About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Intervention A
DeviceWeighted blanket
Intervention B
DrugStandard treatment (melatonin)
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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.
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.
Interviews with clinical staff
Individual interviews and/or focus group interviews will be carried out with clinical staff concerning the implementation of the intervention.
Sponsors and contacts
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