Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-03-06 @ 10:55 PM
Study NCT ID:
NCT01369394
Status:
COMPLETED
Last Update Posted:
2014-12-10
First Post:
2011-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Making Decisions About the Measles-Mumps-Rubella Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008457', 'term': 'Measles'}, {'id': 'D009107', 'term': 'Mumps'}, {'id': 'D012409', 'term': 'Rubella'}], 'ancestors': [{'id': 'D018185', 'term': 'Morbillivirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D019351', 'term': 'Rubulavirus Infections'}, {'id': 'D010309', 'term': 'Parotitis'}, {'id': 'D010305', 'term': 'Parotid Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018355', 'term': 'Rubivirus Infections'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-08', 'studyFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2011-06-07', 'lastUpdatePostDateStruct': {'date': '2014-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Parent's intention to vaccinate child against MMR", 'timeFrame': 'Date of intervention (one day)', 'description': 'Parent will rate his/her intention to have child vaccinated against MMR using a Likert scale before and after the intervention.'}], 'secondaryOutcomes': [{'measure': 'Use of the intervention', 'timeFrame': 'At the time of intervention participation', 'description': 'We will assess the number of pages viewed and time spend per page for each participant viewing the intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Measles', 'Mumps', 'Rubella', 'MMR', 'Prevention', 'Tailoring', 'Persuasive communication', 'Children'], 'conditions': ['Measles', 'Mumps', 'Rubella', 'MMR Vaccination']}, 'descriptionModule': {'briefSummary': "The goal of this study is to determine whether a computer-based intervention that delivers individually-tailored educational messages about the MMR vaccine increases MMR vaccine-hesitant parents' intentions to have their children vaccinated.", 'detailedDescription': "This will be a randomized controlled intervention trial for MMR vaccine-hesitant parents of children ages six years and younger who have not yet received the MMR vaccine. Parents will complete a three-item measure that assesses their baseline intentions for having their children vaccinated with MMR. Participants will then fill out a short, computer-based survey that assesses demographic factors, prior experience with MMR, and views about a variety of potential barriers to MMR vaccination. Following the survey, the intervention group (40 parents) will view a series of tailored educational messages resembling web pages that uses their survey data to address at an individual level their specific concerns about the MMR vaccine. The control group (40 parents) will view a series of generic educational messages resembling web pages that is similar in appearance to the intervention, but contains only untailored information about the vaccine. After navigating through these educational messages, MMR vaccination intention will be reassessed using the same three-item measure as for the baseline assessment of vaccination intention. The vaccine administration records of the children of these parents will be accessed after parents' participation in the study to assess whether the MMR vaccine was provided to the child."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent is greater than or equal to 18 years of age\n* Parent has a child 6 years of age or younger\n* When asked to describe how he/she feels about getting child vaccinated against MMR, parent responds "I don\'t want to get my child vaccinated" or "I\'m unsure if I want my child to get vaccinated"\n\nExclusion Criteria:\n\n* Cannot read/speak English'}, 'identificationModule': {'nctId': 'NCT01369394', 'briefTitle': 'Making Decisions About the Measles-Mumps-Rubella Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Developing a Computer-based Intervention That Provides Individually-tailored Educational Information for MMR Vaccine-hesitant Parents', 'orgStudyIdInfo': {'id': '186564'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailored information', 'description': 'Individuals assigned to the experimental group will receive individually-tailored educational messages.', 'interventionNames': ['Other: Behavioral: Computer-based tailoring system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Untailored information', 'description': 'Individuals assigned to the control group will receive generic, untailored educational messages.', 'interventionNames': ['Other: Behavioral: Computer-based tailoring system']}], 'interventions': [{'name': 'Behavioral: Computer-based tailoring system', 'type': 'OTHER', 'description': 'Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will generate educational messages based on participants\' responses to survey questions. The intervention group will receive tailored educational messages, whereas the control group will receive generic educational messages. The tailored and generic educational messages will be presented as to look like web pages. However, the messages will only exist on the study computer, and will not be linked to any "live" server or website.', 'armGroupLabels': ['Tailored information', 'Untailored information']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'UMHS Outpatient Pediatrics', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Amanda Dempsey, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Outcomes Research Program"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Amanda Dempsey', 'investigatorAffiliation': 'University of Colorado, Denver'}}}}