Abstract
BACKGROUND: Pediatric anxiety disorders are prevalent, particularly among children with anxious parents. This trial evaluated a program for anxious parents aimed at preventing offspring anxiety disorders and symptoms over 12 months. METHODS: This parallel, randomized, controlled, open-label trial was conducted at Karolinska Institutet, Stockholm, Sweden. Inclusion criteria comprised heightened parental anxiety and the child (5-9 years old) not currently meeting criteria for an anxiety disorder. The program, Confident Parents-Brave Children (CPBC) involves six video conferencing group sessions. An external researcher randomly allocated (1:1) participants to CPBC or a self-help control. The primary outcome was change in clinical severity ratings (CSR) between pre- and 12-month assessments, assessed by the Anxiety Disorders Interview Schedule. Secondary outcomes included parent-rated child anxiety symptoms and parental self-efficacy. The study was preregistered at ClinicalTrials.gov (NCT04722731). RESULTS: The trial included 215 parents (91% female) and 277 children (48% girls, mean age 7.0). At the 12-month assessment, no statistically significant difference was found between conditions on the primary outcome (change in CSR), OR = 0.67 (95% CI: 0.30, 1.48). No statistically significantly lower prevalence of anxiety disorder at the 12-month assessment was found in the CPBC group compared with the control group, OR = 0.57 (95% CI: 0.24, 1.31). When stratifying by age, children 5-6 years in CPBC showed lower risk of increased CSR, OR = 0.24 (95% CI: 0.08, 0.77), and anxiety diagnosis, OR = 0.23 (95% CI: 0.05, 0.84), compared to controls. Regarding secondary outcomes, CPBC children exhibited larger decreases in anxiety symptoms than control children from pre- to the 12-month assessment, Cohen's d = .35 (95% CI: 0.15, 0.55). Parents in both conditions showed increased parental self-efficacy over time, with no significant between-group effect. The 12-month assessment was completed by 204 parents (95%). CONCLUSIONS: The CPBC may have potential for preventing anxiety in young children; however, further research is warranted.