An Intervention With Weighted Blankets for Children With ADHD and Sleep Problems
NCT ID: NCT04180189
Last Updated: 2023-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2020-01-01
2022-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Weighted fiber blanket
Using a weighted blanket
Weighted fiber blanket
Using weighted blanket for four weeks
Regular fiber blanket
Using a specially designed fiber blanket without extra weight.
Weighted fiber blanket
Using weighted blanket for four weeks
Interventions
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Weighted fiber blanket
Using weighted blanket for four weeks
Eligibility Criteria
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Inclusion Criteria
* Being a patient at child and adolescent mental health service (CAMHS) in Region Halland, Sweden.
* Parents and children should understand (written and spoken) Swedish language.
Exclusion Criteria
* If they have received a new prescription or change of pharmacological treatment for sleep problems
6 Years
13 Years
ALL
No
Sponsors
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Halmstad University
OTHER
Responsible Party
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Ingrid Larsson, RN, PhD, Associated Professor
RN, PhD, Associate professor
Principal Investigators
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Ingrid Larsson, PhD
Role: PRINCIPAL_INVESTIGATOR
Halmstad University
Locations
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Halmstad University
Halmstad, , Sweden
Countries
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References
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Larsson I, Aili K, Nygren JM, Johansson P, Jarbin H, Svedberg P. SLEEP: intervention with weighted blankets for children with attention deficit hyperactivity disorder (ADHD) and sleep problems: study protocol for a randomised control trial. BMJ Open. 2022 Jan 4;12(1):e047509. doi: 10.1136/bmjopen-2020-047509.
Other Identifiers
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1SLEEP
Identifier Type: -
Identifier Source: org_study_id
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