Clinical trial NCT04180189: An Intervention With Weighted Blankets for Children With ADHD and Sleep Problems
Official title: SLEEP - An Intervention With Weighted Blankets for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Sleep Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhd
Sleep Disturbance
Keywords: children
non-pharmacological intervention
ADHD
sleep
Lead sponsor: Halmstad University
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Children diagnosed with ADHD with sleep problems (defined by screening instrument). -
* 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:

* Already used weighted blankets as a sleep intervention,
* If they have received a new prescription or change of pharmacological treatment for sleep problems

Primary outcomes:
measure: Sleep efficiency
timeFrame: 1 week
measure: Sleep onset latency
timeFrame: 1 week
measure: Wake after sleep onset
timeFrame: 1 week
measure: Total sleep time
timeFrame: 1 week
measure: Self-reported sleep (Parental reported)
timeFrame: 1 week
measure: Self-reported sleep
timeFrame: 1 week
Secondary outcomes:
measure: Parents' Health related quality of life
timeFrame: 1 day
measure: Children's Health related quality of life
timeFrame: 1 day
measure: Children's general well-being
timeFrame: 1 day
measure: Parent general well-being
timeFrame: 1 day
measure: Anxiety
timeFrame: 1 day
measure: ADHD symptoms
timeFrame: 1 week
measure: Family situation and parental mood
timeFrame: 1 week
measure: Cost effectiveness
timeFrame: 4 week
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: Halmstad University
Study officials:
affiliation: Halmstad University
name: Ingrid Larsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.