AdhdNCT04180189
An Intervention With Weighted Blankets for Children With ADHD and Sleep Problems
A study testing Weighted fiber blanket in people with Adhd and Sleep Disturbance, run by Halmstad University at 1 site in Sweden.
Trial summary
The aim of the study is to evaluate a sleep intervention with weighted blankets for children with ADHD and sleep problem regarding health-related outcomes, sleep, and cost-effectiveness. The study is an RCT with cross-over design. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Adhd, Sleep Disturbance
- What is being tested?
- Weighted fiber blanket
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with ADHD with sleep problems (defined by screening instrument). -
- Being a patient at child and adolescent mental health service (CAMHS) in Region Halland, Sweden.
- Parents and children should understand (written and spoken) Swedish language.
Who cannot join
- Already used weighted blankets as a sleep intervention,
- If they have received a new prescription or change of pharmacological treatment for sleep problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SLEEP - An Intervention With Weighted Blankets for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Sleep Problems
The aim of the study is to evaluate a sleep intervention with weighted blankets for children with ADHD and sleep problem regarding health-related outcomes, sleep, and cost-effectiveness.
The study is an RCT with cross-over design. The participants will be randomized to start with an active or placebo blanket, and then change blankets during the 16 week study period.
Read the detailed description
There is limited evidence about health outcomes or health-economic benefits of sleep interventions with weighted blankets for children with neuropsychiatric syndromes (NPS).
The aim of the study is to evaluate a sleep intervention with weighted blankets for children with ADHD and sleep problem regarding health-related outcomes, sleep, and cost-effectiveness.
The participants, n=100 children between 6 and 13 years old, will be recruited from the ADHD unit in Child and Adolescent Mental Health Service (CAMHS) and randomly assigned into two groups: Fiber Weighted Blankets (intervention 1) and Control Blankets (controls).
The children will use each blanket respectively for 4 weeks, then change blankets. A long term follow-up will be conducted 16 weeks from baseline.
- Conditions
- Adhd, Sleep Disturbance
- Being tested
- Weighted fiber blanket
- Keywords
- children, non-pharmacological intervention, ADHD, sleep
- 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.
Weighted fiber blanketOther
Using weighted blanket for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Weighted fiber blanket | Active comparator | Using a weighted blanket Receives: Other: Weighted fiber blanket |
| Regular fiber blanket | Placebo comparator | Using a specially designed fiber blanket without extra weight. Receives: Other: Weighted fiber blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency
objectively measured with actigraph during one week
Measured: 1 week
Sleep onset latency
objectively measured with actigraph during one week
Measured: 1 week
Wake after sleep onset
objectively measured with actigraph during one week
Measured: 1 week
Total sleep time
objectively measured with actigraph during one week
Measured: 1 week
Self-reported sleep (Parental reported)
Subjectively measured sleep problems in smaller children, assessed by Child's Sleep Habits Questionnaire (CSHQ), assessed by the parents, referring to last week. consists of 33 items related to eight subscales; 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. Each item is rated on a three-point scale: "usually" if the sleep behavior occurred five to seven times/week; "sometimes" for two to four times/week; and "rarely" for zero to one time/week. A higher score indicates more sleep problems
Measured: 1 week
Self-reported sleep
Subjectively measured sleep problems in children, assessed by Insomnia Severity Index (ISI), children responding, referring to last week, comprises seven items for the children to respond to: 1) Severity of sleep-onset, 2) Sleep maintenance, 3) Early morning awakening, 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 item is rated on a five-point Likert scale ranging from "not at all" (scored at 0) to "extremely" (scored at 4). Total score ranges from 0 to 28, with higher scores indicating greater severity.
Measured: 1 week
Secondary outcomes (8)
Parents' Health related quality of life
Assessed by EQ5D (among the parents), referring to this day. measuring the parents' health comprising five dimensions; 1) Mobility, 2) Self-care, 3) Usual activities, 4) Pain/discomfort, and 5) Anxiety/Depression. Each dimension is divided into three levels; No problems, Some or moderate problems, and extreme problems. In addition to the five dimensions, a 100-millimeter vertical Visual Analog Scale with endpoints of 100 means "best imaginable health state" and 0 means "worst imaginable health state is included. The total score ranges from 0 to 1 where a higher score indicates a better health-related quality of life.
Measured: 1 day
Children's Health related quality of life
Assessed by EQ5D-y (among the children), referring to this day, comprises five items; 1) Walking about (mobility), 2) Looking after myself (self-care), 3) Doing usual activities (usual activities), 4) Having pain or discomfort (pain and discomfort), and 5) Feeling worried, sad or unhappy (anxiety and depression). Each item is divided into three levels; No problems, Some problems, and A lot of problems. The EQ-5D-Y also includes an easily understandable modified vertical Visual Analogue Scale of EQ-5D, where the respondent rates the overall health status with the endpoints from 0 (the worst health state the child can imagine and 100 (the best health state the child can imagine)
Measured: 1 day
Children's general well-being
Assessed by Child Outcome Rating Scale (CORS), among the children, comprises four items where the child evaluates; 1) Me (How am I doing?), 2) Family (How are things in my family?), 3) School (How am I doing at school?), 4) Everything (How is everything going?). Each item is rated on a 100-millimeter Visual Analog Scale with smiling and sad faces as anchors.
Measured: 1 day
Parent general well-being
Assessed by Outcome Rating Scale (ORS), among the parents assessment of the past week in four items; 1) Personal wellbeing, 2) Interpersonal relationships, 3) Social relations and, 4) Overall sense of well-being. Each item is rated on a 100-millimeter Visual Analog Scale with anchors from 0 (negative) to 100 (positive).
Measured: 1 day
Anxiety
Assessed by short State-Trait Anxiety Inventory for children (short-STAI), includes six items.41 Each item is rated on a four-point Likert scale ranging with 1 = "not at all," 2 = "somewhat," 3, = "moderately", and 4 = "very much." The total score range from 6 to 24 points, with 6 points indicating no anxiety and 24 points indicating the highest level of anxiety.
Measured: 1 day
ADHD symptoms
Assessed by The Swanson, Peland, and Nolan Scale (SNAP-IV), consists of 30 items and is divided into three subscales: inattention (nine items), hyperactivity/impulsivity (nine items), and oppositionality (eight items) and four supplementary questions regarding oppositionality (two questions) and ADHD (two questions). Items are rated on a four-point Likert scale range 0 = "not at all", 1 = "just a little", 2 = "quite a bit", and 3 = "very much". Items for inattention and hyperactivity/impulsivity can be combined to create a "combined ADHD" score.43 Higher scores represent more symptoms.
Measured: 1 week
Family situation and parental mood
Assessed by Brief Child and Family Phone Interview (BCFPI), consists of 36 symptom items and another 36 items to assess function, adversity, and family stress grouped into 12 subscales. The subscale ´family situation' contains three items rated on a four-point Likert scale range 1 = never, 2 = sometimes, 3 = often, 4 =always. The subscale ´parental mood' contains six items based on the question "How often during the past week has the parent experienced…?" rated on a four-point scale; < 1 day, 1-2 days, 3-4 days, >5 days.
Measured: 1 week
Cost effectiveness
Assessed by health economic aspects, such as absence from work, productivity, contact with health-care last four weeks
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start1 Jan 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halmstad University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingrid Larsson, RN, PhD, Associated Professor, Halmstad University
- Investigators
- Ingrid Larsson, PhD, Principal investigator, Halmstad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180189
- Sponsor's protocol ID
- 1SLEEP
- Status last verified
- Feb 2023
- First submitted
- 21 Nov 2019
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larsson I, Aili K, Nygren JM, Johansson P, Jarbin H, Svedberg P. SLEEP: intervention with weighted blankets for children with attention deficit hyperactivity disorder (ADHD) and sleep problems: study protocol for a randomised control trial. BMJ Open. 2022 Jan 4;12(1):e047509. doi: 10.1136/bmjopen-2020-047509.
PubMed 34983749
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SLEEP - An Intervention With Weighted Blankets for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Sleep Problems
- ClinicalTrials.gov ID
- NCT04180189
- Acronym / sponsor ID
- 1SLEEP
- Conditions
- Adhd, Sleep Disturbance
- Keywords
- children, non-pharmacological intervention, ADHD, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Halmstad UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 27 Nov 2019 (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 of the study is to evaluate a sleep intervention with weighted blankets for children with ADHD and sleep problem regarding health-related outcomes, sleep, and cost-effectiveness.
The study is an RCT with cross-over design. The participants will be randomized to start with an active or placebo blanket, and then change blankets during the 16 week study period.
Detailed description
There is limited evidence about health outcomes or health-economic benefits of sleep interventions with weighted blankets for children with neuropsychiatric syndromes (NPS).
The aim of the study is to evaluate a sleep intervention with weighted blankets for children with ADHD and sleep problem regarding health-related outcomes, sleep, and cost-effectiveness.
The participants, n=100 children between 6 and 13 years old, will be recruited from the ADHD unit in Child and Adolescent Mental Health Service (CAMHS) and randomly assigned into two groups: Fiber Weighted Blankets (intervention 1) and Control Blankets (controls).
The children will use each blanket respectively for 4 weeks, then change blankets. A long term follow-up will be conducted 16 weeks from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weighted fiber blanket | Active comparator | Other: Weighted fiber blanketUsing a weighted blanket |
| Regular fiber blanket | Placebo comparator | Other: Weighted fiber blanketUsing a specially designed fiber blanket without extra weight. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children diagnosed with ADHD with sleep problems (defined by screening instrument). -
- Being a patient at child and adolescent mental health service (CAMHS) in Region Halland, Sweden.
- Parents and children should understand (written and spoken) Swedish language.
Key exclusion criteria (2 listed)
- Already used weighted blankets as a sleep intervention,
- If they have received a new prescription or change of pharmacological treatment for sleep problems
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 |
|---|---|---|
| Weighted fiber blanketUsing weighted blanket for four weeks | Other | Regular fiber blanket, Weighted fiber blanket |
Primary outcome
Sleep efficiency
Time frame: 1 week
objectively measured with actigraph during one week
Sleep onset latency
Time frame: 1 week
objectively measured with actigraph during one week
Wake after sleep onset
Time frame: 1 week
objectively measured with actigraph during one week
Total sleep time
Time frame: 1 week
objectively measured with actigraph during one week
Self-reported sleep (Parental reported)
Time frame: 1 week
Subjectively measured sleep problems in smaller children, assessed by Child's Sleep Habits Questionnaire (CSHQ), assessed by the parents, referring to last week. consists of 33 items related to eight subscales; 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. Each item is rated on a three-point scale: "usually" if the sleep behavior occurred five to seven times/week; "sometimes" for two to four times/week; and "rarely" for zero to one time/week. A higher score indicates more sleep problems
Self-reported sleep
Time frame: 1 week
Subjectively measured sleep problems in children, assessed by Insomnia Severity Index (ISI), children responding, referring to last week, comprises seven items for the children to respond to: 1) Severity of sleep-onset, 2) Sleep maintenance, 3) Early morning awakening, 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 item is rated on a five-point Likert scale ranging from "not at all" (scored at 0) to "extremely" (scored at 4). Total score ranges from 0 to 28, with higher scores indicating greater severity.
8 secondary outcomes
Parents' Health related quality of life
Time frame: 1 day
Children's Health related quality of life
Time frame: 1 day
Children's general well-being
Time frame: 1 day
Parent general well-being
Time frame: 1 day
Anxiety
Time frame: 1 day
ADHD symptoms
Time frame: 1 week
Family situation and parental mood
Time frame: 1 week
Cost effectiveness
Time frame: 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 34983749Larsson I, Aili K, Nygren JM, Johansson P, Jarbin H, Svedberg P. SLEEP: intervention with weighted blankets for children with attention deficit hyperactivity disorder (ADHD) and sleep problems: study protocol for a randomised control trial. BMJ Open. 2022 Jan 4;12(1):e047509. doi: 10.1136/bmjopen-2020-047509.
- 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. This study is not recruiting at the moment.
Ingrid Larsson, PhD principal investigator
Halmstad University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted fiber blanket in people with Adhd and Sleep Disturbance, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 Mar 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency (time frame: 1 week). The study lists 6 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 NCT04180189, 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 1 Mar 2023.