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

NCT07373002 | Not Yet Recruiting

• 1 other identifier: T-NDMU-67611
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Psychosocial Health; Digital Health Intervention; Salivary Cortisol; Neonatal Intensive Care Unit (NICU); Physical Health; Social Health; Mental Health; Family Resilience; Parent-Infant Bonding

Outcome Measures

Primary Outcomes (10)

• Change in Family Resilience

  Family resilience will be measured using the Chinese version of the Walsh Family Resilience Questionnaire. This scale assesses key processes across three domains: family belief systems, organizational patterns, and communication/problem-solving. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is calculated by summing item scores, with higher scores indicating greater family resilience.

  At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.

• Change in Parent-Infant Bonding

  Parent-infant bonding will be assessed using the Chinese version of the Postpartum Bonding Questionnaire (PBQ), which measures the parent's emotional connection to their infant, including feelings of affection, confidence, and potential rejection or anxiety. The scale includes 25 items rated on a 6-point scale from 0 (always) to 5 (never), with some items reverse scored. Total scores range from 0 to 125; lower scores indicate stronger parent-infant bonding, while higher scores suggest bonding difficulties.

  At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.

• Change in Perceived Stress

  Perceived stress will be measured using the Chinese version of the 14-item Perceived Stress Scale (PSS-14). This scale assesses participants' subjective evaluation of stress in their lives during the past month. Each item is rated on a 5-point Likert scale from 0 (never) to 4 (very often). The total score ranges from 0 to 56, with higher scores indicating higher levels of perceived stress.

  At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.

• Change in Postpartum Specific Anxiety

  Postpartum anxiety will be measured using the Chinese version of the Postpartum Specific Anxiety Scale - Research Short Form (PSAS-RSF-C). The scale includes 16 items evaluating anxiety related to infant care, maternal competence, psychosocial adjustment, and infant safety. Items are rated on a 4-point Likert scale from 1 (not at all) to 4 (very much). Total scores range from 16 to 64, with higher scores indicating greater postpartum-specific anxiety.

  At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.

• Change in Salivary Cortisol

  Cortisol levels (in ng/mL) serve as a physiological biomarker for stress; higher levels indicate greater stress reactivity. Salivary cortisol levels will be collected using a non-invasive saliva collection method and analyzed using the SOMA real-time cortisol analysis system. Saliva samples will be collected at consistent times to control for diurnal variation.

  At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.

• Change in Family Hardiness

  The Family Hardiness Index (FHI) assesses family resilience in response to stress and crisis. It consists of 20 items measuring three dimensions: commitment, control, and challenge. Each item is rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with items 1, 2, 3, 8, 10, 14, 16, 19, and 20 reverse scored. Total scores range from 20 to 80, with higher scores indicating greater family hardiness and stronger coping abilities.

  At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.

• Change in Maternal Postnatal Attachment

  The Maternal Postnatal Attachment Scale (MPAS) evaluates the emotional quality of maternal attachment to the infant. It includes 19 items across three dimensions: quality of attachment, absence of hostility, and pleasure in interaction. Each item is re-coded to a uniform 5-point scale from 1 to 5, with some items reverse scored. Total scores range from 19 to 95, with higher scores reflecting stronger and more positive maternal attachment.

  At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.

• Change in Maternal Confidence

  The Maternal Confidence Questionnaire assesses a mother's perceived confidence in parenting, particularly in the context of premature infants. The scale consists of 14 items rated on a 5-point Likert scale from 1 (never) to 5 (always), with items 12 and 14 reverse scored. Higher total scores indicate greater maternal confidence.

  At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.

• Change in Parental Role Adaptation

  The Parental Role Adaptation Scale in Neonatal Intensive Care Units assesses mothers' adaptation to the maternal role during their infant's NICU stay. It consists of 32 items rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), covering six domains: involvement in care (14 items), self-efficacy (6), remote motherhood (3), uncertainty (4), interaction (3), and growth and development (2). Higher scores indicate better adaptation to the maternal role.

  At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.

• Change in Functional Social Support

  The Functional Social Support Scale measures caregivers' perceived social support across three dimensions: support needed, assistance received, and satisfaction. Each of the 16 items includes aspects of emotional, informational, and instrumental support. Responses are given on a 5-point Likert scale ranging from 0 (never) to 4 (always), or from 0 (not needed at all) to 4 (very much needed). Higher scores indicate stronger perceived support and fulfillment.

  At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.

Secondary Outcomes (5)

• Change in Quality of Life

  At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.

• Change in Parental Self-Efficacy

  At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.

• Change in Subjective Sleep Quality

  At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.

• Change in Objective Sleep Indicators

  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)

  At baseline (before intervention),1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.

Study Arms (2)

Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience

EXPERIMENTAL

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.

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

Routine care group

ACTIVE COMPARATOR

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.

Other: Routine Care

Interventions

Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience BEHAVIORAL

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.

Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience

Routine Care OTHER

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.

Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience; Routine care group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Lan Hsiang-Yun, A.P.

CONTACT

+886287923100 Ext. 18781; shinnylan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 28, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share