Intervention with Weighted Blankets for Children with ADHD and Sleep Problems: Implementation and Effectiveness

Halmstad University

Status: Enrolling

Conditions: Sleep Problems; ADHD; Sleep Disturbances; Sleep

Treatments: Device: Intervention A; Drug: Intervention B

Study type: Interventional

Funder types: Other

Identifiers

NCT06808425

F2024/38

Details and patient eligibility

About

The aim is to study a sleep intervention with weighted blankets in children with ADHD and sleep problems regarding 1) short- and long-term effects on sleep and health-related outcomes in comparison with standard treatment (melatonin), 2) barriers and facilitators to implementation in routine clinical practice, and 3) health-economic outcomes.

Enrollment: 200 estimated patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Children diagnosed with ADHD (DSM-5) and sleep problems (defined by screening instrument).
• Being a patient at child and adolescent mental health service (CAMHS) in Region Halland, Sweden.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Weighted blanket

Active Comparator group

Treatment:

Device: Intervention A

Standard treatment (melatonin)

Active Comparator group

Treatment:

Drug: Intervention B