Clinical trial NCT06808425: Intervention With Weighted Blankets for Children With ADHD and Sleep Problems: Implementation and Effectiveness
Official title: Intervention With Weighted Blankets for Children With ADHD and Sleep Problems: Implementation and Effectiveness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Sleep Disturbances
Sleep
Sleep Problems
Keywords: implementation
sleep intervention
weighted blankets
children with ADHD
sleep problems
Lead sponsor: Halmstad University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: Pediatric Insomnia Severity Index (PISI)
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: Sleep Self Report (SSR)
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
Secondary outcomes:
measure: Child Outcome Rating Scale (CORS)
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: Outcome Rating Scale (ORS)
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: Work and Social Adjustment Scale, Youth version (WSAS-Y)
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: Work and Social Adjustment Scale, Parent version (WSAS-P)
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: The Brief Child and Family Phone Interview (BCFPI)
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: Lifestyle habits
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: The State-Trait Anxiety Inventory Scale - short form (Short STAI)
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: The Swanson, Nolan, and Pelham Scale - parent-reported version (SNAP-IV parent)
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: EQ-5D-Y-3L
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: EQ-5D-3L
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: Pain intensity
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: Treatment Inventory Cost in Psychiatric Patients (TIC-P)
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: School absence and healthcare visits
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
Other outcomes:
measure: Usage of weighted blanket and/or melatonin
timeFrame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
measure: Interviews with children and parents
timeFrame: 6 months and 1 year
measure: Interviews with clinical staff
timeFrame: 6 months and 1 year
Locations:
city: Halmstad
country: Sweden
facility: Halmstad University
state: Halland
Study officials:
References: