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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNational Defense Medical Center, Taiwan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Routine Care

    Other intervention

    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 groups

300 Participants
are divided into 2 treatment groups
Group A: Intelligent Intervention to enhance Parent-Infant Connection and Family ResilienceExperimental treatment 2 interventions
Group B: Routine care groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
2

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.

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

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.

Time frame
At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
4

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.

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

Secondary outcomes

1

Change in Quality of Life

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.

Time frame
At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
2

Change in Parental Self-Efficacy

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.

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

Change in Subjective Sleep Quality

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.

Time frame
At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
4

Change in Objective Sleep Indicators

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).

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

Other outcomes

Locations

This trial has no locations.

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