Not Yet RecruitingNot Applicable

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

300 participantsStarted 2026-04-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Family Resilience

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

Change in Parent-Infant Bonding

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

Change in Perceived Stress

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

Change in Postpartum Specific Anxiety

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

Change in Salivary Cortisol

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

Change in Family Hardiness

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

Trial details

NCT IDNCT07373002

SponsorNational Defense Medical Center, Taiwan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-31

Contact for this trial

Lan Hsiang-Yun, A.P.

+886287923100 Ext. 18781 shinnylan@gmail.com

View on ClinicalTrials.gov More Family Resilience trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Family Resilience

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

Change in Parent-Infant Bonding

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

Change in Perceived Stress

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

Change in Postpartum Specific Anxiety

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

Change in Salivary Cortisol

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

Change in Family Hardiness

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