Stepped Care Versus Standard Care for Children After Trauma: A Randomized Non-Inferiority Clinical Trial

Objective Trauma-focused cognitive-behavioral therapy (TF-CBT) is an evidence-based therapist-led treatment for children after trauma. Parents often experience barriers to treatment engagement, including cost. Stepped care TF-CBT (SC-TF-CBT) was developed as an alternative delivery system. Step One is a parent-led therapist-assisted treatment. Step Two provides therapist-led TF-CBT for children who did not benefit from Step One and require more intensive treatment. This study compared SC-TF-CBT to standard TF-CBT in a community-based non-inferiority trial. Method A total of 183 children (aged 4-12 years) experiencing posttraumatic stress symptoms (PTSS) and their caregivers were randomly assigned to SC-TF-CBT or standard TF-CBT within 6 community clinics. Assessments occurred at baseline, mid- and posttreatment, and 6 and 12 months. Primary outcomes included PTSS and impairment. Secondary outcomes included severity, diagnostic status, remission, and response. Treatment cost, acceptability, and satisfaction were measured. Difference and non-inferiority tests were applied. Results SC-TF-CBT participants changed at rates comparable to participants in TF-CBT for primary and secondary measures. SC-TF-CBT was non-inferior to TF-CBT for PTSS, impairment, and severity at all time points except for impairment at the 6-month assessment. Attrition did not differ between treatment arms (132 participants were completers). Baseline treatment acceptability was lower for SC-TF-CBT parents, although there was no difference in expected treatment improvements or treatment satisfaction at posttreatment. Based on regression estimates, total costs were 38.4% lower for SC-TF-CBT compared to TF-CBT, whereas recurring costs were 53.7% lower. Conclusion Stepped Care TF-CBT provides an alternative way to deliver treatment for some children and parents, with reduced cost for providers and parents. Clinical trial registration information Stepped Care for Children after Trauma: Optimizing Treatment; https://clinicaltrials.gov; NCT02537678.