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Recruiting NCT06808425

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

No phase Interventional ADHD Sleep Disturbances Sleep Sleep Problems

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention A, Intervention B.
Who it may be relevant to
Registry conditions: ADHD, Sleep Disturbances, Sleep, Sleep Problems. Basic parameters: 6 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Intervention A
    Weighted blanket
  • Drug Intervention B
    Standard treatment (melatonin)

Primary outcome measures

  • Insomnia Severity Index (ISI) [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]
  • Pediatric Insomnia Severity Index (PISI) [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]
  • Children's Sleep Habits Questionnaire (CSHQ) [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]
  • Sleep Self Report (SSR) [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]
Secondary outcome measures (12)
  • Child Outcome Rating Scale (CORS) [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]
  • Outcome Rating Scale (ORS) [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]
  • Work and Social Adjustment Scale, Youth version (WSAS-Y) [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]
  • Work and Social Adjustment Scale, Parent version (WSAS-P) [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]
  • The Brief Child and Family Phone Interview (BCFPI) [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]
  • Lifestyle habits [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]
  • The State-Trait Anxiety Inventory Scale - short form (Short STAI) [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]
  • The Swanson, Nolan, and Pelham Scale - parent-reported version (SNAP-IV parent) [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]
  • EQ-5D-Y-3L [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]
  • EQ-5D-3L [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]
  • Pain intensity [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]
  • Treatment Inventory Cost in Psychiatric Patients (TIC-P) [Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Halmstad University — Halmstad

Identifiers

NCT: NCT06808425 · F2024/38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗