Weighted Blankets for Sleep Disturbance Among Children With ADHD

NARecruitingINTERVENTIONAL
Enrollment

340

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

April 15, 2026

Study Completion Date

August 1, 2028

Conditions
Attention-deficit HyperactivityAttention Deficit Hyperactivity DisorderNeurodevelopmental DisordersSleep DisturbanceAttention Deficit DisorderHyperkinetic Conduct DisorderAttention-Deficit Hyperactivity Disorder, Unspecified Type
Interventions
DEVICE

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."

DEVICE

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."

Trial Locations (1)

2000

RECRUITING

The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg

All Listed Sponsors
collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

lead

University Hospital Bispebjerg and Frederiksberg

OTHER