Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-01-01 @ 1:02 PM
Study NCT ID:
NCT05290103
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2022-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Early Adolescent Non-smoking With a Game Intervention Supporting Self-efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 781}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2022-03-10', 'studyFirstSubmitQcDate': '2022-03-21', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in smoking refusal self-efficacy', 'timeFrame': 'At baseline, at 2 weeks, and at 3 months', 'description': 'Assessed with a smoking refusal self-efficacy scale (scores 6-24; higher scores indicate stronger smoking refusal self-efficacy).'}], 'secondaryOutcomes': [{'measure': 'Change in sources of refusal self-efficacy related to tobacco use', 'timeFrame': 'At baseline, at 2 weeks, and at 3 months', 'description': 'Subscales for cigarette use (7 items) and snus use (7 items). Both are assessed with a 4-point Likert-scale questionnaire.'}, {'measure': 'Change in motivation to decline tobacco use in the future', 'timeFrame': 'At baseline, at 2 weeks, and at 3 months', 'description': 'Subscales for cigarette use and snus use. Both are assessed with a 4-point Likert-scale questionnaire (scores 1-4, lower scores indicate stonger motivation to decline tobacco use in future).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Self Efficacy', 'Smoking']}, 'descriptionModule': {'briefSummary': 'This intervention study evaluates the effectiveness of a digital game intervention supporting smoking refusal self-efficacy among early adolescents (10-13 y). The participants are randomly allocated to two groups: the experimental group that receives the digital game intervention, and the control group that receives no intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Goes to school at 4th, 5th, or 6th grade\n* Sufficient skills in Finnish or Swedish\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05290103', 'briefTitle': 'Promoting Early Adolescent Non-smoking With a Game Intervention Supporting Self-efficacy', 'organization': {'class': 'OTHER', 'fullName': 'University of Turku'}, 'officialTitle': 'Promoting Early Adolescent Non-smoking With a Game Intervention Supporting Self-efficacy', 'orgStudyIdInfo': {'id': 'PEANS2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Game intervention', 'description': 'Participants in this arm will receive the game intervention including 15-30 minutes of digital health game playing at school and 2 weeks of free usage of the game during free time and a 30-minute debriefing session with a researcher.', 'interventionNames': ['Behavioral: Game intervention']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'The participants in this arm will receive no intervention.'}], 'interventions': [{'name': 'Game intervention', 'type': 'BEHAVIORAL', 'description': 'Game intervention consists of 15-30 minutes digital health game playing at school and 2 weeks free usage of the digital health game during free time. In addition, after the 2 weeks period of game playing, 30-minute debriefing sessions with a research are held.\n\nThe digital health game includes visualized elements with sound effects that aim at increasing understanding about the consequences of tobacco product use and supporting refusal skills. The health game includes different mini-games and also textual information.\n\nThe debriefing sessions with a researcher include small group and group discussions about the themes presented in the game. A researcher leads and teachers facilitate the discussions. The debriefing sessions aim to connect the game experience with daily life situations.', 'armGroupLabels': ['Game intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nine Cities', 'country': 'Finland', 'facility': 'Primary schools (n=15)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turku', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctoral candidate', 'investigatorFullName': 'Johanna Nyman', 'investigatorAffiliation': 'University of Turku'}}}}