The Effect of a Family-Centered Care Program on the Psychological Outcomes of Births With Congenital Malformations: A Study Protocol Publisher



Vaez F ; Kalhor F ; Naghavi A ; Tarahi MJ ; Hemati Z
Source: Journal of Education and Health Promotion Published:2026

Abstract

BACKGROUND: The birth of a baby with a congenital abnormality causes emotional and psychological suffering for the parents. This study will aim to investigate the impact of a family-centered care program on psychological outcomes, including aggression and post-traumatic stress disorder (PTSD). MATERIALS AND METHODS: This study will be a prospective, multicenter, single-blind randomized controlled trial. The participants will include 74 parents of children with malformations who will score above 24 on the PTSD assessment using the Revised Weiss and Marmar Impact of Event Questionnaire (IES-R). Sampling will be performed in a non-proportional random stratified manner. The CONSORT-SPI guideline and SPIRIT guideline will be adhered to in this study. The control group will receive the routine intervention of the department, while the intervention group will participate in a family-oriented educational-support program based on four steps: Information exchange, self-efficacy promotion, self-confidence (self-esteem), and evaluation. Anger assessment using the Spielberger trait-state anger inventory (STAXI-2) and PTSD assessment using the IES-R questionnaire will be conducted at three stages: Before the intervention, immediately afterward, and 1 month later. The results will be compared between the two groups. CONCLUSION: To support or enhance the psychological well-being of parents with infants born with congenital malformations, there will be a pressing need for tailored interventions. This family-centered intervention, designed for all parents facing similar challenges, has the potential to significantly enhance their psychological resilience. We anticipate that implementing this intervention will lead to notable improvements in psychological outcomes, particularly in mitigating the effects of anger and PTSD, as individuals adopt effective coping strategies and adjust to their new circumstances. © 2026 Journal of Education and Health Promotion.