Clinical trial NCT05662436: Protocol for the Open Sky School
Official title: Protocol for the Open Sky School: A Two-arm Clustered Randomized Controlled Trial to Test the Effectiveness of a Nature-based Intervention on Mental Health of Elementary School Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Behavior
Keywords: school-based intervention
mental health
children
randomized controlled trial
nature
outdoor education
elementary-school children
greenspace
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Observatory for Children's Education and Health
First posted: 2022-12-22
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Additional inclusion criteria for schools are: (a) access to a natural environment (e.g., park, wooden area) on school grounds or within 1 km of the school and (b) having 6th grade teachers provide informed and written consent to participate in this study. Inclusion criteria for children are (a) enrollment in 6th grade, (b) providing their assent and (c) having their parents or legal guardians provide informed written consent.

Primary outcomes:
measure: Change from Baseline Child Mental Health at 3 months
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change from Baseline Child Mental Health at 6 months
timeFrame: Baseline, 6 months
measure: Change from Baseline Child Depressive symptoms at 3 months
timeFrame: Baseline, 3 months
measure: Change from Baseline Child Depressive Symptoms at 6 months
timeFrame: Baseline, 6 months
measure: Change from Baseline Child Positive and Negative Affect at 3 months
timeFrame: Baseline, 3 months
measure: Change from Baseline Child Positive and Negative Affect at 6 months
timeFrame: Baseline, 6 months
measure: Change from Baseline Child Connection with Nature at 3 Months
timeFrame: Baseline, 3 months
measure: Change from Baseline Child Connection with Nature at 6 Months
timeFrame: Baseline, 6 months
measure: Change from Baseline Child Pro-environmental Behaviors at 3 Months
timeFrame: Baseline, 3 months
measure: Change from Baseline Child Pro-environmental Behaviors at 6 Months
timeFrame: Baseline, 6 months
measure: Child's Appreciation of the Program
timeFrame: 3 months
measure: Change from Baseline Teacher Well-being at 3 Months
timeFrame: Baseline, 3 months
measure: Change from Baseline Teacher Positive and Negative Affect at 3 Months
timeFrame: Baseline, 3 Months
measure: Teacher's Enjoyment of Outdoor Education
timeFrame: 3 months
measure: Teacher's Qualifications and Experience
timeFrame: Baseline
measure: Teacher's Experience Teaching Outdoors
timeFrame: Baseline
measure: Green Space of Neighborhoods
timeFrame: Baseline
measure: Disability Status of Children
timeFrame: Baseline
measure: Child's Sex
timeFrame: Baseline
measure: School's Level of Socio-economic Deprivation
timeFrame: Baseline
Other outcomes:
measure: Adherence Assessments: Teacher Logbook
timeFrame: Weekly during the intervention phase (12 weeks) in the intervention group
Locations:
city: Montreal
country: Canada
facility: Douglas Mental Health University Institute
state: Quebec
Study officials:
affiliation: McGill
name: Marie-Claude Geoffroy, PhD
role: PRINCIPAL_INVESTIGATOR
References: