Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT03311061
Status:
UNKNOWN
Last Update Posted:
2017-10-16
First Post:
2017-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Curriculum for Teen Pregnancy Prevention: Decisions, Responsibility, Empowerment, Accountability, Motivations & Success
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Students are masked through'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups of participants. group A will receive the DREAMS Curriculum intervention. Group B (Control group) will receive curriculum already in place at school.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-10', 'studyFirstSubmitDate': '2017-10-10', 'studyFirstSubmitQcDate': '2017-10-10', 'lastUpdatePostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who had sex without a condom', 'timeFrame': 'immediately post-intervention, 6-months and 12-months-post intervention', 'description': 'Number of participants who had sex without a condom. The relative difference of condom usage during penile-vaginal sex acts in the intervention versus control group at post-intervention, 6-months and 12-months post-intervention.'}, {'measure': 'Number of participants who ever had sex', 'timeFrame': 'immediately post-intervention, 6-months and 12-months-post intervention', 'description': 'Number of participants who ever had sex. The relative difference of ever having sex (penile-vaginal sex acts) in the intervention versus control group at post-intervention, 6-months and 12-months post-intervention.'}, {'measure': 'Number of penile-vaginal sex acts', 'timeFrame': 'immediately post-intervention, 6-months and 12-months-post intervention', 'description': 'Number of penile-vaginal sex acts. The relative difference of the number of penile-vaginal sex acts in the intervention versus control group at post-intervention, 6-months and 12-months post-intervention.'}, {'measure': 'Number of participants who used other birth control methods', 'timeFrame': 'immediately post-intervention, 6-months and 12-months-post intervention', 'description': 'Number of participants who used other birth control methods. The relative difference of birth control methods (e.g., the pill, the patch) during penile-vaginal sex acts in the intervention versus control group at post-intervention, 6-months and 12-months post-intervention.'}, {'measure': 'Number of participants who had an STI', 'timeFrame': 'immediately post-intervention, 6-months and 12-months-post intervention', 'description': 'Number of participants who had an STI. The relative difference of reported STI in the intervention versus control group at post-intervention, 6-months and 12-months post-intervention.'}, {'measure': 'Number of participants who increased knowledge concerning risks associated with unprotected sex', 'timeFrame': 'immediately post intervention', 'description': 'Number of participants who increased knowledge concerning risks associated with unprotected sex. The relative difference of knowledge gained in the intervention versus control group at immediately post-intervention.'}], 'secondaryOutcomes': [{'measure': 'Number of participants (by gender, age, and race/ethnicity) who had had a teenage pregnancy', 'timeFrame': '12-months-post intervention', 'description': 'Number of participants (by gender, age, and race/ethnicity) who had had a teenage pregnancy. The relative difference of teenage pregnancies (among genders, ages, and race/ethnicity) in the intervention versus control group at 12-months post-intervention.'}, {'measure': 'Number of participants who had had a teenage pregnancy', 'timeFrame': '12-months-post intervention', 'description': 'Number of participants who had had a teenage pregnancy. The relative difference of teenage pregnancies in the intervention versus control group at 12-months post-intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Teen Pregnancy', 'Prevention', 'Positive Youth Development', 'Financial Literacy', 'College and Career Readiness', 'School Based Intervention', 'Age 13-19', 'Behavior Modification'], 'conditions': ['Teen Pregnancy']}, 'descriptionModule': {'briefSummary': 'The study is a an evaluation of the teen pregnancy prevention curriculum Decisions, Responsibility, Empowerment, Accountability, Motivations \\& Success (DREAMS) through a random control trial. The evaluation will take place in high schools in the greater Houston area. Five cohorts of two classes each in ten HS schools will be used. Randomization will occur each semester for five semesters. Curriculum is ten modules in length delivered in 45 minute classes twice a week for five weeks.', 'detailedDescription': 'The study is a an evaluation of the teen pregnancy prevention curriculum Decisions, Responsibility, Empowerment, Accountability, Motivations \\& Success (DREAMS) through a random control trial. The evaluation will take place in high schools in the greater Houston area. Five cohorts of two classes each in ten HS schools will be used. Randomization will occur each semester for five semesters. Curriculum is ten modules in length delivered in 45 minute classes twice a week for five weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 13-19; enrolled in participating high school health class; passive consent received;\n\nExclusion Criteria:\n\nStudents who enrolled in classes post baseline. Students who had previously failed the HS course and was already exposed to DREAMS curriculum.'}, 'identificationModule': {'nctId': 'NCT03311061', 'acronym': 'DREAMS', 'briefTitle': 'Evaluation of Curriculum for Teen Pregnancy Prevention: Decisions, Responsibility, Empowerment, Accountability, Motivations & Success', 'organization': {'class': 'OTHER', 'fullName': 'Winter Rose Services, LLC'}, 'officialTitle': 'Evaluation of Curriculum for Teen Pregnancy Prevention: Decisions, Responsibility, Empowerment, Accountability, Motivations & Success (DREAMS) in Houston TX', 'orgStudyIdInfo': {'id': '00004955'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DREAMS', 'description': 'The experimental group will be exposed to the DREAMS curriculum including the supplemental technology based application.It is composed of 10 modules: Introduction; Self Exploration; Healthy Relationships; Adolescent Sexuality; Attitudes and Adolescent Sexual Activity; Consequences of Sex - HIV/STI; Consequences of Sex - Pregnancy; Managing Pressure to Engage in Sexual Activity through the Lens of Social Media; Financial Literacy; Careers; Post secondary Education; Wrap up and Close Out.\n\nThe technology app will include curriculum support and additional resources.\n\nStudents will have access to the mobile app after the in school programming ends. The intent is for students to have access to portions of the app that deal with self developed goals and progress monitoring for goals, and resource material. This is similar to a student having continued access to a textbook/other class materials.', 'interventionNames': ['Other: DREAMS Curriculum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non DREAMS', 'description': 'The control group experience will include health curriculum already adopted by the school district. Continued services as usual. The control group schools, for the most part, lack any formal pregnancy prevention services. All schools claim that lessons developed by the teachers meet the Texas Essential Knowledge Standards (TEKS). No outside services are provided to students and school based services are limited. The services offered at the schools is predominately abstinence based. Students attending the schools would need to initiate any services that are available within the community. The control group will not have access to the DREAMS curriculum or the technology-based application to enhance the DREAMS curriculum. The technology-based application will be a closed, password protected, system during the research trial.', 'interventionNames': ['Other: DREAMS Curriculum']}], 'interventions': [{'name': 'DREAMS Curriculum', 'type': 'OTHER', 'description': 'Teen Pregnancy Prevention Curriculum as described in arm/group description.', 'armGroupLabels': ['DREAMS', 'Non DREAMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77036', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Bee Busy Inc.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Winter Rose Services, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Health and Human Services', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CEO', 'investigatorFullName': 'Dawn Marie Baletka', 'investigatorAffiliation': 'Winter Rose Services, LLC'}}}}