Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT06303804
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Opioid Misuse and Overdose Deaths Among Hispanic/Latinx Adolescents: A Family-based Perspective
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of the educational materials presented via the educational videos, including cultural congruence as assessed by a questionnaire', 'timeFrame': 'end of study (Day 7)', 'description': 'This questionnaire has 10 questions that is measured on a Likert scale from 1-4, higher number indicating more acceptability.'}, {'measure': 'Changes in opioid related knowledge as assessed by a questionnaire', 'timeFrame': 'Baseline, end of study (Day 7)', 'description': 'This has 3 subscales\n\n1. Brief Opioid Overdose Knowledge (BOOK)\n\n This has 12 questions and each is scored from 0(true), 1(false) for a maximum score of 12, higher score indicating more knowledge\n2. Opioid Overdose Knowledge Scale (OOKS)\n\n This has 9 questions, and participants have to identify all correct answers. Score ranges from 0(no correct answers) -33 (identified all correct answers) higher score indicates more knowledge\n3. Opioid Overdose Attitude Scale (OOAS)\n\nThis has 28 questions scored on a Likert scale from 1(completely disagree)-5(completely agree), higher number indicating more positive attitude'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Misuse']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop culturally-competent family-focused educational modules targeting opioid knowledge and attitudes (including targeting safe storage and prevention of accidental opioid overdose in adolescent populations) and examine changes acceptability, knowledge, and attitudes scores'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must identify as Hispanic/Latino/a descent\n* Have an adolescent between the ages of 15 and 17 years old living in their home a majority of the time\n* Have English or Spanish proficiency\n\nExclusion Criteria:\n\n* Adolescent or parent currently in opioid treatment\n* Parent self-reports a substance use (including opioid use) disorder for themselves or adolescent'}, 'identificationModule': {'nctId': 'NCT06303804', 'briefTitle': 'Prevention of Opioid Misuse and Overdose Deaths Among Hispanic/Latinx Adolescents: A Family-based Perspective', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Prevention of Opioid Misuse and Overdose Deaths Among Hispanic/Latinx Adolescents: A Family-based Perspective', 'orgStudyIdInfo': {'id': 'HSC-SPH-23-0837'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational videos arm', 'interventionNames': ['Behavioral: Educational videos']}], 'interventions': [{'name': 'Educational videos', 'type': 'BEHAVIORAL', 'description': 'Participants will be delivered a link to complete demographic information and the initial assessment. Upon completing the (initial) pre-test knowledge assessment, participants will be sent links to the three educational videos staggered across 7 days. Educational videos will determine gaps in knowledge related to opioid use and overdose based on questionnaire responses. Upon the completion of the 7 days, participants will be sent a link to the (final) post-test knowledge assessment to complete.', 'armGroupLabels': ['Educational videos arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Alejandra Fernandez, PhD', 'role': 'CONTACT', 'email': 'Alejandra.Fernandez@uth.tmc.edu', 'phone': '972-546-2920'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Alejandra Fernandez, PhD', 'role': 'CONTACT', 'email': 'Alejandra.Fernandez@uth.tmc.edu', 'phone': '(972) 546-2920'}], 'overallOfficials': [{'name': 'Alejandra Fernandez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Alejandra Fernandez', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}