Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:10 PM
Study NCT ID:
NCT03854734
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2019-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Healthy, Immunized Communities Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000088823', 'term': 'Vaccination Hesitancy'}], 'ancestors': [{'id': 'D000072758', 'term': 'Vaccination Refusal'}, {'id': 'D016312', 'term': 'Treatment Refusal'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jkraschnewski@pennstatehealth.psu.edu', 'phone': '717-531-8161', 'title': 'Dr. Jennifer Kraschnewski, Professor of Medicine and Public Health Sciences', 'organization': 'Penn State College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We experienced low parent participation in the intervention activities, potentially limiting the effectiveness of the intervention and resulting outcomes.'}}, 'adverseEventsModule': {'timeFrame': 'Due to the nature of the intervention, adverse events were not monitored/assessed.', 'description': 'Due to the nature of the intervention, adverse events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Educational emails about broad health topics to keep control group engaged', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Multi-Component Intervention', 'description': "(1) a community event to raise parental awareness of the importance of vaccination; (2) social marketing to target parents' attitudes and knowledge around vaccinations in the form of educational material\n\nCommunity Event: Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.\n\nEducational Material: Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}, {'units': 'Middle Schools', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Educational emails about broad health topics to keep control group engaged'}, {'id': 'OG001', 'title': 'Multi-Component Intervention', 'description': "(1) a community event to raise parental awareness of the importance of vaccination; (2) social marketing to target parents' attitudes and knowledge around vaccinations in the form of educational material\n\nCommunity Event: Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.\n\nEducational Material: Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants"}], 'classes': [{'title': 'Tetanus, diphtheria, acellular pertussis (Tdap) : Vaccine intention at baseline', 'categories': [{'measurements': [{'value': '74.3', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}]}]}, {'title': 'Tetanus, diphtheria, acellular pertussis (Tdap) : Vaccine intention at follow-up', 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000'}, {'value': '93.0', 'groupId': 'OG001'}]}]}, {'title': 'Meningococcal conjugate vaccine (MCV) : Vaccine intention at baseline', 'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000'}, {'value': '80.5', 'groupId': 'OG001'}]}]}, {'title': 'Meningococcal conjugate vaccine (MCV) : Vaccine intention at follow-up', 'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000'}, {'value': '91.6', 'groupId': 'OG001'}]}]}, {'title': 'Human papillomavirus (HPV) : Vaccine intention at baseline', 'categories': [{'measurements': [{'value': '84.1', 'groupId': 'OG000'}, {'value': '84.4', 'groupId': 'OG001'}]}]}, {'title': 'Human papillomavirus (HPV) : Vaccine intention at follow-up', 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000'}, {'value': '87.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.25', 'groupDescription': 'Analysis for vaccine intention of Tdap', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.'}, {'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.29', 'groupDescription': 'Analysis for vaccine intention of MCV', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.'}, {'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.14', 'groupDescription': 'Analysis for vaccine intention of HPV', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.'}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were assessed at baseline and follow-up at 6 months.', 'description': 'Parental intent to vaccinate their adolescent child with Tdap, MCV, and HPV vaccines, was dichotomized for each vaccine in the survey. Tdap and MCV included the options 1) intention to vaccinate/vaccinated ("plan to get this shot before the first day of 7th grade" or "up-to-date with this shot") or 2) no intention to vaccinate ("no plans to get this shot" or "have or plan to submit an exemption for this shot"). The HPV variable excluded the option "have or plan to submit an exemption for this shot" as vaccine is not required for school entry. Variables (Tdap, MCV, HPV) were compared within and between treatment groups from baseline to 6 mo. follow up with a generalized estimating equations model using the framework of a log-binomial logistic regression model. Risk ratios resulting from these models were used to quantify the magnitude and direction of any significant differences.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Middle Schools', 'denomUnitsSelected': 'Middle Schools', 'populationDescription': '4 middle schools were randomized to either a usual care or multi-component intervention arm. Participants (parents) were assigned to a study arm based on their associated middle school. 30 participants either did not complete the follow up survey (n=27) or did not answer all questions (n=3), as questions were not required. Discrepancies in percentage reporting in the outcomes table below results from inconsistent rates of missingess (range 0-4) across variables (Tdap, MCV, HPV).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Educational emails about broad health topics to keep control group engaged'}, {'id': 'FG001', 'title': 'Multi-Component Intervention', 'description': "(1) a community event to raise parental awareness of the importance of vaccination; (2) social marketing to target parents' attitudes and knowledge around vaccinations in the form of educational material\n\nCommunity Event: Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.\n\nEducational Material: Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '70'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '70'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Schools', 'recruitmentDetails': 'Recruitment occurred between February and September 2019. Participants were recruited through the participating school partner, who distributed a recruitment flyer via email and through social media channels. Participants were also recruited through in-person events at the participating schools, such as chorus concerts and parent-teacher conferences.', 'preAssignmentDetails': 'Four schools were randomized to two arms (intervention vs. control). 502 individuals were assessed for eligibility and 354 were excluded for not meeting inclusion criteria (n=265) or declining to participate (n=89).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Educational emails about broad health topics to keep control group engaged'}, {'id': 'BG001', 'title': 'Multi-Component Intervention', 'description': "(1) a community event to raise parental awareness of the importance of vaccination; (2) social marketing to target parents' attitudes and knowledge around vaccinations in the form of educational material\n\nCommunity Event: Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.\n\nEducational Material: Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.00', 'spread': '9.79', 'groupId': 'BG000'}, {'value': '40.46', 'spread': '8.59', 'groupId': 'BG001'}, {'value': '39.32', 'spread': '9.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender', 'categories': [{'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'No response', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Black/African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'No response', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Relationship Status', 'classes': [{'title': 'Single OR separated OR divorced OR widowed', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'Married OR living with partner', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}, {'title': 'No response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Annual household income', 'classes': [{'categories': [{'title': '≤$40,000', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': '$40,001 - $80,000', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': '>$80,000', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'No Response', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'High School or Less', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Some College', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'College Graduate', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'No response', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Relationship to child', 'classes': [{'categories': [{'title': 'Mother', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'Father', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Guardian/Grandparent', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Grade of child', 'classes': [{'categories': [{'title': '6th', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': '7th', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': '8th', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender of child', 'classes': [{'categories': [{'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parent participation in school events per year', 'classes': [{'categories': [{'title': '≤1', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': '2-5', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': '≥6', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'No response', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-09', 'size': 351766, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-01T08:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Following collection of baseline data, schools will be randomized. Study staff measuring the primary outcome will be blinded to school group assignment. Given the intervention, it is not possible to blind participants to group assignment.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-26', 'studyFirstSubmitDate': '2019-02-20', 'resultsFirstSubmitDate': '2023-03-18', 'studyFirstSubmitQcDate': '2019-02-25', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-26', 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV)', 'timeFrame': 'Participants were assessed at baseline and follow-up at 6 months.', 'description': 'Parental intent to vaccinate their adolescent child with Tdap, MCV, and HPV vaccines, was dichotomized for each vaccine in the survey. Tdap and MCV included the options 1) intention to vaccinate/vaccinated ("plan to get this shot before the first day of 7th grade" or "up-to-date with this shot") or 2) no intention to vaccinate ("no plans to get this shot" or "have or plan to submit an exemption for this shot"). The HPV variable excluded the option "have or plan to submit an exemption for this shot" as vaccine is not required for school entry. Variables (Tdap, MCV, HPV) were compared within and between treatment groups from baseline to 6 mo. follow up with a generalized estimating equations model using the framework of a log-binomial logistic regression model. Risk ratios resulting from these models were used to quantify the magnitude and direction of any significant differences.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaccinations', 'Vaccine hesitancy', 'School-based research'], 'conditions': ['Vaccine Hesitancy', 'Communicable Diseases in Children']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.jvacx.2023.100273', 'label': 'Peer-reviewed manuscript describing primary study outcomes'}]}, 'descriptionModule': {'briefSummary': 'This project aims to understand how improving vaccine education and awareness can impact the number of parents who vaccinate, or intend to vaccine, their middle school-aged children with age-appropriate vaccines, including human papillomavirus (HPV), meningitis (MCV) and tetanus, diphtheria, pertussis (TDap).', 'detailedDescription': "Vaccines are considered one of the greatest public health successes. Unfortunately, an increasing rate of parental resistance in recent years has led to a reemergence of vaccine-preventable diseases. This project seeks to determine the effect of a multi-tiered school and community-based approach to improving rates of parental intent to vaccinate for middle school-aged vaccinations including Human Papillomavirus (HPV), meningitis (MCV) and Tetanus, Diphtheria, Pertussis (TDap).\n\nBy randomizing participating schools, parents receiving the intervention participated in (1) a community-based event to raise parental awareness of the importance of vaccination and (2) a social marketing campaign targeting parents' attitudes and knowledge around vaccinations.\n\nThe Investigators hypothesized that participation in this study would increase parental intention to vaccinate. In addition, this study intended to improve rates of recommended vaccination among middle school-aged children, as measured through vaccine uptake information required for annual entry into Pennsylvania public schools.\n\nThe Penn State team brings a breadth of experience in pediatrics, community-engaged research, adolescent health, and engagement with schools."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* 18 years or older\n* Parents and guardians of children who attend a School District of Lancaster middle schools\n* Individuals who read and understand English\n* Individuals with an email address\n\nExclusion Criteria\n\n* Individuals who are non-English speaking\n* Parents/Guardians \\<18 years or older who do not have children attending a middle school in the School District of Lancaster\n* Individuals who do not have an email address\n* Individuals who plan on moving out of the Lancaster City area in the next year'}, 'identificationModule': {'nctId': 'NCT03854734', 'briefTitle': 'Healthy, Immunized Communities Study', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': "A Randomized Study to Determine the Efficacy of a Multi-tiered Community- and School-based Approach to Enhance School-aged Children's Recommended Vaccinations.", 'orgStudyIdInfo': {'id': 'Study000011289'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Educational emails about broad health topics to keep control group engaged'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multi-Component Intervention', 'description': "(1) a community event to raise parental awareness of the importance of vaccination; (2) social marketing to target parents' attitudes and knowledge around vaccinations in the form of educational material", 'interventionNames': ['Behavioral: Community Event', 'Behavioral: Educational Material']}], 'interventions': [{'name': 'Community Event', 'type': 'BEHAVIORAL', 'description': 'Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.', 'armGroupLabels': ['Multi-Component Intervention']}, {'name': 'Educational Material', 'type': 'BEHAVIORAL', 'description': 'Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants', 'armGroupLabels': ['Multi-Component Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State College of Medicine', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Jennifer Kraschnewski', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "The following steps will be taken to protect subjects' privacy interests: identification and recruitment of potential subjects follows procedures consistent with privacy standards; consent discussion and research interventions will take place in a private setting; the information being collected will be limited to only the minimum amount of data necessary to accomplish the research purposes; the people with access to the identifiable research data will be limited to the minimum necessary as specified in the application and consent process. To external researchers or sponsors, data will be sent sent/received in aggregate/metrics (just counts, no individual data)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jennifer Kraschnewski', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}