Evaluation of health effects and cost effectiveness from a sleep intervention with weight blankets in children with ADHD and sleep problems

In October 2020, SKR´s Medical Technology Product Council (MTR-rådet) recommended all regions in Sweden to not subsidize prescribing of weight blankets due to insufficient evidence regarding the effectiveness of weight blankets.

To justify continuing prescribing weight blankets, more evidence is thus required from both randomized placebo-controlled and qualitative studies.AimThe overall aim is to evaluate a sleep intervention with weighted blankets for children aged 6–13-years with Attention Deficit Hyperactivity Disorder (ADHD) and sleep disorders.

Seven studies are carried out to explore the health effects and cost-effectiveness of the sleep intervention, as well as experiences from the children and parentsMethodDesignThe study is a randomized placebo-controlled intervention trial, with a cross-over designParticipantsThe population is 100 children aged 6–13 with newly diagnosed ADHD and sleep disordersInterventioThe children are randomized to begin either to use a weighted blanket or placebo blanket.

After 4 weeks, the participants switch to placebo blankets or weight blankets (cross-over design).Data collection study 1-2Data collection takes place at baseline, during weeks 4, 8, and 16 and at long-term follow-up after 1-year.

Sleep is measured objectively with an ActiGraph for 7 nights and questionnaires about sleep, the child´s function, ADHD symptoms, anxiety, medication, care contacts, school absence, and parents´ sick leave and work capacity.Data collection study 3A purposive sample of 25 children and 25 parents are interviewed after the intervention.Data analysisIn the RCT (study 1a, 1b), the effect of weight blankets is evaluated primarily concerning a change in sleep (objective and subjective).In the health economic study (study 2a, 2b), the cost-effectiveness of the sleep intervention with weighted blankets is analyzed compared with placebo.In the qualitative studies (study 3a, 3b, 3c), the interviews are analyzed with qualitative content analysis.