NCT04180189

An Intervention With Weighted Blankets for Children With ADHD and Sleep Problems

SLEEP - An Intervention With Weighted Blankets for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Sleep Problems

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Halmstad University · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate a sleep intervention with weighted blankets for children with ADHD and sleep problem regarding health-related outcomes, sleep, and cost-effectiveness. The study is an RCT with cross-over design. The participants will be randomized to start with an active or placebo blanket, and then change blankets during the 16 week study period.

Detailed description

There is limited evidence about health outcomes or health-economic benefits of sleep interventions with weighted blankets for children with neuropsychiatric syndromes (NPS). The aim of the study is to evaluate a sleep intervention with weighted blankets for children with ADHD and sleep problem regarding health-related outcomes, sleep, and cost-effectiveness. The participants, n=100 children between 6 and 13 years old, will be recruited from the ADHD unit in Child and Adolescent Mental Health Service (CAMHS) and randomly assigned into two groups: Fiber Weighted Blankets (intervention 1) and Control Blankets (controls). The children will use each blanket respectively for 4 weeks, then change blankets. A long term follow-up will be conducted 16 weeks from baseline.

Conditions

• Adhd
• Sleep Disturbance

Interventions

Type	Name	Description
OTHER	Weighted fiber blanket	Using weighted blanket for four weeks

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2019-11-27
• Last updated: 2023-03-01

Locations

1 site across 1 country: Sweden