Smart parent-child bonding program for parents of premature infants during hospitalization and after discharge
Effects of a Smart Parent-child Bonding Intervention on the Physical, Psychological, and Social Health of Parents of Preterm Infants During Hospitalization and Home Return: a Randomized Controlled Trial
This will try a smart parent-child bonding program to help parents of premature infants improve sleep, reduce stress and anxiety, and strengthen family support while the baby is in the NICU and during the first month at home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | National Defense Medical Center, Taiwan Academic / other |
| Locations | 1 site (Teipei, Taiwan) |
| Trial ID | NCT06987227 on ClinicalTrials.gov |
What this trial studies
This is a three-year randomized controlled trial using a longitudinal repeated-measures design to test an "intelligent" parent-child bonding intervention versus usual care. The study will recruit 360 parents of premature infants from a northern medical center and randomly assign participants to the intervention or control group. The intervention starts during the infant's hospital stay and continues until one month after discharge, and data are collected by questionnaires and biometric measures. Key outcomes include sleep, fatigue, stress, anxiety, depression, self-efficacy, and parent-child connection.
Who should consider this trial
Good fit: Ideal candidates are parents aged 20 or older of premature infants born before 37 weeks who are currently admitted to the pediatric or neonatal intensive care unit, can communicate in Mandarin or Taiwanese, can use mobile/internet devices, and consent to participate.
Not a fit: Parents of babies with lethal congenital abnormalities or in critical non-survivable condition, parents who cannot use mobile devices, or parents with a history of serious mental illness, intellectual disability, or substance abuse are excluded and unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve parents' sleep and mental health, strengthen parent-infant bonding, and enhance social and family functioning during a vulnerable period.
How similar studies have performed: Related interventions such as kangaroo care and digital parent-support programs have shown benefits for parental mental health and bonding, but this specific intelligent parent-child bonding program is novel and its effectiveness remains untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Parents of premature infants born less than 37 weeks of age; 2. Parents of premature infants aged 20 or above and able to communicate in Mandarin and Taiwanese; 3. Parents of premature infants agree to participate in this study and sign the research consent form; 4. The child is currently in the Pediatric and Neonatal Intensive Care Center Exclusion Criteria: 1. The premature baby has congenital abnormalities or is in critical condition and cannot survive; 2. The parents cannot use mobile phones or other Internet devices; 3. The parents have a history of mental illness, intellectual disability or substance abuse.
Where this trial is running
Teipei, Taiwan
- Hsiang-Yun Lan — Teipei, Taiwan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Lan Hsiang-Yun, A.P.
- Email: shinnylan@gmail.com
- Phone: +886287923100 Ext. 18781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.