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We conducted a 2-arm, cluster randomized clinical trial (NCT05662436) from February 27 to June 16, 2023, throughout Quebec, Canada, to examine the effectiveness of the Open Sky School Program (École à Ciel Ouvert) in grades 5 and 6 in French-language elementary schools, as reported by teachers and students. Schools were eligible if located within 1 km of a park or wooded area. Participation of classes within participating schools was voluntary; teachers provided written informed consent. While students could not opt out of class activities, parents provided written informed consent, and students provided assent, for assessments. The protocol was peer reviewed and published, ¹⁸ and the original protocol is provided in Supplement 1. We followed the Consolidated Standards of Reporting Trials (CONSORT) guideline ,¹⁹ including reporting of protocol deviations (eMethods 1 in Supplement 2). Two students per class were randomly selected to win a CAD$50 gift card for completion of both preintervention and postintervention questionnaires. Those who completed the 3-month follow-up had a chance to win 1 of 10 CAD $100 gift cards.

This trial uses a 2-arm cluster to further randomize the group selection as it is from the same province, school and similar regions (eg. Postal codes). The more randomness in a trial prevents bias. Peer reviewed trials are preferred in scientific studies and the reporting guidelines followed are mentioned. Gift cards were used as an encouragement to promote compliance and adherence amongst student participants who did not have options to opt out of participation if the teachers consented.

Observational studies suggest that time outdoors (ie, in nature) benefits the mental health of adults and children. A recent systematic review of 29 observational studies indicated an improvement in children’s emotional and behavioral problems, whether social (eg, victimization, low prosocial behaviors), externalizing (eg, hyperactivity), or internalizing (eg, anxiety, depression). Various initiatives have promoted outdoor play in natural environments, such as the American Academy of Pediatrics and the Canadian Paediatric Society recommendations for child development and health.^5,6 Health care professionals in many countries are recommending time in nature to alleviate mental health symptoms.⁷One of these studies reported a reduction in internalizing and externalizing symptoms among boys but not girls. The second reported an increase in prosocial behaviors in all students and a reduction in hyperactivity and peer problems among socioeconomically disadvantaged students. ¹¹However, neither study required the out-of-classroom sessions to be in green space. Furthermore, to our knowledge, the effectiveness of education in nature for reducing mental health symptoms has never been tested with a robust randomized clinical design. We designed a nature-based intervention, the Open Sky School Program, consisting of outdoor classes in a park or wooded area for 2 hours per week for 12 weeks. We hypothesized that exposure to green space would lead to reductions in mental health symptoms. we explored potential moderators of effectiveness, including student sex12,13 and disability or special needs status,¹⁴ amount of neighborhood green space ,¹⁵ a socioeconomic disadvantage indicator¹¹ of each school, and prior outdoor teaching experience of the teacher.¹⁶

One of the attractive features of this study is that most prior studies have been observational ones while this is the first of its kind to have a controlled randomized trial with regards to the effects of green space on mental health. The study requires a specific amount of open sky exposure/nature walk study that is also not seen in prior observational studies. This study serves as scientific evidence backing for already recommended nature walks by important organizations like American Academy of Pediatrics and the Canadian Paediatric Society. It is important to note that changes expected in mental health are only assessed to improve in three categories which is social health, internalizing or externalizing and not others. Another important factor to note is that previous studies showed positive results in boys over girls and this study had more girls in it. Post hoc analyses also found factors that could have affected result findings.

Mean (SD) age of student participants was 10.9 (0.75) years, 493 (48.6%) were boys, 507 (50.7%) were girls, and 112 (11.0%) were born outside Canada (Table 1). There was a greater proportion of boys in the intervention group than in the control group (265 [51.5%] vs 228 [45.6%]). Teaching experience was slightly higher in the intervention group (mean [SD], 17.01 [8.54] vs 13.82 [7.89] years), and more students in the intervention group had teachers born outside Canada (124 [24.1%] vs 82 [16.4%]). About half of all students in both groups had teachers with no prior experience teaching outdoors (intervention, 219 [42.5%]; control, 238 [47.6%]). The socioeconomic disadvantage indicator of the schools was about 1 point higher in the control group than in the intervention group (mean [SD], 5.81 [2.56] vs 4.18

[3.32]) (Table 1).

The results state how many participants were approached and used for the study. This is important to know because it is reported later in the study that of the many participants only a few were able to achieve 80% of the required time requirement for nature study. The results also assessed post hoc analyses findings. Boys were found to have more positive results in previous observational studies and were higher in number in the tested group. The mean age group was taken and children with possible socioeconomic disadvantages were considered, for example living or coming from regions without nature or parks in close residential range. Although teachers were experienced it is important to note that about 50% of them did not have experience teaching outdoors. The results  state facts of the study.

we found no overall changes in children’s mental health immediately after the intervention (ie, at 12 weeks) in the intent-to-treat or per-protocol analysis. Post hoc analyses suggested a small favorable outcome for teacher-reported internalizing symptoms, externalizing symptoms, and social problems for children with higher symptom levels at baseline. Notably, the intervention did not worsen mental health. Together, these findings indicate that the intervention may, at a minimum, be helpful in reducing disparities in mental

health in children with preexisting symptoms. Teachers in both groups expressed interest in teaching outdoors in natural surroundings. Post hoc moderation analyses revealed low levels of mental health symptoms at baseline. As such, we realized that the intervention could not decrease problems that were already low or non-existent.

The discussion of the results finds no overall change in mental health despite boys being in higher number of the tested group. No adverse effects on mental health were found from the study and it was established that the results could possibly be due to two factors, a self-reporting mental health assessment which could have been affected by the school timeline of a scheduled break in class. No prior assessment of existing mental health conditions at the baseline. On a note unrelated to the results teachers did express interest in teaching outdoors.

In future, the timeline of this study should be during a time when school breaks or examinations cannot factor into the children’s stress levels. Teachers should have a baseline training on how to conduct outdoor sessions so that everyone is at the same standardized level of conducting the outdoor lesson. More importantly, subjects taken into the study consideration should have a baseline of mental health issues to b considered for the study. These issues should be assessed by a trained professional and improvements should be assessed via DSM-5 questionnaires.  More studies should be conducted factoring out the post hoc analyses with more methodical procedures to get subjects with mental health conditions as a baseline where nature is recommended over medication for treatment. Although this reduces the sample size, it could be open to more provinces to increase random selection and sample size.

The most challenging part to understand is the statistical values which is found in the tables of the discussion section. Standard deviation is used and the higher the number means more the deviation and variability and so less consistency. It is therefore importance to understand that low standard deviations are preferred to show results closer to the mean average. The statistical significance in relation to the hypotheses is hard to understand especially with so many other factors like gender, self-reporting or socioeconomic factors that could have affected the results. Since there is no comparison study and this is first of its kind, I feel that it has value but is hard to understand the results since so many factors were not considered in the population, the most important being underlying mental health issues. How can we find an improvement in mental health if it is not a preexisting condition in the sample.