NCT05662436

Protocol for the Open Sky School

Status unknown NA Last updated 22 December 2022

What this trial tests

NA trial testing Open Sky School program in Child Behavior in 2,500 participants. Status unknown.

Timeline

20 December 2022

Primary endpoint
20 June 2023

23 September 2023

Quick facts

Lead sponsor	McGill University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	2,500
Start date	20 December 2022
Primary completion	20 June 2023
Estimated completion	23 September 2023
Sites	1 location across Canada

Drugs / interventions tested

• Open Sky School program

Conditions studied

• Child Behavior — all drugs for Child Behavior →

Sponsor

McGill University

Who can join

Eligibility, any sex, with Child Behavior. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Nature-Based Intervention and Mental Health of Schoolchildren: A Cluster Randomized Clinical Trial.
   Loose T, Fuoco J, Malboeuf-Hurtubise C, Ayotte-Beaudet JP, et al · · 2024 · cited 6× · PMID 39546315 · DOI 10.1001/jamanetworkopen.2024.44824
2. 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.
   Loose T, Côté S, Malboeuf-Hurtubise C, Beaudet JA, et al · · 2023 · cited 2× · PMID 36737725 · DOI 10.1186/s12889-023-15033-y