Digital Cognitive Behavioral Treatment of Insomnia in Youth: Protocol for an RCT Examining Feasibility, Acceptability, and Efficacy of LAMBI

INTRODUCTION: Chronic insomnia is associated with negative effects for children (impaired academic performance, mood and behavioral dysregulation) and their caregivers (poor sleep, stress, fatigue). Chronic insomnia is also common (up to 20% of children, 50-80% in the context of comorbidities), but underdiagnosed/treated in pediatric primary care (<10% treated). Cognitive behavioral treatment for insomnia (CBTi) is the recommended "first-line" treatment for insomnia and systematic reviews and meta-analyses provide evidence of its short-term efficacy and safety in children with chronic insomnia. Unfortunately, in-person CBTi is not widely available due to a lack of and limited access to behavioral providers. Digital forms of CBTi (dCBTi) have shown promise to improve sleep and secondary outcomes in children and have the potential to rapidly increase treatment accessibility and feasibility. However, while randomized controlled trials (RCTs) of dCBTi in adolescents and adults exist, these are lacking in children. This trial will be the first to investigate the impact of a moderated dCBTi on sleep and associated outcomes of school-aged children and their caregivers compared to a waitlist control. METHODS & ANALYSIS: ) or dCBTi a month later (waitlist control). Participants will be assessed at baseline, post-treatment, 1 and 3-month follow-ups. Child assessments include objective/subjective sleep measures, daytime functioning (mood, executive functioning), quality of life (QOL), and physiological arousal (heart rate variability). Caregiver assessments include: objective/subjective sleep measures, daytime functioning (anxiety, depression, fatigue), physiological arousal, and caregiver stress. ETHICS & DISSEMINATION: Ethics approval was obtained in February 2025 from the University of South Florida. All data are expected to be collected by Spring 2027. Full trial results are planned to be published in 2027. Secondary analyses of baseline data will be subsequently published. CLINICAL TRIAL REGISTRATION NUMBER: NCT07091149.