NCT07420504

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

Efficacy of Parental Sleep Intervention on Infants and Toddlers With Behavioural Insomnia: A Longitudinal Follow-up Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Children's Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 6 Months – 36 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Behavioural Insomnia of Childhood

Interventions

Type	Name	Description
BEHAVIORAL	Sleep enhancement intervention	1. Establish a consistent and regular pre-bedtime routine. Individual activities suitable for infants include bathing, touching, story reading, and etc are selected. The whole activity process should gradually move to the children's bedroom and end in the children's bedroom, so that children can gradually establish the relationship between the bedroom, bed and sleep. 2. Place infants on the bed when they are on the verge of falling asleep. Guide parents to recognize the signs of children's sleepiness. Put them on the bed when the child sends sleepy signals but while still awake, which will improve their ability to fall asleep independently. 3. Method of graduated extinction. Caregivers are allowed to briefly comfort the child after a period of crying. The waiting time of the progressive method depends on the specific situation. Parents wait a few minutes after the child gives a crying signal before going to comfort them, and gradually extend the waiting time.

Timeline

• Start date: 2026-03-20
• Primary completion: 2027-10-13
• Completion: 2027-12-31
• First posted: 2026-02-19
• Last updated: 2026-02-19