Evidence map›Paper›PMID 42642740›Full record

ArticleBMC psychiatry2026

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.

Ingrid Larsson, Petra Svedberg, Håkan Jarbin, Jens Nygren, Annelie Lindholm, Katarina Aili, Julia S Malmborg

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychiatry, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06808425 (Intervention With Weighted Blankets for Children With ADHD and Sleep Problems), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06808425 narecruitingnot on this map

Intervention With Weighted Blankets for Children With ADHD and Sleep Problems: Implementation and Effectiveness

TypeinterventionalSponsorHalmstad UniversityRan2025 to 2034Enrolled200ConditionsADHD, Sleep Disturbances, Sleep, Sleep ProblemsArmsIntervention A, Intervention B
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Ingrid LarssonSchool of Health and Welfare, Halmstad University, Box 823, Halmstad, SE-301 18, Sweden. ingrid.larsson@hh.se.ORCID https://orcid.org/0000-0002-4341-660X
Petra SvedbergSchool of Health and Welfare, Halmstad University, Box 823, Halmstad, SE-301 18, Sweden.ORCID http://orcid.org/0000-0003-4438-6673
Håkan JarbinFaculty of Medicine, Lund University, Lund, Sweden.ORCID http://orcid.org/0000-0003-3533-453X
Jens NygrenSchool of Health and Welfare, Halmstad University, Box 823, Halmstad, SE-301 18, Sweden.ORCID http://orcid.org/0000-0002-3576-2393
Annelie LindholmSchool of Health and Welfare, Halmstad University, Box 823, Halmstad, SE-301 18, Sweden.ORCID http://orcid.org/0000-0003-4451-1593
Katarina AiliSchool of Health and Welfare, Halmstad University, Box 823, Halmstad, SE-301 18, Sweden.ORCID http://orcid.org/0000-0003-4260-7399
Julia S MalmborgSchool of Health and Welfare, Halmstad University, Box 823, Halmstad, SE-301 18, Sweden.ORCID http://orcid.org/0000-0001-9918-461X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSleep problems are common in children with attention-deficit/hyperactivity disorder (ADHD), yet the real-world use, implementation, and long-term outcomes of weighted blankets and standard melatonin treatment remain understudied. This study protocol describes a research project evaluating the real-world effectiveness and implementation of a weighted blanket intervention and standard melatonin treatment for children with ADHD and sleep problems in routine clinical practice. The project focuses on (1) changes over time in sleep, health-related outcomes, and resource utilization within and across treatment arms, and (2) barriers and facilitators to implementation in routine clinical practice.

methodsThe research project uses: (1) a pragmatic longitudinal cohort design to investigate real-world changes over time in sleep, health-related outcomes, and healthcare resource utilization among children receiving either a weighted blanket intervention or standard melatonin treatment, and (2) a process evaluation design to evaluate implementation in routine clinical practice. Approximately 150 child-parent dyads will be included in each treatment arm. Children aged 6-14 years and one of their parents will each complete questionnaires at baseline, before treatment starts, at 1, 3, 6, and 12 months, and then annually for an additional nine years. The questionnaires assess sleep problems using the Children's Sleep Habits Questionnaire (CSHQ) total score as the primary sleep outcome, treatment adherence and treatment changes, additional sleep-related measures, everyday function, lifestyle habits, worry and anxiety, ADHD-related symptoms, health-related quality of life, pain, resource utilization, and treatment use and implementation. Child-parent dyads and clinical staff members will be interviewed at 6 and 12 months. Appropriate parametric and non-parametric statistical tests will be performed. Interviews will be analyzed using qualitative content analysis. The implementation process will be analyzed using a convergent parallel mixed methods approach. DISCUSSION: The project has the potential to inform clinical guidelines and decision-making frameworks for personalized care for children with ADHD. By evaluating patterns of treatment use and treatment change, real-world outcomes, and implementation in routine clinical practice, the project may contribute knowledge about the role of weighted blankets as a non-pharmacological treatment option alongside standard melatonin treatment.

trial registrationhttp://ClinicalTrials.gov , NCT06808425; registered 29 January 2025.

Indexed as

Attention Deficit Disorder with HyperactivityMelatoninSleep Wake DisordersAdolescentChildFemaleHumansLongitudinal StudiesMalePragmatic Clinical Trials as TopicSurveys and QuestionnairesTreatment OutcomeMelatoninAttention-deficit/hyperactivity disorderChildrenChildren’s sleep habits questionnaire (CSHQ)EQ-5D-Y-3LHealthImplementationMelatoninSleep interventionWeighted blanket

Identifiers

PMID42642740
PMCPMC13508435

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.