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 range18 Years – 80 Years

SexALL

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.

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.

Change in Maternal Postnatal Attachment

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 range18 Years – 80 Years

SexALL

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.

Change in Maternal Postnatal Attachment

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