PICU diaries and parental PTSD symptoms-a pilot randomized controlled trial assessing feasibility and psychological outcomes.

Introduction: Parents of children admitted to pediatric intensive care units (PICUs) are at increased risk of post-traumatic stress disorder (PTSD), potentially affecting long-term family well-being. This analysis evaluates the feasibility of a pilot randomized controlled trial (RCT) of PICU diaries, including recruitment, retention, and data collection, while providing insights into intervention implementation. Additionally, selected exploratory findings are reported, including parental trauma-related symptoms at six months post-discharge and the potential influence of gender and resilience on suspected PTSD. Methods: This pilot RCT was conducted in the PICU of a university hospital. Families were randomized to an ICU diary intervention group (IG) or control group (CG), with stratification by child age. Feasibility outcomes included integration into routine intensive care, family recruitment and retention, and completeness of follow-up. Parents completed questionnaires at admission (T0), PICU discharge (T1), and six months post-discharge (T2). PTSD symptoms were assessed using the German Impact of Event Scale-Revised, while resilience was measured through the Resilience Scale-13. Results: Of 149 eligible families, 104 (69.8%) consented to participate, resulting in a final sample of 150 parents. Dropout until PICU discharge (T1) was 4.7%, while retention from T1 to the 6-month follow-up (T2) was 95.5%. In exploratory analyses, 19 (12.7%) parents screened positive for suspected PTSD after 6 months, providing preliminary estimates for future sample size calculations. Prevalence of suspected PTSD was 14.5% (10/69) in IG and 11.1% (9/81) in CG (OR = 1.36; 95% CI: 0.52-3.56). PTSD rates appeared higher in mothers than fathers (18.5% vs. 5.8%; OR = 3.69; 95% CI: 1.13-13.21). Parents who screened positive were more likely to exhibit lower resilience. Conclusion: This pilot study demonstrates that a RCT of ICU diaries in a PICU setting is feasible, with successful recruitment, high retention, and efficient data collection procedures. The intervention was integrated into routine care without indication of harm. Preliminary findings provide important estimates to inform the design and sample size of a fully powered trial. Future studies should further examine potential subgroup effects, including gender and resilience, as well as the impact of diary interventions at multiple time points following discharge.