Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-08 @ 7:52 PM
Study NCT ID:
NCT02258633
Status:
COMPLETED
Last Update Posted:
2014-10-07
First Post:
2014-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Seatbelt Intervention Study
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': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-06', 'studyFirstSubmitDate': '2014-10-02', 'studyFirstSubmitQcDate': '2014-10-06', 'lastUpdatePostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seat belt use', 'timeFrame': '1 month', 'description': 'Follow up telephone assessment on full time seat belt use by parent and child'}, {'measure': 'Seat belt knowledge', 'timeFrame': '1 month', 'description': 'Follow up telephone assessment on level of knowledge of seat belt use and risk factors'}, {'measure': 'Attitudes', 'timeFrame': '1 month', 'description': 'Follow up telephone assessment of positive attitude, motivation, and self-efficacy regarding safety restraint use.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['High Risk Population of Part-time Seatbelt Users']}, 'descriptionModule': {'briefSummary': 'The study will use a randomized controlled design testing the effectiveness of the following intervention: (i) intervener brief intervention (IBI) vs. (ii) Enhanced usual care (EUC). The study will identify children ages 2-14 at a pediatric trauma center. Children and their parents who agree to participate in the study will then complete a screening survey to identify part time seatbelt use. Those who screen positive will complete a more detailed baseline survey and then be randomized to one of two study conditions. At one month, a follow up assessment by telephone will be completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children ages 7-14 and their parent or guardian, at a pediatric trauma center\n* Child admitted to hospital with diagnosis of injury other than sexual assault and suicide\n* Identify as part time seat belt users\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02258633', 'briefTitle': 'The Seatbelt Intervention Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'A Brief Tailored Family-centered Seatbelt Intervention for Hospitalized Trauma', 'orgStudyIdInfo': {'id': 'HUM00026025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervener Brief Intervention (IBI)', 'description': 'Subjects and parents will complete a Brief Motivational Interview (BMI) incorporating personalized feedback, discussion of choices and changes, and therapist led intervention message relating behavioral change and future goals.', 'interventionNames': ['Other: Interactive interview and tailored family centered seatbelt safety intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Enhanced Usual Care', 'description': 'Subjects and parents will receive standard trauma care, plus complete brief questionnaires and receive general safety information.'}], 'interventions': [{'name': 'Interactive interview and tailored family centered seatbelt safety intervention', 'type': 'OTHER', 'armGroupLabels': ['Intervener Brief Intervention (IBI)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Principal Investigator', 'investigatorFullName': 'Peter Ehrlich', 'investigatorAffiliation': 'University of Michigan'}}}}