ADHDNCT06808425
Intervention With Weighted Blankets for Children With ADHD and Sleep Problems: Implementation and Effectiveness
A study testing Intervention A and Intervention B in people with ADHD and Sleep Disturbances, run by Halmstad University at 1 site in Sweden.
Trial 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)… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- ADHD, Sleep Disturbances, Sleep
- What is being tested?
- Intervention A and Intervention B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 3 Feb 2025to Feb 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Halmstad University
Halmstad, Halland County, 30118
Ingrid Larsson, PhD, 0046729773722, ingrid.larsson@hh.se
Julia S Malmborg, PhD, 0046721784979, julia.soderstrom_malmborg@hh.se
About this study
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
- Being tested
- Intervention A, Intervention B
- Keywords
- implementation, sleep intervention, weighted blankets, children with ADHD, sleep problems
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ADevice
Weighted blanket
Intervention BDrug
Standard treatment (melatonin)
| Study group | Role | What they receive |
|---|---|---|
| Weighted blanket | Active comparator | Not described Receives: Device: Intervention A |
| Standard treatment (melatonin) | Active comparator | Not described Receives: Drug: Intervention B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start3 Feb 2025
- Primary completionFeb 2034 (estimated)
- Study completionFeb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halmstad University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingrid Larsson, RN, PhD, Professor, Halmstad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808425
- Sponsor's protocol ID
- F2024/38
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larsson I, Svedberg P, Jarbin H, Nygren J, Lindholm A, Aili K, Malmborg JS. Implementation and real-world effectiveness of a weighted blanket intervention and standard melatonin treatment for children with ADHD and sleep problems: protocol for a pragmatic longitudinal cohort study. BMC Psychiatry. 2026 Aug 25;26(1):665. doi: 10.1186/s12888-026-08538-4.
PubMed 42642740
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention With Weighted Blankets for Children With ADHD and Sleep Problems: Implementation and Effectiveness
- ClinicalTrials.gov ID
- NCT06808425
- Acronym / sponsor ID
- F2024/38
- Conditions
- ADHD, Sleep Disturbances, Sleep, Sleep Problems
- Keywords
- implementation, sleep intervention, weighted blankets, children with ADHD, sleep problems
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Halmstad UniversityUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Feb 2034 (estimated)
- Study completion
- Feb 2034 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weighted blanket | Active comparator | Device: Intervention A |
| Standard treatment (melatonin) | Active comparator | Drug: Intervention B |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention AWeighted blanket | Device | Weighted blanket |
| Intervention BStandard treatment (melatonin) | Drug | Standard treatment (melatonin) |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
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.
Pediatric Insomnia Severity Index (PISI)
Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
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.
Children's Sleep Habits Questionnaire (CSHQ)
Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
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.
Sleep Self Report (SSR)
Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
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.
13 secondary outcomes
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
School absence and healthcare visits
Time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Derived from this study: PubMed 42642740Larsson I, Svedberg P, Jarbin H, Nygren J, Lindholm A, Aili K, Malmborg JS. Implementation and real-world effectiveness of a weighted blanket intervention and standard melatonin treatment for children with ADHD and sleep problems: protocol for a pragmatic longitudinal cohort study. BMC Psychiatry. 2026 Aug 25;26(1):665. doi: 10.1186/s12888-026-08538-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention A and Intervention B in people with ADHD and Sleep Disturbances, run by Halmstad University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lena-Karin Erlandsson, PhD (0046729773818, lena-karin.erlandsson@hh.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06808425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.