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En longitudinell studie av foreldrestyrt søvnintervensjon for atferdsmessig søvnløshet i tidlig barndom (SuSleep)

8. juli 2026 oppdatert av: Tingyu Rong, Children's Hospital of Soochow University

Effektiviteten av foreldres søvnintervensjon på spedbarn og småbarn med atferdsmessig søvnløshet: En longitudinell oppfølgingsstudie

Den globale forekomsten av psykiske lidelser blant barn og ungdom øker, noe som trekker økende oppmerksomhet til tidlige risikofaktorer og forebyggende strategier. Atferdsmessige søvnproblemer, som rammer opptil 50 % av spedbarn i den lokale befolkningen, er nært knyttet til svekket selvregulering – en kjernefaktor som ligger til grunn for mange psykologiske lidelser og et lovende mål for tidlig intervensjon. Å forbedre selvregulering kan ikke bare lindre søvnproblemer, men også redusere langsiktige psykiske helserisikoer. Denne studien tar sikte på å utvikle et intervensjonsverktøysett basert på gjeldende retningslinjer og høykvalitetsbevis, og integrerer foreldreopplæring med dynamisk søvnsvurdering og langsgående evaluering av selvregulering hos spedbarn. Prosjektet søker å fastslå effektiviteten av denne tilnærmingen, identifisere moderatorer for intervensjonsresultater, og tilby et bevisgrunnlag for personlig tilpassede søvnintervensjoner i klinisk praksis.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Jiangsu
      • Suzhou, Jiangsu, Kina
        • Childrens' Hospital of Soochow University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  1. Barn i alderen 0–3 år.
  2. Diagnostisert med atferdsmessig insomni.
  3. Foreldresamtykke for deltakelse.

Eksklusjonskriterier:

  1. Kroniske sykdommer eller historikk med hodeskade.
  2. Andre primære søvnsykdommer (f.eks. OSA, narkolepsi, restless legs-syndrom).
  3. Utviklingshemming, epilepsi eller andre nevrologiske/metaboliske lidelser.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sleep efficiency (SE) measured by Actigraphy
Tidsramme: Baseline, 1 month, 6 months and 12 months
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sleep onset latency (SOL) measured by Actigraphy
Tidsramme: Baseline, 1 month, 6 months and 12 months
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
Tidsramme: Baseline, 1 month, 6 months, and 12 months
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
Tidsramme: Baseline, 1 month, 6 months and 12 months
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)
Tidsramme: Baseline, 1 month, 6 months, and 12 months
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)
Tidsramme: Baseline, 1 month, 6 months, and 12 months
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)
Tidsramme: Baseline, 1 month, 6 months, and 12 months

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:

  1. Self-Regulation: ability to calm or settle themselves.
  2. Compliance: ability to follow rules and respond to limits.
  3. Social-Communication: use of gestures, sounds, and words to interact with others.
  4. Adaptive Functioning: ability to manage daily routines like eating, sleeping, and toileting.
  5. Autonomy: ability to act independently and demonstrate self-confidence.
  6. Affect: expression of feelings and emotions.
  7. 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maternal excessive daytime sleepiness measured by the Epworth Sleepiness Scale (ESS)
Tidsramme: Baseline, 1 month, 6 months, and 12 months
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)
Tidsramme: Baseline, 1 month, 6 months and 12 months
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)
Tidsramme: Baseline, 6 months and 12 months
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)
Tidsramme: Baseline and 12 months
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)
Tidsramme: Baseline and 12 months
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)
Tidsramme: Baseline and 12 months
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)
Tidsramme: Baseline and 12 months
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
Tidsramme: Baseline and 12 months
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)
Tidsramme: Baseline, 6 months and 12 months
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Children's Hospital of Soochow University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. august 2028

Studiet fullført (Antatt)

1. august 2028

Datoer for studieregistrering

Først innsendt

4. februar 2026

Først innsendt som oppfylte QC-kriteriene

11. februar 2026

Først lagt ut (Faktiske)

19. februar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025CS038

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

De individuelle deltakerdataene som er samlet inn i denne studien vil ikke bli gjort tilgjengelige for deling. Det informerte samtykket som er innhentet fra deltakerne inkluderer ikke bestemmelser for offentlig datadeling. For å beskytte deltakernes personvern og konfidensialitet, og i samsvar med de etiske godkjenningene som regulerer denne studien, vil dataene oppbevares sikkert av forskningsteamet og vil ikke bli deponert i et offentlig arkiv.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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