A Longitudinal Study of Parental Sleep Intervention for Behavioral Insomnia in Early Childhood

The global incidence of mental illness among children and adolescents is rising, drawing increasing attention to early risk factors and preventive strategies. Behavioral sleep problems, which affect up to 50% of infants in the local population, are closely linked to impaired self-regulation-a core factor underlying many psychological disorders and a promising target for early intervention. Enhancing self-regulation may not only alleviate sleep problems but also mitigate long-term mental health risks. This study aims to develop an intervention toolkit based on current guidelines and high-quality evidence, integrating parent education with dynamic sleep assessment and longitudinal evaluation of self-regulation in infants. The project seeks to establish the efficacy of this approach, identify moderators of intervention outcomes, and provide an evidence base for personalized sleep interventions in clinical practice.

NCT Number	NCT07420504
Lead Sponsor	Children's Hospital of Soochow University
Conditions	Behavioural Insomnia of Childhood
Enrollment	30 participants
Start Date	2026-08
Primary Completion	2028-08 (estimated)
Study Completion	2028-08 (estimated)
Updated on ClinicalTrials.gov	2026-07-10