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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep; ADHD; Sleep Problems; Sleep Disturbances
• Intervention / Treatment: Device: Intervention A; Drug: Intervention B

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lena-Karin Erlandsson, PhD; Phone Number: 0046729773818; Email: lena-karin.erlandsson@hh.se
• Study Contact Backup: Name: Ingrid Larsson, PhD; Phone Number: 0046729773722; Email: ingrid.larsson@hh.se

Study Locations

• Sweden
  • Halland
    • Halmstad, Halland, Sweden, 30118
      • Recruiting
      • Halmstad University
      • Contact: Ingrid Larsson, PhD; Phone Number: 0046729773722; Email: ingrid.larsson@hh.se
      • Contact: Julia S Malmborg, PhD; Phone Number: 0046721784979; Email: julia.soderstrom_malmborg@hh.se
      • Contact: Ingrid Larsson, PhD
      • Contact: Julia S Malmborg, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Weighted blanket	Device: Intervention A; Weighted blanket
Active Comparator: Standard treatment (melatonin)	Drug: Intervention B; Standard treatment (melatonin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Outcome Rating Scale (CORS)	Child Outcome Rating Scale (CORS) assesses everyday function and well-being in the domains of individual, family, school, and overall. Each domain is rated by the child on visual analogue scales, scored worst-best. A total score will also be utilized.	Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
Outcome Rating Scale (ORS)	assesses everyday function and well-being in the domains of individual, interpersonal, social role, and overall. Each domain is rated by the adult on visual analogue scales, scored worst-best. A total score will also be utilized.	Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
Work and Social Adjustment Scale, Youth version (WSAS-Y)	Work and Social Adjustment Scale, Youth version (WSAS-Y) assesses children's daily functioning. The instrument consists of five questions where children estimate the extent to which their problems affect school, daily skills, social activities, hobbies, and family and relationships. A total score is obtained, with higher scores indicating greater impact.	Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
Work and Social Adjustment Scale, Parent version (WSAS-P)	Work and Social Adjustment Scale, Parent version (WSAS-P) assesses children's daily functioning. The instrument consists of five questions where parents estimate the extent to which the children's problems affects school, daily skills, social activities, hobbies, and family and relationships. A total score is obtained, with higher scores indicating greater impact.	Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
The Brief Child and Family Phone Interview (BCFPI)	The Brief Child and Family Phone Interview (BCFPI) is a screening tool used to assess everyday functioning in children with neurodevelopmental conditions, as well as everyday functioning in the family. Selected scales from BCFPI will be utilized: "Impact on child functioning" (social participation, quality of social relations, and school participation and achievement), "Impact on family functioning" (family activities and family comfort), and "Parental functioning" (appetite problems, concentration problems, and emotional problems).	Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
Lifestyle habits	The child's height and weight, dietary habits (fruit intake, vegetable intake, consumption of sweets, and consumption of sugar-sweetened beverages), physical activity (fulfilling of recommendations, frequency of exercise during leisure time, and time spent on exercise during leisure time) and screen time and sedentary time (time spent in front of screen-based entertainment, time spent in sedentary gaming, and time spent using electronic devices for other purposes) are estimated by parents by selected questions included in the Health Behaviour in School-aged Children (HBSC) survey carried out by the Public Health Agency of Sweden.	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)	The State-Trait Anxiety Inventory Scale - short form (Short STAI) assesses anxiety in children by six questions encompassing the themes of Calm, Tense, Upset, Relaxed, Content, and Worried. Each question is rated by the child, and the total score (best-worst) is obtained.	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)	The Swanson, Nolan, and Pelham Scale - parent-reported version (SNAP-IV parent) assesses ADHD symptoms and Oppositional Defiant Disorder (ODD) symptoms. The questionnaire includes 30 questions rated by the parent on a Likert scale. Attention deficit is covered by nine items, hyperactivity and impulsivity are combined and covered by nine items, and ODD is covered by eight items.The average rating per item may be calculated for the scales of attention deficit, hyperactivity and impulsivity, attention deficit/hyperactivity/impulsivity combined, and ODD. The additional four items are supplementary to ADHD (two items) and ODD (two items) and are not included in scoring. A higher score reflects greater severity of symptoms.	Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
EQ-5D-Y-3L	EQ-5D-Y-3L assesses health-related quality of life in children and adolescents. The questionnaire covers five domains: mobility, looking after myself, doing usual activities, having pain or discomfort, and feeling worried, sad or unhappy. Each domain is rated by the child on a Likert scale and answers are calculated into an index (worst-best). The questionnaire also includes a visual analogue scale (worst-best), reflecting current health state.	Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
EQ-5D-3L	EQ-5D-3L assesses health-related quality of life in adults. The questionnaire covers five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated by the parent on a Likert scale and answers are calculated into an index (worst-best). The questionnaire also includes a visual analogue scale (worst-best), reflecting current health state.	Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
Treatment Inventory Cost in Psychiatric Patients (TIC-P)	Selected items from the Treatment Inventory Cost in Psychiatric Patients (TIC-P) will be utilized. TIC-P is a questionnaire that assesses absence from work and changes in work productivity for parents.	Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
School absence and healthcare visits	Parents will be asked to specify number of days their child has been absent from school and number of healthcare visits (specified by healthcare provider and healthcare professional) their child has made during the preceding month.	Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
Pain intensity	Pain intensity during the last week is assessed by a visual analogue scale. The child estimates their perceived pain intensity during the last week on a scale between 0-100, where 0 corresponds to "no pain" and 100 corresponds to "worst imaginable pain".	Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usage of weighted blanket and/or melatonin	Parents will report frequency of usage of weighted blanket and/or melatonin on a 4-point scale (every night = 6-7 nights a week; almost every night = 4-5 nights a week; sometimes = 2-3 nights a week; almost never = 0-1 night a week). An additional three open-ended questions concerning how weighted blankets and/or melatonin have been used, the reason for usage, and thoughts about usage will be utilized.	Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
Interviews with children and parents	Individual interviews will be carried out with children and parents concerning the implementation of the intervention and the effect of the intervention, as well as how sleep affects child's everyday functioning, everyday activities, worry and anxiety, ADHD-related symptom burden, health-related quality of life, and sensory impressions.	6 months and 1 year
Interviews with clinical staff	Individual interviews and/or focus group interviews will be carried out with clinical staff concerning the implementation of the intervention.	6 months and 1 year

Collaborators and Investigators

• Sponsor: Halmstad University

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): February 1, 2034
• Study Completion (Estimated): February 1, 2034

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: implementation; weighted blankets; sleep problems; sleep intervention; children with ADHD
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Dyssomnias; Parasomnias; Body Weight; Sleep Wake Disorders
• Other Study ID Numbers: F2024/38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No