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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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
• Other 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.

Primary outcome measures

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

Secondary outcome measures (5)

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

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07373002 · T-NDMU-67611

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗