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

NCT07420504 | Not Yet Recruiting DMC

• 1 other identifier: 2025CS038
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

infant; sleep intervention; clinical cohort; toddler; self-regulation

Outcome Measures

Primary Outcomes (1)

• Sleep efficiency (SE) measured by Actigraphy

  Sleep efficiency is defined as the percentage of total sleep time (sleep period determined by the actigraphy) to the total time spent in bed (from the time children go to bed to the time they finally get up in the morning). A higher percentage reflects more continuous and higher-quality sleep. As SE is closely related to SOL and nighttime awakings, it is selected as the primary outcome of the current study.Through the built-in accelerometer and other sensors, the actigraphy can be used to monitor an individual's activity level and sleep situation, thereby analysing the child's sleep patterns such as sleep efficiency. The team technician will export the relevant sleep indicators recorded by the actigraphy and calculate relevant outcome measures. Moreover, the actigraphy is validated with parental records of sleep diaries.

  Baseline, 1 month, 6 months and 12 months

Secondary Outcomes (6)

• Sleep onset latency (SOL) measured by Actigraphy

  Baseline, 1 month, 6 months and 12 months

• Wake after sleep onset (WASO) measured by Actigraphy

  Baseline, 1 month, 6 months, and 12 months

• The number of nighttime awakenings (NW) measured by Actigraphy

  Baseline, 1 month, 6 months and 12 months

• Subjective sleep quality measured by the Brief Infant Sleep Questionnaires (BISQ)

  Baseline, 1 month, 6 months, and 12 months

• Subjective sleep quality measured by the Infant/Toddler Sleep Assessment Scale (ISAS/TSAS)

  Baseline, 1 month, 6 months, and 12 months

Other Outcomes (9)

• Maternal excessive daytime sleepiness measured by the Epworth Sleepiness Scale (ESS)

  Baseline, 1 month, 6 months, and 12 months

• Maternal mental health measured by the World Health Organisation Five Well-Being Index (WHO-5)

  Baseline, 1 month, 6 months and 12 months

• Maternal parenting stress measured by the Parenting Stress Index-Short Form (PSI-SF)

  Baseline, 6 months and 12 months

Study Arms (1)

infants and toddlers with behavioural insomnia

EXPERIMENTAL

Session 1 * Baseline feedback: Interpret parental sleep reports, actigraphy, and questionnaire data. * Daily schedule adjustment: Review current routines and guide age-appropriate daily adjustments. * Sleep environment modification: Introduce optimal sleep environment settings. * Bedtime routine development:Demonstrate how to establish an individualised bedtime routine . * Putting to bed drowsy but awake: Introduce signals of sleepiness and highlight the principle. * Graduated extinction: Detailed guidance on graduated extinction, in which parents delay responding to children's nighttime crying. * Parental rehearsal: Conduct parental rehearsal and provide tracking booklets with sleep diaries. Session 2 * Implementation review: Assess implementation feedback and troubleshoot barriers. * Sleep education: Deliver education on paediatric sleep architecture and developmental impacts. * Individualized adjustment: Provide tailored protocol modifications based on individual feedback.

Behavioral: Parental sleep enhancement intervention

Interventions

Parental sleep enhancement intervention BEHAVIORAL

The sleep intervention toolkit for this project is designed based on relevant research and guidelines. Two structured parental intervention sessions, each lasting 2 hours, will be conducted by qualified paediatricians in an intervention room within the Department of Child Health. The first session will be held within 2 weeks after the baseline evaluation, followed by the second session 2 weeks later. Up to 3 caregivers per child may attend, at least one of whom must be a parent. Each session will accommodate a maximum of three families. Adherence to the intervention will be enhanced through health education on child sleep, sharing each child's sleep status to guide tailored intervention plans, as well as providing timely sleep and developmental reports during the intervention and at each follow-up visit.

infants and toddlers with behavioural insomnia

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Participation in a new intervention program within the past 4 weeks, and/or initiation of new medication within the past 4 weeks.

Sponsors & Collaborators

• Children's Hospital of Soochow University: lead

Study Sites (1)

Childrens' Hospital of Soochow University

Suzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident/Assistant research fellow

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 19, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)