Protocol for the Open Sky School

NCT05662436 | Unknown

• 1 other identifier: 468540
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Behavior

Keywords

school-based intervention; mental health; children; randomized controlled trial; nature; outdoor education; elementary-school children; greenspace

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Child Mental Health at 3 months

  The Social Behavior Questionnaire is a 30 items questionnaire that will be used to assess a range of mental health symptoms in children. The frequency of children's symptoms over the last 2 months is rated on a scale 3-point (never/not true = 0, sometimes/somewhat true = 1, often/very true = 2). Overall symptoms will be examined as outcomes, as well as internalizing symptoms (emotional distress and withdrawal; 11 items), externalizing symptoms (impulsive/hyperactive/inattentive and disruptive behaviors; 13 items), and social behaviors (pro-social behavior and peer relationships; 6 items). Ratings will be obtained by both child and teacher reports which will be analyzed separately.

  Baseline, 3 months

Secondary Outcomes (19)

• Change from Baseline Child Mental Health at 6 months

  Baseline, 6 months

• Change from Baseline Child Depressive symptoms at 3 months

  Baseline, 3 months

• Change from Baseline Child Depressive Symptoms at 6 months

  Baseline, 6 months

• Change from Baseline Child Positive and Negative Affect at 3 months

  Baseline, 3 months

• Change from Baseline Child Positive and Negative Affect at 6 months

  Baseline, 6 months

Other Outcomes (1)

• Adherence Assessments: Teacher Logbook

  Weekly during the intervention phase (12 weeks) in the intervention group

Study Arms (2)

Intervention group

EXPERIMENTAL

The exposure to nature consists of teachers bringing their students to the highest quality green space within 1 km of a school which could be located on or off campus. The class will spend a total of 2 hours (i.e. 2 one hour visits or one 2 hours visits) per week for 12 weeks (transportation included). The teacher be provided with a toolkit of activities (mental health and academic competencies) that they will carry out with their students. Teachers will be provided with training and support.

Other: Open Sky School program

Control

NO INTERVENTION

Six months after the inception of the trial, elementary schools (and their teachers) in the control condition will receive an unguided version of the intervention, supplemented by an online peer support group. As the children of the control group will by then be in high school with different teachers, we will provide them with a toolkit of 10 mental health activities that they can practice alone, in addition of support via video-conference, phone or email if they require help practicing the activities from a member of the research team. As in the intervention group, we will provide support by licensed psychologists to any children who report high levels of psychological distress and orient children to appropriate services if needed.

Interventions

Open Sky School program OTHER

Teachers lead students in 2 hours of outdoor activities per week for 12 weeks, as detailed in the arm description

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• McGill University: lead
• Observatory for Children's Education and Health: collaborator

Study Sites (1)

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Location

Related Publications (2)

• Loose T, Fuoco J, Malboeuf-Hurtubise C, Ayotte-Beaudet JP, Gauvin L, Chadi N, Ouellet-Morin I, Masse B, Cote SM, Geoffroy MC. A Nature-Based Intervention and Mental Health of Schoolchildren: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2444824. doi: 10.1001/jamanetworkopen.2024.44824.

  PMID: 39546315 DERIVED

• Loose T, Cote S, Malboeuf-Hurtubise C, Beaudet JA, Lessard G, Chadi N, Gauvin L, Morin IO, Geoffroy MC. 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. BMC Public Health. 2023 Feb 3;23(1):236. doi: 10.1186/s12889-023-15033-y.

  PMID: 36737725 DERIVED

MeSH Terms

Conditions

Child Behavior; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavior; Personal Satisfaction

Study Officials

• Marie-Claude Geoffroy, PhD

  McGill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Claude Geoffroy, PhD

CONTACT

514-691-5931; marie-claude.geoffroy@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 22, 2022
• Study Start: December 20, 2022
• Primary Completion: June 20, 2023
• Study Completion: September 23, 2023
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)