Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT03212066
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2017-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Master Mind Program Evaluation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 518}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-06', 'studyFirstSubmitDate': '2017-07-05', 'studyFirstSubmitQcDate': '2017-07-06', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in score on Positive and Negative Affect Scale for Children - Shortened Version (PANAS)', 'timeFrame': '6 weeks', 'description': "Assesses students' experiences of positive and negative emotions."}, {'measure': 'Change in score on Self-Report Coping Measure', 'timeFrame': '6 weeks', 'description': "Assesses students' coping in response to stressors."}, {'measure': 'Change in score on Intentions to use alcohol or tobacco', 'timeFrame': '6 weeks', 'description': "Assesses students' intentions to use alcohol or tobacco in the future."}, {'measure': 'Change in score on Willingness to use alcohol or tobacco', 'timeFrame': '6 weeks', 'description': "Assesses students' willingness to use alcohol or tobacco by responding to imagined situations."}, {'measure': 'Change in score on The Peer Relations questionnaire', 'timeFrame': '6 weeks', 'description': "Assesses students' feelings about their classmates."}, {'measure': 'Change in score on The Emotional Self-Efficacy Scale for Youth', 'timeFrame': '6 weeks', 'description': "Assesses students' beliefs about their ability to manage emotions."}, {'measure': 'Change in scores on Flanker Inhibitory Control and Attention Test', 'timeFrame': '6 weeks', 'description': "Assesses students' executive functioning skills via a performance task."}, {'measure': 'Change in score on Childhood Executive Functioning Inventory (CHEXI)', 'timeFrame': '6 weeks', 'description': "Assesses teacher ratings of students' executive functioning."}, {'measure': 'Change in score on The Child Behavior Scale (CBS)', 'timeFrame': '6 weeks', 'description': 'Assesses teacher ratings of student behavior and peer relationships.'}, {'measure': 'Change in Iowa Conners Teacher Rating Scale', 'timeFrame': '6 weeks', 'description': "Assesses teacher ratings of students' inattention and aggression."}, {'measure': 'Change in Iowa Conners Teacher Rating Scale', 'timeFrame': '14 weeks', 'description': "Assesses teacher ratings of students' inattention and aggression."}, {'measure': 'Change in Student grades', 'timeFrame': '6 weeks', 'description': 'Teachers will be asked to provide grades for each student for Math and Language Arts.'}, {'measure': 'Change in Student grades', 'timeFrame': '14 weeks', 'description': 'Teachers will be asked to provide grades for each student for Math and Language Arts.'}], 'secondaryOutcomes': [{'measure': 'Student Consumer Satisfaction Questionnaire', 'timeFrame': '6 weeks', 'description': 'Assesses the overall opinions of students in the intervention group about the Master Mind lessons and activities.'}, {'measure': 'Teacher Program Feasibility Questionnaire', 'timeFrame': '6 weeks', 'description': 'Assesses the overall opinions of teachers in the intervention group related to feasibility of the Master Mind program.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Substance Abuse', 'Mindfulness']}, 'referencesModule': {'references': [{'pmid': '27057208', 'type': 'BACKGROUND', 'citation': 'Parker AE, Kupersmidt JB, Mathis ET, Scull TM, Sims C. The impact of mindfulness education on elementary school students: Evaluation of the Master Mind Program. Adv Sch Ment Health Promot. 2014;7(3):184-204. doi: 10.1080/1754730X.2014.916497. Epub 2014 May 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a randomized controlled trial to evaluate the efficacy of the Master Mind program, a mindfulness education substance abuse prevention program. The program has the goal of enhancing coping strategies and decision-making skills and preventing substance abuse in late elementary school students.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English Fluency\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03212066', 'acronym': 'MasterMind', 'briefTitle': 'Master Mind Program Evaluation Study', 'organization': {'class': 'OTHER', 'fullName': 'Innovation Research & Training'}, 'officialTitle': 'Elementary School Mindfulness-Based Substance Use Prevention Program', 'orgStudyIdInfo': {'id': 'R44AA021342', 'link': 'https://reporter.nih.gov/quickSearch/R44AA021342', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R44AA021342', 'link': 'https://reporter.nih.gov/quickSearch/R44AA021342', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Master Mind is a 25-lesson elementary school, mindfulness education substance abuse prevention program for 4th and 5th grade classrooms.', 'interventionNames': ['Behavioral: Master Mind']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-List Control', 'description': 'Business as usual'}], 'interventions': [{'name': 'Master Mind', 'type': 'BEHAVIORAL', 'description': 'Master Mind is a 25-lesson elementary school mindfulness education substance abuse prevention program. Each lesson takes approximately 15 minutes and is designed to be taught by trained teachers every day for 5 weeks.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27713', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'innovation Research & Training', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Alison Parker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Innovation Research & Training'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovation Research & Training', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}