Evaluating a family-centered care intervention for reducing post-traumatic stress and aggression among parents of infants with congenital anomalies: a randomized controlled trial

Abstract

Background The NICU admission of an infant with a congenital anomaly is a major source of parental psychological distress. Family-Centered Care (FCC) is a supportive approach hypothesized to mitigate this distress. This study aimed to evaluate the effectiveness of a structured FCC intervention on reducing post-traumatic stress (PTSD) and aggression among parents of these infants. Material and method This prospective, multicenter, assessor-blind randomized controlled trial included 74 parents with clinically significant baseline PTSD symptoms. Participants were randomly assigned to either the FCC intervention group (n = 37), which received structured educational and supportive sessions, or a control group receiving standard care (n = 37). The primary outcomes of PTSD (measured by the IES-R) and aggression (STAXI-2) were assessed at baseline, immediately post-intervention, and at a one-month follow-up. Findings The FCC intervention significantly reduced PTSD (scores decreased from 44.65 +/- 5.57 pre-intervention to 24.22 +/- 8.11 at one-month follow-up, p < .001, representing a 45.8 reduction) and aggression (scores decreased slightly from 93.30 +/- 8.85 pre-intervention to 93.11 +/- 3.69 at one-month follow-up, p < .001). In contrast, the control group showed a slight increase in aggression (from 99.57 +/- 1.77 to 101.14 +/- 3.7, p < .001). These results demonstrate sustained improvements in parental mental well-being one-month post-intervention, highlighting the effectiveness of FCC in reducing psychological distress. Conclusion The findings of this study suggest that the FCC intervention was associated with reductions in PTSD symptoms and aggression among parents of infants with congenital anomalies, with effects maintained at one-month follow-up. While the observed improvements in parental mental well-being indicate the potential value of FCC in addressing psychological distress, further research is needed to confirm these results in larger, more diverse populations and over longer follow-up periods. Trial registry Iranian Registry of Clinical Trials (IRCT), Registration date 2022-09-10; URL: https://irct.behdasht.gov.ir/trial/64784 (registration code: IRCT20220605055080N1).