A Longitudinal Study of Parental Sleep Intervention for Behavioral Insomnia in Early Childhood
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- Who runs it
- Children's Hospital of Soochow University
- Trial code
- NCT07420504
- Record updated
- 10 July 2026
- Original description
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.Read full original descriptionShow less
Efficacy of Parental Sleep Intervention on Infants and Toddlers With Behavioural Insomnia: A Longitudinal Follow-up Study
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.
Inclusion: Children aged 6-36 months; Diagnosed with behavioural insomnia (sleep latency > 20 minutes and/or ≥ 2 nighttime awakenings per night, each lasting at least 5 minutes); Daytime functional impairment (eg., excessive sleepiness, inattention, emotional problems); Parental consent for participation.
Exclusion: Participation in a new intervention program within the past 4 weeks, and/or initiation of new medication within the past 4 weeks; Chronic diseases; History of head trauma; Other primary sleep disorders (e.g., obstructive sleep disorder, narcolepsy, restless leg syndrome); Developmental delay, epilepsy, or other neurological/metabolic disorders.