care, school attendance, and healthcare visits. These evaluations occur regularly from baseline through long-term follow-up to monitor effects and safety.

Intervention With Weighted Blankets for Children With ADHD and Sleep Problems: Implementation and Effectiveness