Protocol for the Open Sky School

Status Not yet recruiting

Clinical Trial Summary

The goal of this a randomized controlled trial to test the effectiveness of a nature-based intervention called Open Sky School to reduce mental health problems among elementary school children. More specifically a two-arm clustered randomized controlled trial will be conducted in elementary schools across Québec, Canada. Following informed consent by teachers, parents and students, schools will be randomly assigned 1:1 to the intervention or the control group with a total of 2500 6th grade students and 100 teachers expected to participate. The primary and secondary research questions are as follows. The primary research question : - Is the intervention effective in reducing mental health problems in children from pre-to-post test (Social Behavior Questionnaire: self and teacher reports) ? The secondary research questions: - Is the intervention effective in improving children's depression, positive and negative affect, nature connectedness. eco-anxiety and pro-environmental behaviors ? - Is the intervention effective in improving teachers' well-being and affect ? - Are the benefits to children sustained benefits at 3 months follow-up ? - Is the primary question moderated by child's sex, child's disability status, the green space of neighbourhoods, the school's socio-economic position and teacher's experience wtih outdoor education ? The intervention will take place outdoors in a green-space (2 hours per week for 12 weeks) and include a toolkit of 30 activities to foster well-being (e.g. mindfulness) and academic competencies (e.g. mathematics). The control group will engage in teaching-as-usual and will be provided with the activity toolkit after the trial has been conducted. Questionnaires will be administered to students before, immediately after and 3 months after the intervention in both the control and intervention groups. Teachers in both groups will complete questionnaires before and immediately after the intervention.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Child Behavior

Clinical Trial Details

NCT number	NCT05662436
Study type	Interventional
Source	McGill University
Contact	Marie-Claude Geoffroy, PhD
Phone	514-691-5931
Email	marie-claude.geoffroy@mcgill.ca
Status	Not yet recruiting
Phase	N/A
Start date	December 20, 2022
Completion date	September 23, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.