Home‐based cognitive behavioural therapy for families of young children with cancer (FAMOS): A nationwide randomised controlled trial

Introduction Evidence‐based knowledge is needed to reduce psychological symptoms in families of young children with cancer after treatment ends. Objective To evaluate the effect of a psychotherapeutic intervention, FAMily‐Oriented Support (FAMOS) on parents of young children after cancer treatment. Methods All families of children aged 0‐6 years who had been treated for cancer at one of the four paediatric oncology departments in Denmark were invited to participate after ending intensive medical treatment. The families were randomly assigned 1:1 to up to seven sessions of FAMOS, a cognitive‐behavioural manualised home intervention, for 6 months or to usual psychosocial care. The primary outcome was parents’ symptoms of posttraumatic stress disorder (PTSD) at 6 and 12 months after enrolment. The secondary outcomes were parents’ symptoms of depression and anxiety. Results We enrolled 109 families (204 parents). Parents in the intervention group did not show a statistically significant decrease in symptoms of PTSD as compared with the control group at 6 months (predicted mean difference, −0.10; 95% confidence interval [CI] −0.19, 0.01), but a statistically significant decrease was seen at 12 months (predicted mean difference, −0.15; 95% CI −0.28, −0.02), and they had significantly lower symptoms of depression at both 6 and 12 months. Differences in reductions in symptoms of anxiety were not statistically significant. Conclusions The FAMOS intervention reduced parents’ symptoms of PTSD and depression. Next step is to also report on psychological effects in the children and siblings (clinicaltrials.gov: NCT02200731).