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

Halmstad University

Status: Completed

Conditions: Adhd; Sleep Disturbance

Treatments: Other: Weighted fiber blanket

Study type: Interventional

Funder types: Other

Identifiers

NCT04180189

1SLEEP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 6 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Weighted fiber blanket

Active Comparator group

Description:

Using a weighted blanket

Treatment:

Other: Weighted fiber blanket

Regular fiber blanket

Placebo Comparator group

Description:

Using a specially designed fiber blanket without extra weight.

Treatment:

Other: Weighted fiber blanket