BackgroundThis study aims to evaluate the impact of a home-based, post-discharge early intervention (EI) program on reducing parental stress levels in families with preterm infants born between 28+ 0 and 31+ 6 weeks gestational age.MethodsA randomized controlled trial was conducted, with families randomly allocated to either the EI or standard care (SC) group. A term reference group was also recruited for comparison. The Parental Stress Index-Short Form was used to assess parental stress levels, yielding a total stress score and three subdomain scores. Assessment was performed at baseline, at the 60-day mark of the study, and when the infants reached six corrected months of age. Parents in the reference group were assessed only at six months of corrected age for infants. The intervention comprised three sections: intellectual, physical, and social training, which was administered to the infants in the EI group immediately after discharge and to those in the SC group after 60 days of enrollment.ResultsSeventy-three families were enrolled in this study, with 37 allocated to the EI group, and 36 to the SC group. Prior to intervention, higher stress levels were reported by mothers in both groups than fathers, with no difference observed between the EI and SC groups. Re-assessment performed at 60 days of the study showed that mothers and fathers in the EI group had significantly lower total stress score than those in the SC group (82.00 ± 5.64 vs. 94.26 ± 7.99, p < 0.001; 80.74 ± 7.14 vs. 89.94 ± 9.17, p < 0.001, respectively), which was predominantly due to the lower scores in parental distress and parental-child dysfunction interaction subdomains in the EI group (both had p < 0.001). Mothers in the EI group exhibited a more pronounced reduction in total stress score after intervention when compared to fathers (13.15 ± 4.68 vs. 8.26 ± 4.03, p < 0.001). At six months of infant age, the total stress score and subdomain scores of parents in the EI and SC groups were similar, but significantly higher than those of the reference group.ConclusionThe home-based, post-discharge EI program demonstrated significant effectiveness in reducing parental stress levels among the parents of very preterm infants.Trial registrationThis study was registered in the Chinese Clinical Trial Registry (registration number: CTR1900028330). Registration date: December 19, 2019.