340
Participants
Start Date
January 1, 2024
Primary Completion Date
April 15, 2026
Study Completion Date
August 1, 2028
Weighted blanket
"The intervention group will receive a weighted blanket classified as a medical device class 1 as an add on to usual treatment. Participants will be asked to choose one out of at least three different weighted blankets, each with different weight classes. The choice of weighted blanket is solely taken by the participant after having tried all five blankets.~Adherence to the weighted blanket intervention is defined as reported use 60 % of the intervention period.~Usual treatment as part of standard care for children with ADHD, which can consist of sleep hygiene, psychoeducation, cognitive behavioral theory, medications such as melatonin or ADHD medication."
Non-weighted blanket
"The control comparator will receive a sham intervention in the form of a non-weighted blanket as an add on to usual care. Participants will be asked to choose one out of two different sham blankets.~Usual treatment as part of standard care for children with ADHD, which can consist of sleep hygiene, psychoeducation, cognitive behavioral theory, medications such as melatonin or ADHD medication."
RECRUITING
The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg
Mental Health Services in the Capital Region, Denmark
OTHER
University Hospital Bispebjerg and Frederiksberg
OTHER