Actively Recruiting
Intervention With Weighted Blankets for Children With ADHD and Sleep Problems: Implementation and Effectiveness
Led by Halmstad University · Updated on 2025-03-14
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of weighted blankets as a sleep intervention for children aged 6 to 14 years with ADHD and sleep problems. The study compares the short- and long-term effects of weighted blankets to the standard treatment with melatonin. It also explores the barriers and facilitators to using weighted blankets in daily clinical practice and assesses related health-economic outcomes. Participants receive either a weighted blanket or standard melatonin treatment as part of the study. The trial is non-randomized and compares these two active treatments to understand their impact on sleep and health over time. The treatments are assessed at multiple time points including baseline, 1 month, 3 months, 6 months, 1 year, and then yearly for up to 10 years. During the study, children will complete several assessments including the Insomnia Severity Index, Pediatric Insomnia Severity Index, Children's Sleep Habits Questionnaire, and Sleep Self Report, among others. Secondary outcomes include measures of child and family well-being, anxiety, ADHD symptoms, quality of life, pain, costs related to psychiatric care, school attendance, and healthcare visits. These evaluations occur regularly from baseline through long-term follow-up to monitor effects and safety.
CONDITIONS
Brief Title
Intervention With Weighted Blankets for Children With ADHD and Sleep Problems: Implementation and Effectiveness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children diagnosed with ADHD (DSM-5) and sleep problems defined by a screening tool
- Being a patient at child and adolescent mental health service (CAMHS) in Region Halland, Sweden
- Age between 6 and 14 years
You will not qualify if you...
- Not explicitly stated in the source data; no known exclusion criteria provided
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either a weighted blanket or standard treatment with melatonin to manage sleep problems associated with ADHD.
Visits at baseline, 1 month, 3 months, and 6 months
Duration - Up to 9 years
Participants are followed yearly for ongoing assessment of sleep and ADHD symptoms for up to 9 additional years after treatment.
Annual visits
Trial Site Locations
Total: 1 location
1
Halmstad University
Halmstad, Halland County, Sweden, 30118
Actively Recruiting
Research Team
L
Lena-Karin Erlandsson, PhD
I
Ingrid Larsson, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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