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Intervention group for Childhood Behavior

N/A
Waitlist Available
Led By Marie-Claude Geoffroy, PhD
Research Sponsored by McGill University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months
Awards & highlights

Study Summary

This trial will test the effectiveness of an outdoor nature-based intervention to reduce mental health problems among 2500 6th grade children and 100 teachers in Quebec, Canada.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline Child Mental Health at 3 months
Secondary outcome measures
Change from Baseline Child Connection with Nature at 3 Months
Change from Baseline Child Connection with Nature at 6 Months
Change from Baseline Child Depressive Symptoms at 6 months
+16 more
Other outcome measures
Adherence Assessments: Teacher Logbook

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 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.

Find a Location

Who is running the clinical trial?

McGill UniversityLead Sponsor
395 Previous Clinical Trials
996,877 Total Patients Enrolled
Observatory for Children's Education and HealthUNKNOWN
Marie-Claude Geoffroy, PhDPrincipal InvestigatorMcGill
1 Previous Clinical Trials
47 Total Patients Enrolled

Media Library

Open Sky School program Clinical Trial Eligibility Overview. Trial Name: NCT05662436 — N/A
Childhood Behavior Research Study Groups: Control, Intervention group
Childhood Behavior Clinical Trial 2023: Open Sky School program Highlights & Side Effects. Trial Name: NCT05662436 — N/A
Open Sky School program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05662436 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any additional participants being accepted into this research program?

"Based on clinicaltrials.gov's records, this medical trial is not looking for participants at present; the posting dates from December 20th 2022 to December 14th 2022 support this assertion. However, there are currently 40 other trials that do require patient recruitment."

Answered by AI
~1071 spots leftby May 2025