Stepping together for children after trauma: protocol for a randomized controlled trial of a parent-led treatment in first-line services (NorStep Study).

Background: Childhood trauma is a public health challenge, and there is currently a service/needs gap. Low-intensive treatments where the task of leading the treatment is partially shifted to a caregiver can help bridge this gap by freeing therapist resources. Stepping Together for Children after Trauma (ST-CT), is a novel parent-led, therapist-assisted treatment with promising results in the U.S. Also, it has shown to be feasible as a first-line intervention in Norwegian municipal services and ST-CT is well accepted by children, caregivers, and therapists.Objective: This study is the first randomized controlled trial of ST-CT by independent researchers. The study consists of three work-packages: WP1: Investigates (a) the effectiveness of ST-CT compared to therapy as usual (TAU) in reducing post-traumatic stress symptoms (PTSS), related mental health symptoms, sleep problems and increasing daily functioning; (b) the cost-effectiveness of ST-CT compared to TAU in terms of quality adjusted life years; (c) future health care utilization. WP2: Looks at change processes in ST-CT, with changes in sleep, post-traumatic cognitions and child-parent relationship as potential mediators of reductions in child PTSS. WP3: Investigates keys to implementation into regular first-line mental health services.Methods: The study has a type 1 hybrid effectiveness-implementation design. Children between 7-12 years of age with symptoms of PTSS and their caregivers are randomized to either ST-CT or TAU and participants are assessed at five time points during the first year. Sleep quality is measured with a non-contact radar 1 week pre- and post-treatment and registry data of use of prescribed medications and mental health service utilization will be collected 3 years post-inclusion. The study aims to include 160 child-parent dyads from 30 municipalities.Conclusion: Results can help gain a better understanding of the effectiveness and change processes of ST-CT and may provide important knowledge for a future dissemination and implementation.Trial registration: ClinicalTrials.gov identifier: NCT05734547.