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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-36
SponsorChildren's Hospital of Soochow University

About this trial

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.

Eligibility criteria

Qualifiers

Children aged 0-3 years.

Diagnosed with behavioural insomnia.

Parental consent for participation.

Disqualifiers

Chronic diseases or history of head trauma.

Other primary sleep disorders (e.g., OSA, narcolepsy, restless leg syndrome).

Developmental delay, epilepsy, or other neurological/metabolic disorders.

Trial design

Treatments tested in this trial

  • Sleep enhancement intervention

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations