Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • ADHD
  • Sleep Disturbance
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Double (Participant, Care Provider)Primary Purpose: Treatment

Participation Requirements

Age
Between 6 years and 18 years
Gender
Both males and females

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 regar...

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=80 children between 6 and 15 years old, will be recruited from the ADHD unit in DCAP (Department of Child and Adolescent Psychiatry) 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.

Tracking Information

NCT #
NCT04180189
Collaborators
Not Provided
Investigators
Principal Investigator: Ingrid Larsson, PhD Halmstad University