Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-01-01 @ 1:55 AM
Study NCT ID:
NCT07147634
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outdoor Science Education and Child Well-being in Primary Schools: Protocol for a Cluster Randomized Controlled Trial on Learning, Connection to Nature, Eco-anxiety, and Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The science education intervention consists of teaching Québec's mandatory science curriculum, focusing on life science topics and issues."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-08-15', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on the Scientific Observation Skills Rubric (0-25) in a Novel Environmental Context', 'timeFrame': 'After the 5-week intervention has ended, students will spend one day in a new environmental context (at the end of October) in order to make observations', 'description': "Students' scientific observation skills will be assessed with a standardized observation rubric designed for elementary science education. After the 5-week intervention, each student will spend one day in a new environmental context (field activity at the end of October). Students will be asked to make a total of 5 oral observations of living organisms in this setting. Independent raters, trained in the use of the rubric, will evaluate the level of complexity of each scientific observation, by assigning a score ranging from 0 (lowest) to 5 (highest quality of scientific observation). The total score will range between 0 to 25 (highest). Higher scores indicate stronger scientific observation skills. Inter-rater agreement will be monitored to ensure reliability."}], 'secondaryOutcomes': [{'measure': 'Connection to nature - Score on the Inclusion of Nature in Self Scale (0-7)', 'timeFrame': 'At baseline and immediately after the 5-week intervention has ended', 'description': "Students' connection to nature will be assessed using the Inclusion of Nature in Self Scale (Schultz, 2001, as used in Braun \\& Dierkes, 2016), a validated 1-item self-report questionnaire appropriate for culturally and ethnically diverse samples of children. The item is rated on a 7-point scale (1 = nature and self do not overlap at all to 7 = nature and self completely overlap). The total score ranges from 0 to 7, with higher scores indicating a stronger subjective connection to nature. The Inclusion of Nature in Self Scale will be administered at baseline and again immediately after the 5-week intervention."}, {'measure': 'Score on the Perceived Stress Scale for Children (PSS-C; range 0-39)', 'timeFrame': 'At baseline and immediately after the 5-week intervention has ended', 'description': "Students' perceived stress will be assessed using the Perceived Stress Scale for Children (PSS-C), which is a standardized 13-item self-report questionnaire previously tested on a sample of Canadian children (White, 2014). Each item is rated on a 4-point Likert scale (0 = never to 3 = a lot). Scores are summed to produce a total ranging from 0 to 39, with higher scores indicating greater perceived stress. The questionnaire will be administered in class at baseline and immediately after the 5-week intervention."}, {'measure': 'Score on the 11-item Hogg Eco-Anxiety Scale (HEAS-13; range 0-33)', 'timeFrame': 'At baseline and immediately after the 5-week intervention has ended', 'description': "Students' eco-anxiety will be assessed using the Hogg Eco-Anxiety Scale (HEAS-13; Hogg et al., 2021), a validated 11-item self-report questionnaire. Each item is rated on a 4-point Likert scale (0 = never to 3 = almost every day). Scores are summed to produce a total ranging from 0 to 33, with higher scores indicating greater subjective feelings of eco-anxiety. The HEAS-13 will be administered in class at baseline and immediately after the 5-week intervention."}, {'measure': 'Score on the Basic Psychological Needs Satisfaction Scale - School Version (range 0-36)', 'timeFrame': 'Baseline and immediately after the 5-week intervention', 'description': "Students' satisfaction of the three basic psychological needs identified by Self-Determination Theory (autonomy, competence, and relatedness) will be assessed with a 9-item version of the Basic Psychological Needs Satisfaction Scale, adapted for children. Each item is rated on a 5-point Likert scale (0 = almost never to 4 = almost always). Total scores range from 0 to 36, with higher scores indicating greater satisfaction of basic psychological needs."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stress', 'School-Based Intervention', 'Cluster Randomized Controlled Trial', 'Primary School', 'Connection to Nature', 'Eco-anxiety', 'Science Learning', 'Outdoor Education'], 'conditions': ['Healthy Children']}, 'descriptionModule': {'briefSummary': "The goal of this randomized controlled trial is to learn if an outdoor science education intervention can improve primary school students' learning and well-being when compared to an indoor classroom-based science education intervention. The main questions it aims to answer are:\n\n* Will students who engage in outdoor science learning produce higher-quality observations of living organisms than students who receive instruction exclusively in an indoor, classroom-based context, when both groups are invited to make observations in an unfamiliar natural environment?\n* Does an outdoor education intervention embedded within the science curriculum contribute to children's connection to nature, eco-anxiety and stress?\n\nParticipants will:\n\n* Receive a science education intervention 2h/week for a total of 5 weeks, either indoors or outdoors\n* Answer questionnaires before and after the intervention\n* Participate in a field day-trip after the intervention where they will be asked to observe living organisms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary schools need to have a deprivation index equal to or superior to 1 (with 10 being the maximum) and be located in Montreal, Longueuil or Laval (QC).\n* Teachers have to show some interest in outdoor education but are not obliged to have already done some before in order to be included.\n* Only 5th and 6th grade teachers are included.\n* Primary schools with two teachers interested in participating in the project.\n\nExclusion Criteria:\n\n* Alternative schools or those welcoming recently arrived non-Francophone students are not included.'}, 'identificationModule': {'nctId': 'NCT07147634', 'acronym': 'Bio-Explo', 'briefTitle': 'Outdoor Science Education and Child Well-being in Primary Schools: Protocol for a Cluster Randomized Controlled Trial on Learning, Connection to Nature, Eco-anxiety, and Stress', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Outdoor Science Education and Child Well-being in Primary Schools: Protocol for a Cluster Randomized Controlled Trial on Learning, Connection to Nature, Eco-anxiety, and Stress', 'orgStudyIdInfo': {'id': '2023-3453'}, 'secondaryIdInfos': [{'id': '435-2022-0651', 'type': 'OTHER_GRANT', 'domain': 'Social Sciences and Humanity Research Council (Canada)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Outdoor science education', 'description': "2h of outdoor science education intervention per week for a total of 5 weeks (following Québec's mandatory curriculum)", 'interventionNames': ['Behavioral: Outdoor science education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Indoor classroom-based science education', 'description': "2h of indoor science education intervention per week for a total of 5 weeks (following Québec's mandatory curriculum)", 'interventionNames': ['Behavioral: Indoor classroom-based science education']}], 'interventions': [{'name': 'Outdoor science education', 'type': 'BEHAVIORAL', 'description': "Following Québec's mandatory curriculum, primary school teachers will provide life science lessons 2h/week for a total of 5 weeks in an outdoor setting", 'armGroupLabels': ['Outdoor science education']}, {'name': 'Indoor classroom-based science education', 'type': 'BEHAVIORAL', 'description': "Following Québec's mandatory curriculum, primary school teachers will provide life science lessons 2h/week for a total of 5 weeks inside the classroom", 'armGroupLabels': ['Indoor classroom-based science education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Gabriela Quintela Do Carmo', 'role': 'CONTACT', 'email': 'quig1988@usherbrooke.ca', 'phone': '803-477-7554'}], 'facility': 'Greater Montreal area (Laval, Longueuil, Montreal)', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Gabriela Quintela Do Carmo', 'role': 'CONTACT', 'email': 'quig1988@usherbrooke.ca', 'phone': '803-477-7554'}, {'name': 'Jean-Philippe Ayotte-Beaudet', 'role': 'CONTACT', 'email': 'jean-philippe.ayotte-beaudet@usherbrooke.ca', 'phone': '514-999-6647'}], 'overallOfficials': [{'name': 'Jean-Philippe Ayotte-Beaudet, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to ethical considerations and to protect participant confidentiality, no de-identified individual participant data will be made available. Only aggregate results will be published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jean-Philippe Ayotte-Beaudet', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}