Preventive intervention for trauma reactions in young injured children: results of a multi-site randomised controlled trial

Background Young children are at particular risk for injury. Ten per cent to twenty-five per cent develop posttraumatic stress disorder (PTSD). However, no empirically supported preventive interventions exist. Therefore, this study evaluated the efficacy of a standardised targeted preventive intervention for PTSD in young injured children. Methods Injured children (1-6 years) were enrolled in a multi-site parallel-group superiority prospective randomised controlled trial (RCT) in Australia and Switzerland. Screening for PTSD risk occurred 6-8 days postaccident. Parents of children who screened 'high-risk' were randomised to a 2-session CBT-based intervention or treatment-as-usual (TAU). Primary outcomes were PTSD symptom (PTSS) severity, and secondary outcomes were PTSD diagnosis, functional impairment and behavioural difficulties at 3 and 6 months postinjury using blinded assessments. Trials were registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000325606) and ClinicalTrials.gov (NCT02088814). Trial status is complete. Results One hundred and thirty-three children screened 'high-risk' were assigned to intervention (n = 62) or TAU (n = 71). Multilevel intention-to-treat analyses revealed a significant intervention effect on PTSS severity over time (b = 60.06, 95% CI: 21.30-98.56). At 3 months, intervention children (M = 11.02, SD = 10.42, range 0-47) showed an accelerated reduction in PTSS severity scores compared to control children (M = 17.30, SD = 13.94, range 0-52; mean difference -6.97, 95% CI: -14.02 to 0.08, p adj. = .055, d = 0.51). On secondary outcomes, multilevel analyses revealed significant treatment effects for PTSD diagnosis, functional impairment and behavioural difficulties. Conclusions This multi-site RCT provides promising preliminary evidence for the efficacy of a targeted preventive intervention for accelerating recovery from PTSS in young injured children. This has important clinical implications for the psychological support provided to young children and parents during the acute period following a single-event trauma