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
Abstract
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…
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Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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