An Intervention With Weighted Blankets for Children With ADHD and Sleep Problems

Study Overview
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Brief Summary
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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
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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.

Official Title
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SLEEP - An Intervention With Weighted Blankets for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Sleep Problems

Conditions
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Adhd, Sleep Disturbance

Intervention / Treatment
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* Other: Weighted fiber blanket


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Already used weighted blankets as a sleep intervention, If they have received a new prescription or change of pharmacological treatment for sleep problems

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weighted fiber blanket<br>Using a weighted blanket | Other: Weighted fiber blanket<br>* Using weighted blanket for four weeks<br>|
| Placebo Comparator: Regular fiber blanket<br>Using a specially designed fiber blanket without extra weight. | Other: Weighted fiber blanket<br>* Using weighted blanket for four weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency | objectively measured with actigraph during one week | 1 week | 
| Sleep onset latency | objectively measured with actigraph during one week | 1 week | 
| Wake after sleep onset | objectively measured with actigraph during one week | 1 week | 
| Total sleep time | objectively measured with actigraph during one week | 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 | 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. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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. | 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). | 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. | 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. | 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. | 1 week | 
| Cost effectiveness | Assessed by health economic aspects, such as absence from work, productivity, contact with health-care last four weeks | 4 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, non-pharmacological intervention, ADHD, sleep