Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-02 @ 7:54 AM
Study NCT ID:
NCT03170635
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2017-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Refreshing Recess: Staff and Student Feedback Outcome Study (EMCRR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The Refreshing Recess program was provided one day/week for 6 consecutive weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 485}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-26', 'studyFirstSubmitDate': '2017-05-19', 'studyFirstSubmitQcDate': '2017-05-26', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Changes in students' participation and enjoyment of recess play and socialization", 'timeFrame': 'pretest prior to the program implementation (10 minutes) and posttest 6 weeks later after program implementation (10 minutes)', 'description': 'Visual analogue survey'}], 'secondaryOutcomes': [{'measure': 'Changes in recess supervisors knowledge, beliefs, and actions related to supervising recess', 'timeFrame': 'pre-survey prior to program implementation (10 min.) and post-survey following the 6 week program (10 min.)', 'description': 'Likert scale survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recess, occupational therapy'], 'conditions': ['Interpersonal Relations', 'Occupational Therapy']}, 'descriptionModule': {'briefSummary': 'A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led Refreshing Recess program designed to build capacity of recess supervisors to create a positive recess experience so that all students can successfully participate in and enjoy active play and socialization with peers.', 'detailedDescription': 'A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led Refreshing Recess program designed to build capacity of recess supervisors to create a positive mealtime environment so that all students can successfully participate in and enjoy recess and socialization with peers. Occupational therapy practitioners provide weekly information and coaching to recess supervisors and embed weekly activities into the recess experience (e.g. team building games, strategies for including students with disabilities, etc.).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all kindergarten through 4th grade students in school where the Refreshing Recess program was offered based on principal approval\n* all recess supervisors who supervised recess during program implementation\n\nExclusion Criteria:\n\n\\- students who did not receive the school-sponsored Refreshing Recess program'}, 'identificationModule': {'nctId': 'NCT03170635', 'acronym': '(EMCRR)', 'briefTitle': 'Refreshing Recess: Staff and Student Feedback Outcome Study (EMCRR)', 'organization': {'class': 'OTHER', 'fullName': 'Cleveland State University'}, 'officialTitle': 'The Refreshing Recess Program for Promoting Student Participation and Enjoyment: An Outcome Study', 'orgStudyIdInfo': {'id': '29788-BAZ-HS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '6 week Refreshing Recess program', 'description': 'Education and coaching for recess supervisors to learn about how to promote positive social interaction and active play with all students during recess. Provision of play activities for students during recess that foster active play, teamwork, and inclusion of students with disabilities and/or social challenges.', 'interventionNames': ['Behavioral: Refreshing Recess program']}], 'interventions': [{'name': 'Refreshing Recess program', 'type': 'BEHAVIORAL', 'description': '6-week program integrated into recess in order to build capacity of recess supervisors to foster active play and socialization so that all students enjoy recess and socialization with peers.', 'armGroupLabels': ['6 week Refreshing Recess program']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Susan Bazyk', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cleveland State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Occupational Therapy', 'investigatorFullName': 'Susan Bazyk', 'investigatorAffiliation': 'Cleveland State University'}}}}