Directed psychoeducational tool to prevent psychological sequelae following paediatric intensive care admission: a prospective randomised controlled study (the 4PICU study).

Objective: To determine if an age-appropriate intervention is more effective than treatment as usual (TAU) in reducing post-traumatic stress disorder (PTSD) symptoms in parents/guardians of children discharged from paediatric intensive care unit (PICU).

Design: A two-arm, parallel-group, single-centre randomised controlled trial.

Setting: PICU, St Mary's Hospital, London, UK.

Patients: Children admitted to the PICU between July 2021 and September 2022, with a length of stay >24 hours, and a corrected gestational age of >36 weeks at the time of PICU admission, up to <16 years of age. Parents/guardians were required to be >18 years old. We predefined subgroups of children as those <4 years and those ≥4 years.

Intervention: An age-appropriate educational booklet given at PICU discharge and a targeted telephone call at 6 weeks posthospital discharge.

Main outcomes and measures: Parental PTSD symptoms 6 months after PICU discharge, measured by the Impact of Events Scale-Revised (IES-R).

Results: 679 children were admitted to PICU, 212 were eligible for enrolment, 81 declined and 131 were included, of which 126 completed the study. 64 were randomised to TAU and 62 to intervention. 6-month questionnaires were returned by 60 families (36 from TAU group and 24 from intervention group (p=0.049)). There was no significant difference in IES-R scores between the TAU and intervention groups overall (IES-R score 37 vs 17 (p=0.132)). The ≥4-year intervention group had lower IES-R scores compared with TAU (13 in intervention vs 42 in TAU (p=0.008)). There was no difference in the <4-year group or in any secondary outcome.

Conclusions: This intervention was effective in reducing PTSD symptoms in parents of children ≥4 years after PICU discharge.

Trial registration number: NCT04635449.