RESUMEN
BACKGROUND: In Japan, 'Journey of the Brave', a cognitive behavioural therapy (CBT)-based anxiety preventive education programme, was previously developed and its effectiveness examined in two small-scale controlled trials. These studies had some limitations, including a small number of participants and not having regular classroom teachers as programme facilitators. Therefore, we conducted a large-scale controlled trial, with teachers as programme implementers. METHODS: Twenty-seven elementary schools participated: 1622 and 1123 children were allocated to the intervention and control groups, respectively. The intervention group received a programme comprising ten 45-min sessions, while the control group underwent the regular school curriculum. Anxiety symptoms among participants were assessed using the Spence Children's Anxiety Scale (SCAS) at three stages (pre-intervention, post-intervention, and follow-up). RESULTS: Following primary analysis, estimated mean changes in SCAS from baseline to follow-up were - 4.91 (95% CI - 5.91, - 3.90) in the intervention group and - 2.53 (95% CI - 3.52, - 1.54) in the control group; the group difference was 2.37 (95% CI 1.42, 3.33, p < 0.0001). Children in the intervention group showed significant reduction in their anxiety score versus children in the control group. CONCLUSIONS: The results showed a statistically significant anxiety score reduction in the intervention group, thus verifying the programme's effectiveness. Trial registration The University Hospital Medical Information Network (UMIN): UMIN000032517. Registered 10 May 2018-Retrospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037083.
RESUMEN
BACKGROUND: There is a good deal of evidence that cognitive behavioural therapy is effective for children and adolescents with anxiety-related problems. In Japan, an anxiety prevention programme based on cognitive behavioural therapy called 'Journey of the Brave' has been developed, and it has been demonstrated to be effective for elementary school students (aged 10-11 years). The purpose of this study was to have classroom teachers deliver the programme to junior high school students (aged 12-13 years) and to test the feasibility and efficacy of the programme in this setting. METHODS: This study was a prospective observational study and was approved by the Chiba University Review Board. An intervention group consisting of six classes of students in their first year of junior high school at two different schools (n = 149; 81 boys, 68 girls) received seven 50-min programme sessions. Participants in the control group were recruited from four classes of students in their second year of junior high school at one school (n = 89; 51 boys, 38 girls). All participants completed the Spence Children's Anxiety Scale at pre-test, post-test, and 2-3 month follow-up. Statistical analysis was conducted using a mixed-effects model for repeated measures model. RESULTS: Mean total anxiety scores indicated a non-significant decrease at the 2-3 month follow-up for the intervention group compared to the control group. The group differences on the SCAS from baseline to post-test was - .71 (95% CI - 2.48 to 1.06, p = .43), and the 2-3 month follow-up was - .49 (95% CI - 2.60 to 1.61, p = .64). CONCLUSIONS: In this pilot study, implementation of the programme confirmed the partial feasibility of the programme but did not elicit a significant reduction in anxiety scores. In addition, there are several methodological limitations to this study. In the future, we propose to test the feasibility and efficacy of the programme with the required sample size and by comparing groups with equal characteristics as well as by carrying out additional follow-up assessments.Trial registration UMIN000032517.