Development and Evaluation of an Intelligent Parent-Infant Connection-Based Intervention to Strengthen Family Resilience in Preterm Infant Care

Официальное название

Development, Optimization, and Effectiveness Evaluation of an Intelligent Parent-Infant Connection-Based Family Resilience Intervention: A Longitudinal Study of Parental Psychosocial Health From Hospitalization to Post-Discharge in Preterm Infants

Обзор

This study aims to develop, optimize, and evaluate the effectiveness of a family resilience intervention centered on intelligent parent-infant connection for parents of preterm infants. Using a longitudinal randomized controlled trial design, it examines the intervention's impact on parental psychosocial health, parenting efficacy, family resilience, and parent-infant interaction from NICU hospitalization to six months post-discharge.

Подробное описание

This longitudinal randomized controlled trial evaluates a family resilience intervention centered on intelligent parent-infant connection, designed for parents of preterm infants hospitalized in the NICU. The study recruits approximately 150 dyads of preterm infants' parents over three years at Tri-Service General Hospital, Taiwan. The intervention group receives routine care plus a digitally delivered support program during hospitalization and the first month after discharge, while the control group receives routine clinical care only. The intervention comprises low-burden, accessible modules focusing on parent-infant interaction, caregiving competence, emotional support, and paternal involvement. Data are collected at five time points: baseline (within 1 week of NICU admission), pre-discharge, and one, three, and six months post-discharge. Outcomes include family resilience, parenting efficacy, parent-infant bonding, psychological stress, sleep quality, and biological stress indicators (salivary cortisol). The study aims to establish the intervention's effectiveness in improving the psychosocial well-being of preterm infants' parents and supporting family adaptation across care transitions.

Вмешательства

• Поведенческое Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience
  This is a structured, mobile-based behavioral intervention designed to support the psychosocial health and caregiving competence of parents with preterm infants during and after NICU hospitalization. The intervention includes educational modules, interactive messages, and self-guided activities delivered through a digital platform. Content is tailored to promote parent-infant bonding, enhance parenting confidence, strengthen family resilience, and reduce parenting stress. The intervention begins
• Другое Routine Care
  Participants in this group will receive routine care as provided in the NICU and after discharge, including standard parent education and support without access to the digital intervention program. They will complete the same assessments as the experimental group across five time points from hospitalization to six months post-discharge.

Первичные конечные точки

• Change in Family Resilience [Срок оценки: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.]
• Change in Parent-Infant Bonding [Срок оценки: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.]
• Change in Perceived Stress [Срок оценки: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.]
• Change in Postpartum Specific Anxiety [Срок оценки: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.]
• Change in Salivary Cortisol [Срок оценки: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.]
• Change in Family Hardiness [Срок оценки: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.]
• Change in Maternal Postnatal Attachment [Срок оценки: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.]
• Change in Maternal Confidence [Срок оценки: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.]
• Change in Parental Role Adaptation [Срок оценки: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.]
• Change in Functional Social Support [Срок оценки: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.]

Вторичные конечные точки (5)

• Change in Quality of Life [Срок оценки: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.]
• Change in Parental Self-Efficacy [Срок оценки: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.]
• Change in Subjective Sleep Quality [Срок оценки: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.]
• Change in Objective Sleep Indicators [Срок оценки: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.]
• Change in Subjective Sleep Quality and Parameter (Sleep Diary) [Срок оценки: At baseline (before intervention),1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.]

Критерии участия

Критерии включения

• The infant is born prematurely with a gestational age of less than 37 weeks.
• At least one parent of the premature infant is aged 18 years or older and can communicate in Mandarin or Taiwanese.
• The parent(s) have provided informed consent to participate in the study.
• The parent(s) are able to comply with the data collection procedures (participation of both parents is encouraged but not required).

Критерии исключения

• The premature infant has major congenital anomalies or is assessed by clinicians as unlikely to survive.
• The parent(s) are unable to use a smartphone or internet-connected device due to technical, cognitive, or other limitations.
• The parent(s) have a known history of severe psychiatric disorders, intellectual disabilities, or substance abuse, and are assessed by the research team as being unable to comply with the study procedures or intervention requirements.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07373002 · T-NDMU-67611

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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