Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-30 @ 6:24 PM
Study NCT ID:
NCT02178332
Status:
COMPLETED
Last Update Posted:
2021-12-13
First Post:
2014-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yhteispeli - Effectiveness Study on Promoting Childrens' Socio-emotional Skills in School
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2015-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-29', 'studyFirstSubmitDate': '2014-04-03', 'studyFirstSubmitQcDate': '2014-06-26', 'lastUpdatePostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in teacher and parent interaction', 'timeFrame': '6 months after baseline and 18 months after baseline', 'description': 'A set of teacher-parent interaction tests'}, {'measure': "Change in children's and teachers' perceptions of class environment", 'timeFrame': '6 months after baseline and 18 months after baseline', 'description': 'A set of class environment questions rated by the teacher and children'}, {'measure': 'Change in teaching and parenting styles', 'timeFrame': '6 months after baseline and 18 months after baseline', 'description': 'A set of questions regarding child rearing'}, {'measure': "Change in teachers' and parents' socio-emotional skills", 'timeFrame': '6 months after baseline and 18 months after baseline', 'description': 'A set of questions regarding adult socio-emotional skills'}], 'primaryOutcomes': [{'measure': "Change in children's psychiatric symptoms", 'timeFrame': '6 months after baseline and 18 months after baseline', 'description': 'SDQ - The Strengths and Difficulties Questionnaires'}, {'measure': "Change in children's socio-emotional skills", 'timeFrame': '6 months after baseline and 18 months after baseline', 'description': 'A set of socio-emotional skills tests A set of questions regarding bullying'}], 'secondaryOutcomes': [{'measure': "Change in children's emotion recognition (and processing)", 'timeFrame': '6 months after baseline and 18 months after baseline', 'description': 'A set of emotion recognition (and processing) tests'}, {'measure': "Change in children's executive functions", 'timeFrame': '6 months after baseline and 18 months after baseline', 'description': 'A set of cognitive functions tests'}, {'measure': 'Change in teacher and work community (occupational) wellbeing', 'timeFrame': '6 months after baseline and 18 months after baseline', 'description': "A set of teacher's occupational and work community wellbeing tests"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Children', 'socio-emotional', 'socio-emotional skills', 'psychiatric symptoms', 'SDQ', 'Finland', 'School', 'School community', 'Teacher', 'Whole school approach', 'Intervention', 'Effectiveness study', 'Cluster randomised trial'], 'conditions': ["Children's Socio-emotional Skills and Psychiatric Symptoms"]}, 'referencesModule': {'references': [{'pmid': '25287298', 'type': 'BACKGROUND', 'citation': 'Bjorklund K, Liski A, Samposalo H, Lindblom J, Hella J, Huhtinen H, Ojala T, Alasuvanto P, Koskinen HL, Kiviruusu O, Hemminki E, Punamaki RL, Sund R, Solantaus T, Santalahti P. "Together at school"--a school-based intervention program to promote socio-emotional skills and mental health in children: study protocol for a cluster randomized controlled trial. BMC Public Health. 2014 Oct 7;14:1042. doi: 10.1186/1471-2458-14-1042.'}, {'pmid': '27230903', 'type': 'RESULT', 'citation': 'Kiviruusu O, Bjorklund K, Koskinen HL, Liski A, Lindblom J, Kuoppamaki H, Alasuvanto P, Ojala T, Samposalo H, Harmes N, Hemminki E, Punamaki RL, Sund R, Santalahti P. Short-term effects of the "Together at School" intervention program on children\'s socio-emotional skills: a cluster randomized controlled trial. BMC Psychol. 2016 May 26;4(1):27. doi: 10.1186/s40359-016-0133-4.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this cluster randomised trial is to investigate whether the Yhteispeli whole school programme is effective in improving children's socio-emotional skills and mental health and socio-emotional skills.\n\nAll Finnish elementary schools and their classes in 1-3 grades were invited to participate in the study. The schools were randomly allocated to receive either Yhteispeli programme or two lectures"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children from volunteering elementary schools and classes (grades 1 to 3) whose parents gave consent to participate\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02178332', 'briefTitle': "Yhteispeli - Effectiveness Study on Promoting Childrens' Socio-emotional Skills in School", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Finnish Institute for Health and Welfare'}, 'officialTitle': "Yhteispeli: Intervention Effectiveness on Elementary School Childrens' Socio-emotional Skills and Psychiatric Symptoms", 'orgStudyIdInfo': {'id': 'THL/455/6.00.00/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yhteispeli, whole school programme', 'description': "Yhteispeli-programme aims to support children's socio-emotional skills and well being at schools. Schools receive the Yhteispeli manual and teachers receive 3 and head masters 2 lecture days about use of Yhteispeli methods including group discussions and exercises. In addition every school is visited 4 times to support the use of Yhteispeli methods. (Lectures for the head masters March 2013 - November 2013, teachers August 2013 - January 2014)", 'interventionNames': ['Other: Yhteispeli, whole school programme']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Two theoretical lectures', 'description': "Teachers receive two theoretical lectures on development of children's socio-emotional skills (3 hours in November 2013 and 3 hours in March 2014 ).", 'interventionNames': ['Other: Two theoretical lectures']}], 'interventions': [{'name': 'Yhteispeli, whole school programme', 'type': 'OTHER', 'armGroupLabels': ['Yhteispeli, whole school programme']}, {'name': 'Two theoretical lectures', 'type': 'OTHER', 'armGroupLabels': ['Two theoretical lectures']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Olli Kiviruusu', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Olli Kiviruusu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Finnish Institute for Health and Welfare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Finnish Institute for Health and Welfare', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Tampere University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Manager', 'investigatorFullName': 'Olli Kiviruusu', 'investigatorAffiliation': 'Finnish Institute for Health and Welfare'}}}}