NCT07373002

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: National Defense Medical Center, Taiwan · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Family Resilience
• Parent-Infant Bonding
• Parents of Premature Infants
• Intelligent Intervention

Interventions

Type	Name	Description
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 during the infant's NICU stay and continues for one month after discharge. Participants receive reminders, feedback, and supportive information based on their responses and needs, aiming to facilitate the transition from hospital to home and improve early parenting experiences.
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-07-31
• Completion: 2029-07-31
• First posted: 2026-01-28
• Last updated: 2026-01-28