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

Sponsor
Halmstad University
Study ID
NCT06808425
Status
Recruiting
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Conditions

  • ADHD
  • Sleep
  • Sleep Disturbances
  • Sleep Problems

Eligibility Criteria

Sex
ALL
Age
6 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

  • Intervention A — DEVICE
    Weighted blanket
  • Intervention B — DRUG
    Standard treatment (melatonin)

Study Details

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.

Key Dates

First listed
Feb 5, 2025
Start date
Feb 3, 2025
Status verified
Jan 2025
Primary completion
Feb 28, 2034
Completion
Feb 28, 2034

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Weighted blanket
  • Active Comparator: Standard treatment (melatonin)

Primary Outcome Measure

Insomnia Severity Index (ISI) [ Time Frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years ]

Central Contacts

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