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

July 8, 2026 updated by: Hsiang-Yun Lan, National Defense Medical Center, Taiwan

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience
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
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.
Active Comparator: Routine care group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
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
Time Frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
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
Time Frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
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
Time Frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
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
Time Frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
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
Time Frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
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
Time Frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
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
Time Frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
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
Time Frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Measured using the Taiwan version of WHOQOL-BREF, which contains 26 items covering physical, psychological, social, and environmental domains. Each item is rated on a 5-point scale. Total scores are calculated and standardized to a 0-100 scale, with higher scores indicating better 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
Time Frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Parental self-efficacy will be assessed using the Parental Self-Efficacy Scale (PSE), a 20-item instrument scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Scores range from 20 to 100. Higher scores indicate stronger parental confidence in caregiving roles.
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.
Evaluated using the Pittsburgh Sleep Quality Index (PSQI), which includes 19 items assessing sleep duration, latency, quality, and disturbances. Scores range from 0 to 21, with higher scores indicating worse sleep quality. A score >5 suggests poor sleep.
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.
Sleep duration and efficiency will be measured using the ActiGraph GT3X accelerometer, worn continuously on the non-dominant wrist for 72 hours. Data will be downloaded and analyzed to calculate total sleep time (minutes) and sleep efficiency (percentage of time asleep while in bed).
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.
This self-developed sleep diary was designed to capture sleep quality, patterns, and disturbances over a continuous 3-day period. Each morning upon waking, participants recorded their recall of the previous night's sleep, including total sleep time (in hours), number and duration of nighttime awakenings, and perceived sleep efficiency. They also noted contextual factors that may have affected their sleep, such as emotional distress, physical discomfort, medication use, or consumption of stimulants or alcohol. In addition, participants rated their perceived sleep quality and level of alertness upon waking using a 5-point Likert scale, where 1 indicated the poorest quality or alertness and 5 indicated the highest. Higher scores reflect better subjective sleep outcomes.
At baseline (before intervention),1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Defense Medical Center, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • T-NDMU-67611

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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