Trial · NCT06808425
Intervention With Weighted Blankets for Children With ADHD and Sleep Problems: Implementation and Effectiveness
NCT06808425, Not applicable, Recruiting, Halmstad University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intervention With Weighted Blankets for Children With ADHD and Sleep Problems: Implementation and Effectiveness. Trials, record NCT06808425. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06808425
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intervention With Weighted Blankets for Children With ADHD and Sleep Problems: Implementation and Effectiveness
- NCT number
- NCT06808425
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 200 participants, estimated
- Lead sponsor
- Halmstad University
- Conditions
- ADHD, Sleep Disturbances, Sleep, Sleep Problems
- Interventions
- Intervention A, Intervention B
- First posted
- 2025-02-05
- Last updated
- 2025-03-14
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Insomnia Severity Index (ISI) | 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. |
| Primary | Pediatric Insomnia Severity Index (PISI) | 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. |
| Primary | Children's Sleep Habits Questionnaire (CSHQ) | 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. |
| Primary | Sleep Self Report (SSR) | 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. |
| Secondary | Child Outcome Rating Scale (CORS) | Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years | 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. |
| Secondary | Outcome Rating Scale (ORS) | Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years | 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. |
| Secondary | Work and Social Adjustment Scale, Youth version (WSAS-Y) | Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years | 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. |
| Secondary | Work and Social Adjustment Scale, Parent version (WSAS-P) | Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years | 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. |
| Secondary | The Brief Child and Family Phone Interview (BCFPI) | Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years | 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). |
| Secondary | Lifestyle habits | Baseline, 1 month (m), 3 m, 6 m, 1 year, yearly for additional 9 years | 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42642740 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT06808425/registered