Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:47 PM
Study NCT ID:
NCT07420504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Longitudinal Study of Parental Sleep Intervention for Behavioral Insomnia in Early Childhood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000068356', 'term': 'Self-Control'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Parent stress measured by the Parent Stress Index (PSI)', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'This scale is used to measure the parental stress of parents of children aged from 1 month to 12 years in three aspects, namely, parental distress, parent - child interaction disorder, 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.'}, {'measure': 'Occupational stress measured by the Chinese Version of Copenhagen Psychosocial Questionnaire (COPSOQ)', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'This study adopts a short version, which mainly includes five modules: job requirements, personal influence and development, interpersonal relationship and leadership ability, job instability and job satisfaction. The total score of the corresponding module can be obtained by calculating the sum of the average scores of the items to which the 5 modules belong. Among them, the higher the scores of "job requirements" and "job instability", the more likely it is to cause occupational stress. While the higher the scores of the other three modules means that it is less likely to cause occupational stress.'}, {'measure': "Degree of caregiver's daytime sleepiness evaluated by the Epworth Sleepiness Scale (ESS)", 'timeFrame': 'Baseline, 1 month, 6 months, and 12 months', 'description': "ESS is a standardized self-report questionnaire used to assess an individual's general level of daytime sleepiness. It measures how likely a person is to doze off or fall asleep in 8 common, sedentary situations of daily life. Each of the 8 situations is rated on a scale from 0 (no chance of dozing) to 3 (high chance of dozing). The scores for all items are summed up to produce a total score ranging from 0 to 24. The higher the score, the more severe the daytime sleepiness is, with a score of 10 or above indicating excessive daytime sleepiness."}], 'primaryOutcomes': [{'measure': 'Nighttime sleep efficiency measured by Actigraphy', 'timeFrame': 'Baseline, 1 month, 6 months and 12 months', 'description': "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.\n\nThrough 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."}, {'measure': 'Daytime napping pattern measured by Actigraphy', 'timeFrame': 'Baseline, 1 month, 6 months and 12 months', 'description': "Record children's sleep behaviour during the day with the actigraphy. Two main indicators are evaluated:\n\n1. Number of naps: the number of independent sleep events that occurred during the day and lasted to the actigraphy's recognition criteria.\n2. 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).\n\nThis 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."}, {'measure': 'Nocturnal awakening pattern measured by Actigraphy', 'timeFrame': 'Baseline, 1 month, 6 months, and 12 months', 'description': "The actigraphy is used to objectively quantify wakefulness events during nighttime sleep. Two main indicators are evaluated:\n\n1. Number of awakenings: the total number of awakening events that meet the actigraphy's recognition criteria each time during the main sleep period.\n2. Total Awakening Duration: the cumulative time (minutes) of all awakening events that meet the criteria.\n\nThis 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."}, {'measure': 'Subjective sleep quality measured by the Brief Infant Sleep Questionnaires (BISQ)', 'timeFrame': 'Baseline, 1 month, 6 months, and 12 months', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Self-regulating ability measured by the Age and Stage Questionnaires: Social and Emotional-2 (ASQ:SE-2)', 'timeFrame': 'Baseline, 1 month, 6 months, and 12 months', 'description': "ASQ:SE-2 is a screening tool used to identify infants and young children who may be at risk for social or emotional difficulties. It relies on parents' or caregivers' observations of their child's behaviour.\n\nThe questionnaire assesses a child's development across 8 specific behavioural dimensions:\n\n1. Self-Regulation: ability to calm or settle themselves.\n2. Compliance: ability to follow rules and respond to limits.\n3. Social-Communication: use of gestures, sounds, and words to interact with others.\n4. Adaptive Functioning: ability to manage daily routines like eating, sleeping, and toileting.\n5. Autonomy: ability to act independently and demonstrate self-confidence.\n6. Affect: expression of feelings and emotions.\n7. Interaction with People: ability to engage with parents, other adults and children.\n8. Overall (a general section for additional comments). A higher score indicates more concerning behaviours."}, {'measure': 'Temperament measured by the series of Carey Children Temperament Questionnaire', 'timeFrame': 'Baseline and 12 months', 'description': 'This instrument employs a standardized assessment to evaluate innate behavioral patterns and reactivity in infants. Derived from the Thomas and Chess taxonomy, it measures core temperament dimensions including activity level, rhythmicity, adaptability, approach/withdrawal, threshold of responsiveness, intensity of reaction, quality of mood, distractibility, abd persistence. The resulting profile aids in researching individual differences in developmental trajectories and informing individualized caregiving and educational strategies.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infant', 'sleep intervention', 'clinical cohort', 'toddler', 'self-regulation'], 'conditions': ['Behavioural Insomnia of Childhood']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children aged 0-3 years.\n2. Diagnosed with behavioural insomnia.\n3. Parental consent for participation.\n\nExclusion Criteria:\n\n1. Chronic diseases or history of head trauma.\n2. Other primary sleep disorders (e.g., OSA, narcolepsy, restless leg syndrome).\n3. Developmental delay, epilepsy, or other neurological/metabolic disorders.'}, 'identificationModule': {'nctId': 'NCT07420504', 'acronym': 'SuSleep', 'briefTitle': 'A Longitudinal Study of Parental Sleep Intervention for Behavioral Insomnia in Early Childhood', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Soochow University"}, 'officialTitle': 'Efficacy of Parental Sleep Intervention on Infants and Toddlers With Behavioural Insomnia: A Longitudinal Follow-up Study', 'orgStudyIdInfo': {'id': '2025CS038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'infants and toddler with behavioural insomnia', 'interventionNames': ['Behavioral: Sleep enhancement intervention']}], 'interventions': [{'name': 'Sleep enhancement intervention', 'type': 'BEHAVIORAL', 'otherNames': ['sleep hygiene education'], 'description': "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.\n2. 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.\n3. 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.", 'armGroupLabels': ['infants and toddler with behavioural insomnia']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Soochow University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Tingyu Rong', 'investigatorAffiliation': "Children's Hospital of Soochow University"}}}}