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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Behavioural Insomnia of Childhood
• Intervention / Treatment: Behavioral: Parental sleep enhancement intervention

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Childrens' Hospital of Soochow University
      • Contact: Tingyu Rong, Doctor; Phone Number: 86+0512-80691135; Email: tyrong@suda.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children aged 6-36 months
2. Diagnosed with behavioural insomnia (sleep latency > 20 minutes and/or ≥ 2 nighttime awakenings per night, each lasting at least 5 minutes)
3. Daytime functional impairment (eg., excessive sleepiness, inattention, emotional problems)
4. Parental consent for participation

Exclusion Criteria:

1. Chronic diseases
2. History of head trauma
3. Other primary sleep disorders (e.g., obstructive sleep disorder, narcolepsy, restless leg syndrome)
4. Developmental delay, epilepsy, or other neurological/metabolic disorders
5. Participation in a new intervention program within the past 4 weeks, and/or initiation of new medication within the past 4 weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: infants and toddlers with behavioural insomnia; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep onset latency (SOL) measured by Actigraphy	In this study, SOL serves as the indicator of sleep initiation difficulty, with a threshold exceeding 20 minutes indicating prolonged sleep onset. Improvement in SOL (i.e., shortened latency) following the intervention will suggest enhanced self-regulation capacity and reduced reliance on parental assistance at bedtime. Moreover, the actigraphy is validated with parental records of sleep diaries.	Baseline, 1 month, 6 months and 12 months
Wake after sleep onset (WASO) measured by Actigraphy	Wake after sleep onset (WASO) is defined as the total duration of wakefulness between initial sleep onset and final morning awakening. Longer WASO indicates poorer nighttime sleep quality. Improvements (reductions) following intervention indicate better sleep consolidation. Moreover, the actigraphy is validated with parental records of sleep diaries.	Baseline, 1 month, 6 months, and 12 months
The number of nighttime awakenings (NW) measured by Actigraphy	The number of nighttime awakenings (NW) refers to the total number of awakening events lasting more than 5 minutes per night. A frequency of two or more awakenings per night may indicate poor nighttime sleep quality. This indicator will be reported to assess the degree of fragmentation of nighttime sleep. Improvements (reductions) following intervention indicate better sleep consolidation. Moreover, the actigraphy is validated with parental records of sleep diaries.	Baseline, 1 month, 6 months and 12 months
Subjective sleep quality measured by the Brief Infant Sleep Questionnaires (BISQ)	BISQ is a parent-reported instrument designed to screen for sleep problems in infants and toddlers. This study will use the standardised Chinese version, which covers multiple aspects of early childhood sleep, including sleep onset conditions, total sleep duration, nighttime awakenings, co-sleeping, and overall sleep patterns.	Baseline, 1 month, 6 months, and 12 months
Subjective sleep quality measured by the Infant/Toddler Sleep Assessment Scale (ISAS/TSAS)	ISAS and TSAS were developed and validated by the Provincial Research Working Group of Chinese Infant and Toddler Sleep Assessment Scale for children aged 4-11 months and 12-35 months, respectively. Total scores, derived from all items, reflect sleep quality, with responses rated on a four-point Likert scale of 1 to 4. Higher scores indicate poorer sleep quality.	Baseline, 1 month, 6 months, and 12 months
Self-regulation ability measured by the Age and Stage Questionnaires: Social and Emotional-2 (ASQ:SE-2)	The ASQ:SE-2 is an internationally recognised developmental screening tool for assessing social-emotional development in children aged 1 to 72 months. The questionnaire assesses a child's development across 7 specific behavioural dimensions: Self-Regulation: ability to calm or settle themselves.; Compliance: ability to follow rules and respond to limits.; Social-Communication: use of gestures, sounds, and words to interact with others.; Adaptive Functioning: ability to manage daily routines like eating, sleeping, and toileting.; Autonomy: ability to act independently and demonstrate self-confidence.; Affect: expression of feelings and emotions.; Interpersonal interaction: ability to engage with parents, other adults and children. A higher score indicates more concerning behaviours.	Baseline, 1 month, 6 months, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal excessive daytime sleepiness measured by the Epworth Sleepiness Scale (ESS)	Maternal daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS), an 8-item self-reported questionnaire employing a 4-point Likert scale of 0 to 3. It measures how likely a person is to doze off or fall asleep in 8 common, sedentary situations of daily life. Higher scores indicate greater daytime sleepiness, with a score of 10 or above indicating excessive daytime sleepiness.	Baseline, 1 month, 6 months, and 12 months
Maternal mental health measured by the World Health Organisation Five Well-Being Index (WHO-5)	Maternal mental health will be assessed using the World Health Organization Five Well-Being Index (WHO-5), a 5-item self-reported questionnaire employing a 6-point Likert scale of 0 to 5. These items reflect positive mood, vitality, and general interests over the preceding 14 days. Higher scores indicate greater well-being.	Baseline, 1 month, 6 months and 12 months
Maternal parenting stress measured by the Parenting Stress Index-Short Form (PSI-SF)	Maternal parenting stress will be assessed using the Parenting Stress Index-Short Form (PSI-SF), a 36-item parent-reported questionnaire consisting of three subscales including parental distress, parent-child dysfunctional interaction, and difficult child. The total score ranges from 36 to 180. A score of 85 or less indicates a normal level of parental stress. A score between 86 and 90 represents a critically high level. A score greater than 90 suggests a high level of parental stress, and a score of 99 or above indicates an extremely high level of parental stress.	Baseline, 6 months and 12 months
Maternal occupational stress measured by the Chinese Version of Copenhagen Psychosocial Questionnaire (COPSOQ)	Maternal occupational stress will be assessed using the short version of the Copenhagen Psychosocial Questionnaire (COPSOQ), a 44-item self-reported questionnaire consisting of eight subscales. Higher scores in the job demands and job insecurity subscales reflect greater occupational stress, whereas higher scores in the personal impact and development, interpersonal relationships and leadership, and job satisfaction subscales indicate lower levels of occupational stress.	Baseline and 12 months
Maternal life satisfaction measured by the Satisfaction With Life Scale (SWLS)	Maternal life satisfaction will be assessed using the Satisfaction With Life Scale (SWLS), a 5-item self-reported questionnaire employing a 7-point Likert scale of 1 to 7. Higher scores indicate greater perceived life satisfaction.	Baseline and 12 months
Mother-child relationship measured by the Postpartum Bonding Questionnaire (PBQ)	Mother-child bonding will be assessed using the Postpartum Bonding Questionnaire (PBQ), a 25-item self-reported questionnaire employing a 6-point Likert scale of 0 to 5. Higher scores indicate greater impairment in the mother-child relationship.	Baseline and 12 months
Family functioning measured by the Family APGAR Index (APGAR)	Maternal satisfaction with family functioning will be assessed using the Family APGAR Index (APGAR), a 5-item self-reported questionnaire employing a 3-point Likert scale of 0 to 2. Scores range from 0 to 10, with higher scores indicating better family functioning (0-3 = highly dysfunctional, 4-6 = moderately dysfunctional, 7-10 = highly functional).	Baseline and 12 months
Child temperament measured by the Carey Children Temperament Questionnaire Series	Child temperament will be assessed using age-appropriate version of scales, including the Revised Infant Temperament Questionnaire (RITQ) for infants aged 5 to 11 months, and the Toddler Temperament Scale (TTS) for children aged 1 to 3 years. Both questionnaires assess nine subscales: rhythmicity, adaptability, approach, intensity, mood, activity, threshold, distractibility, and persistence.	Baseline and 12 months
Child neurodevelopment measured by the Chinese Developmental Scale for Children Aged 0-6 years (CDSC-II)	Child neurodevelopment will be assessed using the Chinese Developmental Scale for Children Aged 0-6 Years (2nd Edition) (CDSC-II). This scale evaluates five subscales: gross motor, fine motor, adaptive ability, language, and social behaviour, comprising a total of 261 items across 28 age-in-months groups. The development quotient will be used to determine subscale-specific and overall development status, with lower scores signifying developmental vulnerability.	Baseline, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Children's Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: self-regulation; toddler; infant; sleep intervention; clinical cohort
• Additional Relevant MeSH Terms: Behavior; Social Behavior; Self-Control
• Other Study ID Numbers: 2025CS038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data collected in this study will not be made available for sharing. The informed consent obtained from the participants does not include provision for public data sharing. To protect participant privacy and confidentiality, and in accordance with the ethical approvals governing this study, the data will be kept securely by the research team and will not be deposited in a public repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No