Test and evaluation of a co-created, guided, CBT-SH, e-MH intervention for parents of children treated for cancer: pilot RCT and superiority RCT with embedded mixed methods process evaluation

The purpose is to, with the co-created, gender-tailored, guided, CBT self-help, e-mental health intervention EJDeR, increase access to psychological support for parents of children treated for cancer and thereby improve parents’ mental health.The aims are to: (i) examine uncertainties associated with design and conduct of a superiority randomized controlled trial (RCT) of EJDeR plus treatment as usual (TAU) vs TAU for treatment of symptoms of depression and/or GAD in parents of children treated for cancer in a pilot RCT (CHANGE-pilot, months 0-24); (ii) examine the efficacy and cost-effectiveness of EJDeR plus TAU vs TAU for treatment of symptoms of depression and/or GAD in parents of children treated for cancer; and explore the relationships between intervention implementation, mechanisms of impact, context, and outcomes in a superiority RCT (CHANGE, months 19-60).The research is conducted with a multi-disciplinary theoretical approach by a multi-professional team from Sweden, UK, and Norway.EJDeR is optimally prepared for implementation and real-world clinical impact with significant potential to be a clinical and cost-effective solution.The research is significantly novel, e.g. (i) involvement of parent research partners in all research stages; (ii) use of an external pilot RCT plus a priori progression criteria to decide whether to proceed to the superiority RCT; and (iii) use of recruitment, retention, and adherence strategies to maximise internal and external validity.