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: 0 countries
• Sites: N/A

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 (4)

• Nighttime sleep efficiency measured by Actigraphy

  Sleep efficiency is defined as the percentage of total sleep time (sleep period determined by the watch) to the total time spent in bed (from the time children try to fall asleep to the time they finally wake up in the morning). A higher percentage represents a more continuous and higher-quality night's sleep. 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 nighttime sleep efficiency. The team technician will export the relevant sleep indicators recorded by the actigraphy and calculate relevant outcome measure. Moreover, the actigraphy is validated with parental records of sleep diaries.

  Baseline, 1 month, 6 months and 12 months

• Daytime napping pattern measured by Actigraphy

  Record children's sleep behaviour during the day with the actigraphy. Two main indicators are evaluated: 1. Number of naps: the number of independent sleep events that occurred during the day and lasted to the actigraphy's recognition criteria. 2. Total nap duration: cumulative time (minutes) for all sleep events during the day (defined as the time between the last awakening in the morning and the time you go to bed at night). This outcome measure is mainly reflected by the average time of daytime napping per day, which will be reported at different points to assess sleep-wake distribution throughout the day.

  Baseline, 1 month, 6 months and 12 months

• Nocturnal awakening pattern measured by Actigraphy

  The actigraphy is used to objectively quantify wakefulness events during nighttime sleep. Two main indicators are evaluated: 1. Number of awakenings: the total number of awakening events that meet the actigraphy's recognition criteria each time during the main sleep period. 2. Total Awakening Duration: the cumulative time (minutes) of all awakening events that meet the criteria. This outcome measure is reflected by the average total duration of nocturnal awakenings per day, which will be reported to assess the degree of fragmentation of nighttime sleep.

  Baseline, 1 month, 6 months, and 12 months

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

  BISQ is a questionnaire tool used to assess the sleep of infants. The questionnaire aims to collect information on infant sleep behaviour through parent-reported methods to help professionals more fully understand and evaluate infants' sleep quality and patterns. This questionnaire evaluates the changes in children's sleep duration, co-sleeping situation, night-waking situation, falling-asleep situation, and overall sleep patterns.

  Baseline, 1 month, 6 months, and 12 months

Secondary Outcomes (2)

• Self-regulating ability measured by the Age and Stage Questionnaires: Social and Emotional-2 (ASQ:SE-2)

  Baseline, 1 month, 6 months, and 12 months

• Temperament measured by the series of Carey Children Temperament Questionnaire

  Baseline and 12 months

Other Outcomes (3)

• Parent stress measured by the Parent Stress Index (PSI)

  Baseline, 6 months and 12 months

• Occupational stress measured by the Chinese Version of Copenhagen Psychosocial Questionnaire (COPSOQ)

  Baseline, 6 months and 12 months

• Degree of caregiver's daytime sleepiness evaluated by the Epworth Sleepiness Scale (ESS)

  Baseline, 1 month, 6 months, and 12 months

Study Arms (1)

infants and toddler with behavioural insomnia

EXPERIMENTAL

Behavioral: Sleep enhancement intervention

Interventions

Sleep enhancement intervention BEHAVIORAL

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.

Also known as: sleep hygiene education

infants and toddler 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 0-3 years.
• Diagnosed with behavioural insomnia.
• Parental consent for participation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Soochow University: lead

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 doctor

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 19, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): October 13, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share