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

National Defense Medical Center, Taiwan

Status: Begins enrollment in 1 month

Conditions: Intelligent Intervention; Parents of Premature Infants; Family Resilience; Parent-Infant Bonding

Treatments: Other: Routine Care; Behavioral: Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience

Study type: Interventional

Funder types: Other

Identifiers

NCT07373002

T-NDMU-67611

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience

Experimental group

Description:

Participants in this group will receive routine care plus an intelligent parent-infant connection-based intervention. The intervention includes access to a mobile platform that delivers structured educational content focused on premature infant care, emotional regulation, parent-infant bonding, and stress management. The program begins during the infant's NICU hospitalization and continues for one month post-discharge. Participants will also receive interactive messages, tips, and guidance to support their caregiving role and psychosocial adjustment during the transition to home care.

Treatment:

Behavioral: Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience

Other: Routine Care

Routine care group

Active Comparator group

Description:

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.

Treatment:

Other: Routine Care