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

BACKGROUND: Sleep 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. METHODS: The 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 REGISTRATION: http://ClinicalTrials.gov , NCT06808425; registered 29 January 2025.