School-Based Cognitive Behavioral Intervention Program For Addressing Anxiety In 10- To 11-Year-Olds Using Short Classroom Activities: A Quasi-Experimental Study

doi:10.21203/rs.3.rs-49225/v1

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School-Based Cognitive Behavioral Intervention Program For Addressing Anxiety In 10- To 11-Year-Olds Using Short Classroom Activities: A Quasi-Experimental Study

https://doi.org/10.21203/rs.3.rs-49225/v1

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Background: Several school-based cognitive behavioral intervention programs have been developed to prevent and improve children’s anxiety disorders. Most programs require a duration of more than 10 hours for completion. We developed a cognitive behavioral program called “Journey of the Brave.” The study aimed to examine the effectiveness of the brief version of the program among 10- to 11-year-old children using 20-minute short classroom activities.

Methods: A total of 90 children were divided into two groups (the intervention group, n=31 and the control group, n=59). The control group did not attend any program sessions and followed the regular school curriculum. We conducted fourteen weekly program sessions and assessed children at pre-intervention, post-intervention, and at 2-month follow-up (6 months after the start). The primary outcome measure was children’s anxiety symptoms, measured using the Spence Children’s Anxiety Scale (SCAS), and the secondary outcome measure was behavior problems, measured using the Strengths and Difficulties Questionnaire (SDQ).

Results: A statistically significant reduction in the SCAS score in the intervention group was found at 2-month follow up compared with the control group. Significant reduction was also observed in the SDQ score.

Conclusions: Our study suggested that this “Journey of the Brave” program, which requires only 5 hours using short classroom activities, demonstrated a similar effectiveness as the previous programs, which required over 10 hours.

Trial registration: UMIN, UMIN000009021, Registered 10 March 2012, https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000010575

Psychiatry

Prevention

Cognitive behavioral intervention

Anxiety

School based

Anxiety in childhood is often natural with development, and most of such anxiety is transitory over time and experiences [1–3]. However, some children are not able to manage anxiety, which results in dysfunction in their daily lives [4–6]. Anxiety disorder is one of the most prevalent psychological disorders in childhood and adolescence [7– 9]. Some studies have demonstrated that the 6–12 month prevalence of anxiety disorders among children and adolescents was approximately 10% [10–12].

Anxious children are prone to school maladaptation. For example, they experience panic attacks, fatigue, or sleep disturbance from anxiety, which may lead to underachievement [13]. Additionally, those with low self-esteem may avoid social relations and have negative peer interactions [14]. These problems may lead to school absenteeism [15].

Although the current record of school absenteeism in Japan, by all available measures, has not reduced yet, the Ministry of Education in Japan [16] reported that the main reason of school absenteeism in elementary schools was “emotional confusion (e. g., anxiety).” In addition, Ishikawa [17] indicated that school absenteeism is associated with anxiety and depression.

Children with behavioral problems including attention deficit hyperactivity disorder (ADHD) and conduct disorder express anxiety symptoms [1]. If left untreated, anxiety in childhood leads to significant risk of developing other psychological disorders, and impairment of development and disturbance in career domains [18–20]. Therefore, early intervention is important to prevent problems from occurring in adulthood [21–23]. The majority of anxiety disorders begin in the age range of 11 to 20 [24, 25]. Pollack [26] reported that approximately 54% of anxiety disorders in adulthood begin in childhood. Most elementary schools in Japan follow the class shuffle system in which most of the children have new classmates and are separated from old classmates when they move up from Grade 4 (9–10 years old) to Grade 5 (9–10 years old). Children may find this major change in environment to be a stressful life event, and they may feel severe anxiety. Stressful life events have been indicated as risk factors of anxiety [21, 27]. Therefore, an intervention targeting 10- to 11-year-olds in Japan who are likely to have higher anxiety is necessary.

Schools offer an optimal setting for intervention to prevent and improve anxiety among children [28–30]. Primary intervention can be defined as either universal, selected, or indicated [31]. The school setting is an ideal environment for universal intervention targeting the whole student population group [32, 33]. Schools have many advantages such as enabling easier access to program sessions, reducing stigmatization, and enhancing peer support [34–36].

Cognitive behavioral therapy (CBT) has been recommended as a treatment of choice for anxiety disorders among children [37–40]. CBT-based programs for anxiety have been developed in other countries, and their effects have been demonstrated in universal intervention at schools [41–45]. In 2014, an initiative to examine the effects of the CBT-based program “Journey of the Brave” as a pilot study for Japanese children [46] began in Japan. Although our previous research was a pilot study, “Journey of the Brave” itself was designed aimed at incorporating the universal approach (program conducted for all children) in school. This initial trial was conducted outside of the school setting as a preliminary quasi-experimental study, and the results demonstrated that the program was effective based on parents’ evaluations. This result suggested that further larger-scale research using the universal approach such as at elementary school classes is necessary to confirm its effectiveness.

Despite the fact that a CBT-based effective intervention for childhood anxiety at the school setting is available, there are barriers to its implementation in schools in Japan. One issue is the session length of the programs [47, 48]. Each session of the universal approach program usually lasts for 60–90 minutes in other countries [49], and it is estimated that the total time required to complete the program is 10–15 hours. The initial trial of “Journey of the Brave” [46] consisted of ten 45-minute sessions, taking 7.5 hours to complete. As schools have many other academic requirements and school events, pragmatic challenges such as space and time in schools need to be addressed while providing mental health programs [47, 50]. In Japan, according to elementary school curriculum guidelines set by the Ministry of Education, only approximately two hours are allocated to mental health education, which is much shorter than the time allocated to other subjects. Thus, it is difficult to make schools set a significant amount of time aside for mental health program education under the current school curriculum in Japanese elementary schools. In encouraging schools to undertake a mental health program, flexibility is an essential component to consider in managing the implementation of such programs [47]. It has been reported that teachers feel that class-based CBT is too lengthy [51], and most school staff who were engaged in CBT in the school setting suggested that it is difficult to have regular 50-minute weekly sessions, although 30-minute sessions may fit within the school schedule [48]. Therefore, we judged it advisable to use short classroom activities while implementing the mental health program to address this program length issue.

In Japan, most elementary schools have short classroom activities as part of the regular school schedule in the mornings. However, the manner in which this time is used varies depending on the school, and in most cases, the time allocated to this activity is approximately 20 minutes (e.g., 8:20 AM～8:40 AM). Activities include both active physical exercise and passive learning such as reading or calculation. It is up to each school to design the content of activities as long as it is in a manner that fits the purpose of health promotion for each child. Therefore, implementing mental health programs such as this one is appropriate.

The study aims to examine the effectiveness of implementing the CBT-based program intervention “the Journey of the Brave” using 20-minute short classroom activities in the morning among 10- to 11-year-old children.

“Journey of The Brave” Program Using Short Classroom Activities

The “Journey of the Brave” program was developed for 9- to 12-year-old children and focused on anxiety feelings and key behavior changes to deal with these feelings [46]. It consisted of 10 45-minute-long sessions each. The program contents were based on the protocol of CBT for anxiety treatment. For example, it included contents such as psychological education, relaxation, case formulation of anxiety, exposure, cognitive restructuring, and assertiveness skills when faced with social anxiety.

The “Journey of the Brave” has two major characteristics. First, among various main program contents, key concepts such as gradual exposure, hierarchy table, cognitive restructuring, and normalization, are focused upon [46]. A key element of all CBT approaches for anxiety is exposure [52, 53]. Therefore, “development of anxiety hierarchy table” and “exposure” were taught in the first half of the sessions, exposing the children gradually as the program proceeded. In addition, sessions of longer duration were dedicated to teaching cognitive restructuring so that the children could acquire not only behavioral but also cognitive skills. Simultaneously, the normalization of anxious feelings was taught carefully from the early program stage. Secondly, in order to maintain children’s interest throughout the program, an amusing story format was applied. Two likeable animal characters, one with high anxiety and the other with low anxiety, set out for a journey working on the program together with the children seeking ways to overcome anxiety. Thus, the program was titled “Journey of the Brave.” Its content and format were enjoyable and matches the children’s interests to maintain positive program motivation [46].

Based on the original program, in order to implement the “Journey of the Brave” to fit the 20-minute class activities time slot in school, we divided each session into two. In addition, we decided not to include the session on assertiveness skills, because the same theme had already been handled in the existing school curriculum. The cognitive restructuring session was allotted the entire 45 minutes to ensure children’s comprehension. As a result, the number of sessions of this program increased to 14, but the total implementation time decreased to approximately 5 hours (Table 1).

Procedure

Participants and informed consent. One school in the vicinity of Tokyo agreed to participate in this study. It was explained that by participating in this program, the children would be able to acquire specific skills to cope with current anxiety problems as well as future ones. After the explanation, consent forms were delivered to the parents by the children to provide consent on behalf of their children, and the completed consent forms were returned to the school. A total of 92 consent forms were returned (57 males, 35 females). One child did not respond because of a psychological block about coming to school (Figure 1).

Intervention group. A class consisting of 31 children was assigned to participate in the intervention study. The class was composed of 19 males and 12 females, and the average age was 10.0 years (SD = 0). Children in the intervention group received 14 weekly sessions once a week. Each child was given a workbook that he/she used throughout the program.

Control group. Two classes consisting of 31 children each were assigned to the control group. There were 36 males and 23 females, and the average age was 10.1 years (SD = 0.3). Children in the control group received the regular school curriculum (e.g., reading, calculation exercises) led by the classroom teacher.

Program facilitator and training. The “Journey of the Brave” program was led by two facilitators. The main program facilitator is the nurse teacher of the school who is majoring in cognitive behavior physiology at the time of the study. We assigned the teacher in charge of this class as the sub-program facilitator. The school principal agreed to conducting this program in the class, and parents were informed about the concept and details of the program. Prior to conducting the program, they were provided two hours’ training once every two weeks for three months by the first author who developed the original program. During the implementation phase, facilitators contacted her once a week to discuss problems and/or questions that arose during the intervention sessions and received supervision and support.

Measurements

Spence Children’s Anxiety Scale (SCAS). The primary-outcome measure was the anxiety symptoms reported by children, which was measured using the Spence Children’s Anxiety Scale (SCAS), because it is one of the most valid measurements for assessing child anxiety that met the diagnostic standard. The questions are applicable to 8- to 15-year-old children, and good reliability and validity coefficients of the SCAS Japanese version have been reported [55]. The SCAS includes 38 items regarding children’s anxiety symptoms divided into six subcategories: separation anxiety, social phobia, panic disorder/agoraphobia, generalized anxiety disorder, physical injury fears, and obsessive-compulsive disorder. SCAS scores range between 0 (never) and 3 (always), and the maximum possible score is 114.

Strengths and Difficulties Questionnaire (SDQ). The secondary outcome measure we used was behavior problems, which was measured using the self-report version of the Goodman Strengths and Difficulties Questionnaire (SDQ) [56]. The questions were applicable to 4- to 16-year-olds. Good reliability and validity coefficients of the Japanese versions of the SDQ have been reported [57]. The SDQ includes 25 items, with each item scored 0 (not true), 1 (somewhat true), or 2 (certainly true) according to the perceived severity of the symptom. The items are divided into five subcategories: emotional symptoms, behavior problems, hyperactivity/inattention, peer relationship problems, and pro-social behavior. A total difficulties score is computed by summing the scores of the first four sub categories, and the maximum possible score is 40.

Program evaluation form for children. This form was used to measure the children’s acceptance and satisfaction with the program. Participants were asked to rate the extent to which they could understand the components of this program and how helpful the skills they learned were in their daily life. This form utilized a four-point Likert-scale, and the respondents were asked to rate each item according to their own experience; the response options were “yes,” “a little,” “not really,” and “no.” A numerical equivalent was assigned to each answer, and percentages were analyzed. In addition, children were asked to write free comments about the program. Furthermore, the program sub-facilitator, who was the classroom teacher of the intervention group, asked the children to provide free comments on the quality and feasibility of the program after the intervention.

Evaluation form of the program by parents. This form was also used to assess parents’ evaluation of the program and perceived effects on their children. Parents were asked how helpful they thought the program was for their children and how this program implemented at school met their expectations. This form used a four-point Likert-scale, and each item was rated according to their own evaluation. The response options as well as analysis methods were the same as the ones for their children. Free comments were also obtained about the program.

The participating children completed a set of questionnaires at three different time points: pre-intervention, post-intervention, and at 2-month follow-up. With the exception of the evaluation form, they completed their self-report measures during regular class time. The parents of the intervention group children were hand-delivered this form at home from their children, and they returned the forms to the school after completion.

Statistical Analysis

Two children in the control group were unable to obtain signed consent forms from their parents. Therefore, a total of 90 children (31 in the intervention group, and 59 in the control group) completed the questionnaire, and their data were used for analyses (Figure 1). For the baseline variables, summary statistics were constructed using frequencies and proportions for categorical data, and means and SDs for continuous variables. The participant characteristics were compared using a chi-square test for categorical outcomes and a t-test or the Wilcoxon rank sum test for continuous variables, as appropriate.

Primary analysis was performed using the mixed-effects model for repeated measures (MMRM) with intervention group, time (week), and interactions between treatment group and time (week) as fixed effects; an unstructured covariate was used to model the covariance of within-subject variability. MMRM analysis used all the available data and assumed that any missing observations were missing at random. Under the ignorable missing data framework, MMRM analysis is a robust approach in estimating the true treatment difference and in controlling Type I error rates [58, 59]. However, in the case of data that were not missing at random, these inferential techniques that are valid for missing-at-random data are typically no longer valid [60, 61].

In order to compare the efficacy and effectiveness of the intervention program, SCAS and SDQ effect sizes (ES) estimates were calculated using Cohen’s d [62]. Cohen’s d values were calculated as the difference between the intervention group and the control group means divided by the pooled standard deviation. According to Cohen [62], an effect size of 0.2 is considered small, 0.5 is considered medium, and 0.8 is considered large.

All statistical tests were two-tailed, and a p value of .05 was employed. Other statistical analyses were performed with IBM SPSS Statistics for Windows, Version 17.0 (IBM, Armonk, New York, USA), and SAS software version 9.4 (SAS Institute, Cary, NC, USA).

The differences in gender and age were analyzed between the intervention group and control group children at pre-test. There were no significant differences (Table 2). Next, in order to compare the differences in baseline SCAS scores at pre-test between intervention and control groups, t-tests were conducted. There were no significant differences in SCAS scores (Table 2).

SCAS score changes are indicated in Figure 2 and Table 3. At the 2-month follow-up time point, estimated mean reductions in SCAS from baseline by MMRM were -7.17 (95% CI = -10.64 – -3.70) and -1.40 (95% CI = -3.91 – 1.11), respectively; the between group difference was -5.77 (95% CI = -10.07 – -1.47, p = 0.009; Table 4). The pre- 2-month follow up effect size (Cohen’s d) estimate was 0.46 between intervention and control groups.

In order to compare the differences in baseline SDQ scores at pre-test between intervention and control groups, t-tests were conducted. Although there was no significant difference in the SCAS score, there were significant differences in SDQ scores (Table 2).

SDQ score changes are indicated in Figure 3 and Table 3. At the 2-month follow-up time point, mean reductions in SDQ scores change from baseline were -1.81 (95% CI = -2.93 – -0.70) and-0.22 (95% CI = -1.02 – 0.59), respectively; the between- group difference was -1.60 (95% CI = -2.98 – -0.21, p = 0.024; Table 4). The pre- 2-month follow-up effect size (Cohen’s d) estimate was 0.15 between intervention and control groups.

High Anxiety Group and High SDQ Group

To evaluate the effectiveness of the program further, analyses of indicated level of children (children who already showing some sign of anxiety related program) were conducted. In order to examine the risk status of children at pre-intervention and at the 2-month follow up assessment, we used the SCAS score as the benchmark. The children were divided into “at risk for anxiety” or “normal” group on the basis of their scores. SCAS total scores in excess of 42.5, which is higher than 1 SD of the standardized SCAS in Japan [55] on pre-assessments, was considered as high-risk. This division resulted in four separate groups: (a) persisting high anxiety; at risk at both pre-intervention and at 2-month follow up, (b) improved anxiety; at risk at pre-intervention but normal at 2-month follow up, (c) worsened anxiety; normal at pre-intervention but at-risk at 2-month follow up, and (d) staying in normal ranges; normal at both pre-intervention and at 2-month follow up.

In the intervention group, one of three children who was at risk at pre-intervention remained in persisting high anxiety, and two of them improved at the 2-month follow up (Figure 4). In the control group, three of four children who were at risk at pre-intervention remained in persisting high anxiety, and one child improved. However, at the 2-month follow up, four children shifted to worsened anxiety (Figure 5).

Similarly, according to the SDQ-website (http://www.sdqinfo.com/), which is deemed as the authority in this field, SDQ total difficulties scores in excess of 18, are regarded as abnormal scores based on a large UK community sample. The children were divided into “at risk” or “normal” groups on the basis of their pre-intervention and 2-month follow-up scores. This produced four separate groups similar to the SCAS case: (a) persisting high SDQ ranges; at risk at both pre-intervention and at 2-month follow up, (b) improved SDQ ranges; at risk at pre-intervention but normal at 2-month follow up, (c) worsened SDQ ranges; normal at pre-intervention but at-risk at 2-month follow up, and (d) persisting normal ranges; normal at both pre-intervention and at 2-month follow up.

In the intervention group, one child who was at risk at pre-assessment, improved at 2-month follow up (Figure 6). In the control group, two out of seven children at risk pre-persisted, and five of them improved at the 2-month follow up. However, at the 2-month follow up, three children moved to the worsened ranges (Figure 7).

Evaluation Form of the “Journey of The Brave” Program

Evaluation forms by children were returned by all the children (n=31) in the intervention group. In total, 81% of the children responded that they were able to cope with anxiety by themselves, and 84% of them responded that the skills they learned during the program would be helpful in daily life. In addition, 94% of the children were satisfied with learning the program in the school setting.

On the other hand, evaluation forms by parents were returned by 29 of the parents in the intervention group. In total, 86% of them responded that the skills that the children learned during the program would be helpful in their daily life, and 97% of them felt that the program should be implemented in school settings. Excerpts of free comments about the program in the intervention group are provided in Figures 8 and 9.

Furthermore, the sub-program facilitator evaluated the program as follows:

・The timing was good because it was after the class shuffle.

・Conducting the exposure task, little by little especially, was adequate for children.

・The session pertaining to maladaptive cognition was helpful in classifying the cognitive style of my child.

・I would like to receive feedback and enhance the skills learned during the program in school life.

The results of our study demonstrated that the “Journey of the Brave” program was effective in the intervention group with a statistically significant pre- 2-month follow-up reduction in anxiety symptoms and behavior problems compared with the usual care control group despite being delivered in a short and divided time format.

SCAS

Another reason is providing the program for 10- to 11-year-old children. As mentioned before, most elementary schools in Japan have a class shuffle when children advance from the 4th grade (9–10 years old) to the 5th (10–11 years old). This environmental change poses a negative mental health effect on children and causes increased anxiety [68, 69]. It is necessary to build new friendships, and most children might be anxious during this period. In addition, Grade 5 (10- to 11-year-olds) children have a new responsibility as school leaders and increased opportunities of social communication, forcing them to face higher pressure and anxiety after the class re-shuffle. Thus, the program to manage anxiety, which consists of necessary contents for 10- to 11-year-old children to learn, matched their will to learn, and their understanding of contents deepened. In addition, it might be useful for children to learn cognitive restructuring because children understand the importance of social evaluation and their self-concept starts developing from approximately the age of eight [70]. Turner and Cole [71] reported that a negative cognitive style tended to increase with age. Brooding and worry were significantly associated with anxiety [72], and change in anxious self-talk in response to treatment may reflect the children’s success in their negative–anxious thinking pattern [73]. In one CBT-based study on depression among 9- to 10-year-old children in a universal school setting [74], the program failed to reduce anxiety. It was discussed that it is difficult for 9-year-old children to understand the cognitive component. Consequently, we consider that targeting 10- to 11-year-old children was an appropriate strategy from the aspect of the development of the cognition in children.

In order for the program to be successful, it is key to secure the motivation of children in working towards the program goal [45, 75]. With these considerations, our judgement is that the use of appropriate time, location, and age, to ensure that the students’ motivation was maintained, was the key factor resulting in a greater reduction in anxiety symptoms.

SDQ

Our results on behavior problems at the 2-month follow up indicated significant score reduction compared with the control group. It is reported that the effectiveness of CBT extends from anxiety disorders to behavior problems [76,77]. There is a study using SDQ as outcome measures, examining the effectiveness of the UK Resilience Program (UKRP) among 10- to 11-year-old children in a school setting in the United Kingdom [78]. This program focused on depression and resilience, with 18 sessions. Each session lasted for 50 to 100 minutes and was delivered by school staff. Their results contradicted our study with no significant difference in behavior problems between the intervention and control group. Although our study program focused only on anxiety and a brief intervention, the time required was one-third of the aforementioned study, and the fact that it yielded a significant improvement in behavior problems is indicative of its high efficiency. However, it has been noted that the effects on behavior problems are difficult to maintain [79, 80]. Furthermore, some evidence suggested that anxious children may have adolescent conduct disorder and ADHD [19, 81]. As our findings evaluate effects only until 2-month follow up, further studies are needed to examine the lingering effects on behavior problems through longer-term follow-up.

High SCAS Group and High SDQ Group

As the sample was small, we could not analyze and demonstrate the impact of the program on the high-risk group. However, two of three children who were at risk at the pre-intervention improved at the 2-month follow up. This result was similar to the previous studies conducting the “FRIENDS” program in universal school settings [42, 82], in which the percentage of improvement at risk on high anxiety children in the intervention group was 60~75%. Additionally, one child who was in the high-risk group on SDQ score as of pre-program improved at FU timing. High anxiety symptoms and behavioral problems are risk factors leading to depression, substance abuse, and suicide [83–86]. Therefore, our findings suggest that it is meaningful to offer this type of program to improve the high-risk group with a brief intervention and prevent anxiety disorder and related complications.

It should be noted that none of the children in the intervention group experienced an increase in anxiety. In contrast, three children in the control group exhibited increased anxiety.

However, it is difficult to prove the effects of the study on prevention. Further research needs to conduct long-term follow-up using measures such as the Anxiety Disorders Interview Schedule (ADIS-IV): Child and Parent Interview Schedules to determine whether they need clinical services.

According to the program evaluation form, it appears that the program satisfied almost all the children and parents in the intervention group. Furthermore, there is a possibility that the program may be useful to improve school absenteeism. Some children in the intervention group appear to have become aware of others’ anxiety indicating that they were able to identify children suffering from feelings of anxiety. This positive outcome was the result of the careful implementation of psychoeducation on anxiety management. School absenteeism may occur due to the interpersonal problem of anxiety and prejudiced comments from surrounding people. Providing the program including normalizing the anxiety may reduce and prevent school absenteeism.

In recent years, web-based intervention is gaining popularity in the treatment of anxiety disorder, and its effectiveness is being reported [87]. However, it is difficult to understand others’ feelings without face-to-face contact. Therefore, it is significantly preferable to deliver this kind of program at school settings face-to-face, in the hope that it may contribute to a reduction in school absenteeism.

Future Directions

Our finding may solve the question of who should deliver the program in school settings [75, 88]. It was reported in one study that a comparison of universal interventions implemented by teachers and those led by research staff revealed no significant differences in mean effect size [89]. In the previous study that implemented the “Journey of the Brave” program [46], the program was implemented by one of the authors. The successful intervention of our study was delivered by a nurse teacher and the classroom teacher. Although our study did not clearly demonstrate differences in effects by the person who facilitated the program, our result may be meaningful because the “Journey of the Brave” program was developed to be conducted in school classes. In particular, teachers play an important role in the implementation of the program and achievement of successful interventions. Since teacher-student relationships are generally good, teachers become easily aware of children with anxiety and help enhance their self-esteem [23, 89]. Teachers are busy and have little time to serve as the program facilitators, but recently, they have begun to be involved in mental health programs as members of the intervention team [91]. There is some evidence that demonstrates the positive effect of the FRIENDS program delivered by school nurses [82, 92]. School nurses have basic knowledge and experience of mental health problems. They are similar to nurse teachers in Japan. Thus, we consider that a nurse teacher may be able to play a key role in mental health program execution in Japan and/or help teachers implement the program. The next step is providing the opportunity of the program facilitation to not only teachers but also nurse teachers and/or school counselors. It is important to build on evidence indicating that a positive outcome will be yielded regardless of who facilitates the program.

Limitations

There are several limitations to this study that should be considered.

First, this study applied a nonrandomized control design. Silverman et al [38] suggested that conducting a study with a randomized control design is recommended in establishing evidence of CBT practices. Therefore, we need to conduct a study with a randomized block control design removing moderators and mediators of anxiety (e.g., characteristic of class, school events).

Second, our results were based on child self-report only. It is advisable to employ more objective measures, such as parent or teacher evaluation. In order to evaluate the improvements in the functional field as part of effectiveness indication, it is proposed that interview assessments and the behavior observation method should also be incorporated in future studies.

Finally, the present study does not report beyond the 2-month follow-up timing. Further research is needed to investigate longer-term follow-up (e, g., 1-year, 2-years) in determining the impact of the program over time. It has been indicated that the transition time when children advance from elementary school to junior high school is a risky period when emotional and behavioral problems occur [93]. Therefore, evaluation during this period is important in determining the long-term effects of this intervention.

The present study demonstrated that the delivery of the “Journey of the Brave” program in short classroom activities time results in a significant reduction in anxiety symptoms and behavioral problems. Our findings suggest that the program, which takes only 5 hours, has similar effectiveness as previous studies, whose programs took over 10 hours. Although the study has significant scope for improvement, it generates new possibilities of delivering the program in school settings.

CBT: Cognitive Behavioral Therapy; SCAS: Spence Children’s Anxiety Scale; SDQ: Strengths and Difficulties Questionnaire; MMRM: Mixed-Effect Model for Repeated Measures

Ethics approval and consent to participate:

This study was approved by the ethics committee of Chiba University. Signed parental consent for children participation was obtained.

Consent for publication:

Not applicable

Availability of data and materials:

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests:

The authors declare that they have no competing interests.

Funding:

This work was supported by JSPS KAKENHI Grant Number 15K21267.

Authors' contributions:

YU, MY and ES designed the study. ES managed and supervised the study. MY conducted this program and collected the data. YU and MY managed the database and YS analysed the data. YU and MY drafted the report. All authors read and approved the final manuscript.

Acknowledgements:

We would like to thank the school, children, and parents who participated in the study.

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Table 1 Outline of anxiety prevention programme of this study

Session	Content	Study objective *Exercise focus
1–4	Understanding feelings of anxiety	To understand that anxiety is an important feeling that protects one from danger and that it is not necessary to totally eliminate anxiety. ^*Clarify anxiety object and set a target
5	Body reactions and relaxation	To learn that anxiety and tension of both body and mind can be reduced by relaxation. ^*Practice and acquire techniques of breathing and muscle relaxation
6-7	Anxiety level stages and stair step exposure	To learn that it is important to gradually expose self to anxiety rather than to avoid it. ^Develop anxiety hierarchy table ^Climb anxiety ladder step by step (up to Session 14)
8-9	Anxiety cognition model	To learn that cognition, behavior, and feelings are closely connected to each other and that the level of anxiety changes with cognition. ^*Develop a triangle of cognition, behavior, and feelings
10-11	Rumination of the maladaptive cognition	To learn that anxiety will inflate by the rumination of the maladaptive cognition and lead to a vicious circle. ^*Realize maladaptive cognition
12 (45 minutes)	Cognitive restructuring when anxious	To learn that anxiety can be reduced by reviewing and restructuring cognitions when anxious. ^*Restructure cognition at anxious moments
13	Review	To review each session content with all participants. ^*Reviewing sessions one to eight
14	Summary	To confirm how anxiety level and self- confidence have changed by participating in “Journey of the Brave.” ^*Graduation ceremony

Table 2 Participants’ demographic data

	Intervention (n = 31)	Control (n = 59)	Test	P-value
Gender Female	n = 12 (39%)	n = 23 (39%)	x² = .001	0.98
Age	10.0 (0.00)	10.1 (0.30)	x² = 3.38	0.07
SCAS	17.77 (14.96)	23.83 (13.96)	t [88] = 1.91	0.60
SDQ	8.71 (4.13)	10.95 (4.99)	t [88] = 2.14	0.04*

Abbreviations: SCAS, Spence Children’s Anxiety Scale; SDQ, Strengths and Difficulties Questionnaire; SD, Standard deviation

Note. * p < 0.05

Table 3 Changes in SCAS and SDQ

		Intervention (n=31)			Control (n=59)
		Pre	Post	FU	Pre	Post	FU
SCAS	Mean (SD)	17.77 (14.96)	13.97 (12.24)	11.19　(11.63)	23.83　(13.96)	25.05　(15.25)	22.07　(14.54)
SDQ	Mean (SD)	8.71 (4.13)	8.32　(4.33)	7.29　(3.76)	10.95　(4.99)	11.08　(5.32)	10.19　(4.66)

Abbreviations: SCAS, Spence Children’s Anxiety Scale; SDQ, Strengths and Difficulties Questionnaire; FU, Follow up; SD, Standard deviation

Table 4 Estimated changes at 2 months follow up from baseline on SCAS and SDQ by mixed effects models for repeated measures (MMRM)

	Group	Estimated mean	Group difference	Between group difference (95% CI)	P-value
SCAS	Intervention	-7.17	-5.77	-10.07 ― -1.47	0.009**
	Control	-1.40
SDQ	Intervention	-1.81	-1.60	-2.98 ― -0.21	0.024*
	Control	-0.22

Abbreviations: SCAS, Spence Children’s Anxiety Scale; SDQ, Strengths and Difficulties Questionnaire

Note. * p < 0.05, ** p < 0.01

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School-Based Cognitive Behavioral Intervention Program For Addressing Anxiety In 10- To 11-Year-Olds Using Short Classroom Activities: A Quasi-Experimental Study

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