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Un estudio longitudinal de intervención del sueño parental para el insomnio conductual en la primera infancia (SuSleep)

8 de julio de 2026 actualizado por: Tingyu Rong, Children's Hospital of Soochow University

Eficacia de la Intervención del Sueño Parental en Bebés y Niños Pequeños con Insomnio Conductual: Un Estudio de Seguimiento Longitudinal

La incidencia global de enfermedades mentales en niños y adolescentes está aumentando, lo que atrae una atención creciente hacia los factores de riesgo tempranos y las estrategias preventivas. Los problemas de sueño conductuales, que afectan hasta al 50% de los lactantes en la población local, están estrechamente relacionados con la autorregulación deteriorada, un factor central subyacente a muchos trastornos psicológicos y un objetivo prometedor para la intervención temprana. Mejorar la autorregulación puede no solo aliviar los problemas de sueño, sino también mitigar los riesgos de salud mental a largo plazo. Este estudio tiene como objetivo desarrollar un conjunto de herramientas de intervención basado en las pautas actuales y evidencia de alta calidad, integrando la educación de los padres con la evaluación dinámica del sueño y la evaluación longitudinal de la autorregulación en lactantes. El proyecto busca establecer la eficacia de este enfoque, identificar moderadores de los resultados de la intervención y proporcionar una base de evidencia para intervenciones de sueño personalizadas en la práctica clínica.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Porcelana
    • Jiangsu
      • Suzhou, Jiangsu, Porcelana
        • Childrens' Hospital of Soochow University
        • Contacto:
          • Tingyu Rong, Doctor
          • Número de teléfono: 86+0512-80691135
          • Correo electrónico: tyrong@suda.edu.cn

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  1. Niños de 0 a 3 años.
  2. Diagnosticados con insomnio conductual.
  3. Consentimiento de los padres para la participación.

Criterios de exclusión:

  1. Enfermedades crónicas o antecedentes de traumatismo craneal.
  2. Otros trastornos primarios del sueño (p. ej., SAOS, narcolepsia, síndrome de piernas inquietas).
  3. Retraso del desarrollo, epilepsia u otros trastornos neurológicos/metabólicos.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Conductual: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sleep efficiency (SE) measured by Actigraphy
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sleep onset latency (SOL) measured by Actigraphy
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Maternal excessive daytime sleepiness measured by the Epworth Sleepiness Scale (ESS)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Children's Hospital of Soochow University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de agosto de 2028

Finalización del estudio (Estimado)

1 de agosto de 2028

Fechas de registro del estudio

Enviado por primera vez

4 de febrero de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de febrero de 2026

Publicado por primera vez (Actual)

19 de febrero de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2025CS038

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Los datos individuales de los participantes recopilados en este estudio no estarán disponibles para compartir. El consentimiento informado obtenido de los participantes no incluye disposiciones para el intercambio público de datos. Para proteger la privacidad y confidencialidad de los participantes, y de acuerdo con las aprobaciones éticas que rigen este estudio, los datos se mantendrán de forma segura por el equipo de investigación y no se depositarán en un repositorio público.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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