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

NCT06808425 | Recruiting

• 1 other identifier: F2024/38
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD; Sleep Disturbances; Sleep; Sleep Problems

Keywords

implementation; sleep intervention; weighted blankets; children with ADHD; sleep problems

Outcome Measures

Primary Outcomes (4)

• Insomnia Severity Index (ISI)

  Insomnia Severity Index (ISI) assesses insomnia in the past two weeks by seven questions encompassing difficulties with 1) Sleep onset, 2) Sleep maintenance, and 3) Early morning awakening, as well as 4) Satisfaction with current sleep pattern, 5) Interference with daily functioning, 6) Noticeability of impairment attributed to the sleep problem, and 7) Level of distress caused by the sleep problem. Each question is assessed by a Likert scale. The answers is summed into a total score where a higher score indicates greater problems with insomnia.

  Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years

• Pediatric Insomnia Severity Index (PISI)

  Pediatric Insomnia Severity Index (PISI) is a parent-reported questionnaire assessing insomnia during the past week in children by six questions encompassing difficulties with 1) Sleep onset delay, 2) Sleep onset, 3) Nightly awakenings, 4) Falling back to sleep after nightly awakenings, 5) Daytime sleepiness, and 6) Sleep duration. The parents rate the frequency of sleep problems on scales, and the severity of sleep problems is summed into a total score, where a higher score indicates a greater degree of sleep problems.

  Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years

• Children's Sleep Habits Questionnaire (CSHQ)

  Children's Sleep Habits Questionnaire (CSHQ) - Swedish version (CSHQ-SWE) is a parent-reported questionnaire assessing sleep during the past week in children by 33 questions. The frequency of sleep problems or sleepiness during various activities for each question is estimated. The questions are divided into eight dimensions: 1) Bedtime resistance, 2) Sleep onset delay 3) Sleep duration, 4) Sleep anxiety, 5) Night wakings, 6) Parasomnias, 7) Sleep disordered breathing, and 8) Daytime sleepiness. The severity of sleep problems is summed into a total score, where a higher score indicates a greater degree of sleep problems.

  Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years

• Sleep Self Report (SSR)

  Sleep Self Report (SSR)2 is a questionnaire that assesses sleep-related difficulties with a focus on bedtime, sleep behavior and daytime sleepiness. The SSR contains 26 questions, of which 23 of the questions are answered by estimating frequency of events, and the remaining three questions are non-scored inquiries. The total score is summed up, with a higher score indicating more sleep problems.

  Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years

Secondary Outcomes (13)

• Child Outcome Rating Scale (CORS)

  Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years

• Outcome Rating Scale (ORS)

  Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years

• Work and Social Adjustment Scale, Youth version (WSAS-Y)

  Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years

• Work and Social Adjustment Scale, Parent version (WSAS-P)

  Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years

• The Brief Child and Family Phone Interview (BCFPI)

  Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years

Other Outcomes (3)

• Usage of weighted blanket and/or melatonin

  Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years

• Interviews with children and parents

  6 months and 1 year

• Interviews with clinical staff

  6 months and 1 year

Study Arms (2)

Weighted blanket

ACTIVE COMPARATOR

Device: Intervention A

Standard treatment (melatonin)

ACTIVE COMPARATOR

Drug: Intervention B

Interventions

Intervention A DEVICE

Weighted blanket

Weighted blanket

Intervention B DRUG

Standard treatment (melatonin)

Standard treatment (melatonin)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Halmstad University: lead

Study Sites (1)

Halmstad University

Halmstad, Halland County, 30118, Sweden

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Parasomnias

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Lena-Karin Erlandsson, PhD

CONTACT

0046729773818; lena-karin.erlandsson@hh.se

Ingrid Larsson, PhD

CONTACT

0046729773722; ingrid.larsson@hh.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 5, 2025
• Study Start: February 3, 2025
• Primary Completion (Estimated): February 1, 2034
• Study Completion (Estimated): February 1, 2034
• Last Updated: March 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)