Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-27 @ 3:14 AM
Study NCT ID:
NCT06576193
Status:
RECRUITING
Last Update Posted:
2025-10-30
First Post:
2024-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empowering Young Parents: Building Healthy Relationships Study
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': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Field Data Collectors (FDCs) will be masked to the participant group assignments until after the baseline data collection is completed.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Individual AYA will be block-randomized to the SDYP intervention with standard prenatal and post-partum services (intervention condition) or standard services only (control condition) using a 1:1 allocation within each site (stratified randomization) to ensure balanced assignment, using permuted blocks sizes of 4 and 6.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Condomless vaginal or anal sex (Month 12)', 'timeFrame': 'Three months, Twelve months', 'description': 'Participant-reported condom use at recalled instances of vaginal or anal sex over the past 3 months and at 12 months follow-up using a standard, self-administered questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Condomless vaginal or anal sex (Month 6)', 'timeFrame': 'Three months, Six months', 'description': 'Participant-reported condom use at recalled instances of vaginal or anal sex over the past 3 months and at 6 months follow-up visit using a standard, self-administered questionnaire.'}, {'measure': 'Sexual and Reproductive Coercion', 'timeFrame': 'Month 12', 'description': 'Participant-reported occurrence of sexual and reproductive coercion with their primary or recent sexual partner at study Month 12 using a 5-point Likert scale questionnaire.'}, {'measure': 'Negotiation of condom use and contraception', 'timeFrame': 'Month 6', 'description': 'Participant-reported ability to successfully negotiate condom and contraceptive-use with their primary or recent sexual partner at study Month 6 using 5- and 4-point Likert scale self-administered questionnaires.'}, {'measure': 'Intimate Partner Violence (IPV)', 'timeFrame': 'Month 12', 'description': 'Participant-reported history, frequency, and severity of IPV (physical and psychological) at study Month 12 using polar (Yes/No), 5- and 4-point Likert scale self-administered questionnaires.'}, {'measure': 'Healthy relationship attitudes, beliefs, and behaviors', 'timeFrame': 'Month 6', 'description': 'Participant-reported attitudes, beliefs, and behaviors about healthy relationships (conflict management skills and emotion regulation) for themselves, their families, or in general at study Month 6 using 5- and 4-point Likert scale self-administered questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Young Adult Parents', 'Adolescent Pregnancy', 'Adolescent Parents', 'Healthy Relationships'], 'conditions': ['Gender-based Violence', 'Intimate Partner Violence']}, 'descriptionModule': {'briefSummary': 'The goal of this trial is to learn how the Safe Dates for Young Parents (SDYP) intervention affects the sexual and reproductive health behaviors, and quality of, and attitudes surrounding intimate partner relationships in adolescents and young adults (AYA) assigned female sex at birth who are pregnant or parenting.\n\nThe main questions it aims to answer are:\n\n* Will the SDYP intervention have any effect on the sexual and reproductive health behaviors during the study period?\n* Will the SDYP intervention have any effect on the prevention or reduction of intimate partner violence (IPV)?\n* Will the SDYP intervention have any effect on the attitudes and beliefs about healthy relationships?\n\nResearchers will compare the behaviors, attitudes, and beliefs about sexual and reproductive health and relationships of participants assigned to the SDYP intervention group to participants assigned to the control (non-SDYP intervention) group to see if there is any difference or changes in those behaviors, attitudes, and beliefs before-and-after or without the SDYP intervention.\n\nParticipants in the SDYP intervention will attend ten (10) 50-minute group sessions that will involve interactive discussions, thinking through life-like scenarios, games, role-plays, brainstorming, and a poster contest and theatrical play.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdolescent and Young Adult (AYA) \\[EYP study participants\\]\n\n* Aged 14-21 years (inclusive) at Screening.\n* Assigned female sex at birth.\n* Currently pregnant or parenting their child who lives with them at least part-time.\n* Able to speak and read English or Spanish.\n* Able and willing to provide verbal informed consent for enrollment in the EYP study.\n* Able and willing to provide adequate contact/locator information.\n* Able and willing to complete protocol requirements, including completion of three study interviews over one year.\n\nStudy Facilitators (process evaluation participants)\n\n* Aged 18 years or older.\n* Trained and served as a facilitator of the SDYP intervention.\n* Able to speak and read English.\n* Able and willing to provide verbal informed consent.\n\nExclusion Criteria:\n\n* Per participant report at Screening or Enrollment, intends to travel away from their geographic area of residence for a time period that would interfere with study participation, including with intervention participation should the participant be randomized to the SDYP intervention.\n* Has any other condition that, in the opinion of the Principal Investigator (PI) or their designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.'}, 'identificationModule': {'nctId': 'NCT06576193', 'acronym': 'EYP', 'briefTitle': 'Empowering Young Parents: Building Healthy Relationships Study', 'organization': {'class': 'OTHER', 'fullName': 'RTI International'}, 'officialTitle': 'Empowering Young Parents: Building Health Relationships Study Evaluation of the Safe Dates for Young Parents Intervention', 'orgStudyIdInfo': {'id': 'TP2AH000082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safe Dates for Young Parents (SDYP)', 'description': 'Participants will receive and complete SDYP intervention activities focused on healthy relationships and intimate partner violence (IPV) prevention plus standard services offered at the study site.', 'interventionNames': ['Behavioral: Safe Dates for Young Parents (SDYP)']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Services Only', 'description': 'Participants will only receive standard-of-care programming that typically includes services such as one-on-one strength-based case management and comprehensive sex education. The standard services will not address IPV or healthy relationships content that composes the SDYP intervention. Referrals to additional services will be offered to all participants, as needed.'}], 'interventions': [{'name': 'Safe Dates for Young Parents (SDYP)', 'type': 'BEHAVIORAL', 'description': 'SDYP is a healthy relationship and intimate partner violence (IPV) prevention program, adapted from "Safe Dates (Foshee et al., 1998; Foshee et al., 1996)" designed for teens, that focuses on pregnant or parenting females. The program consists of ten group-based sessions (50 minutes each) led by a trained facilitator which include interactive discussions, analysis of scenarios, games, role-plays, brainstorming, and a poster contest and theatrical play.', 'armGroupLabels': ['Safe Dates for Young Parents (SDYP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19934', 'city': 'Camden', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maleka Pettyjohn', 'role': 'CONTACT', 'email': 'mpettyjohn@dapi.org', 'phone': '302-697-0356'}], 'facility': 'Delaware Adolescent Program, Inc. (DAPI) - Kent County', 'geoPoint': {'lat': 39.11345, 'lon': -75.54187}}, {'zip': '19947', 'city': 'Georgetown', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Wright', 'role': 'CONTACT', 'email': 'kwright@dapi.org', 'phone': '302-722-2261'}], 'facility': 'Delaware Adolescent Program, Inc. (DAPI) - Sussex County', 'geoPoint': {'lat': 38.69011, 'lon': -75.38547}}, {'zip': '20020', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yael Smiley', 'role': 'CONTACT', 'email': 'YTSmiley@childrensnational.org', 'phone': '202-476-2123'}], 'facility': "Healthy Generations Program at Children's National Hospital", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '31701', 'city': 'Albany', 'state': 'Georgia', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'GCAPP and Communities In Schools of Albany/Dougherty', 'geoPoint': {'lat': 31.57851, 'lon': -84.15574}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'GCAPP and Covenant House Georgia', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '49022', 'city': 'Benton Harbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Miranda Dopp', 'role': 'CONTACT', 'email': 'mdopp@bchdmi.org', 'phone': '269-927-5635'}], 'facility': 'Berrien County Health Department', 'geoPoint': {'lat': 42.11671, 'lon': -86.45419}}, {'zip': '48813', 'city': 'Charlotte', 'state': 'Michigan', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Eaton Regional Education Service Agency (RESA)', 'geoPoint': {'lat': 42.56365, 'lon': -84.83582}}, {'zip': '48214', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debra Meadows', 'role': 'CONTACT', 'email': 'DMeadows@pathwaysdetroit.com', 'phone': '313-209-3804'}], 'facility': 'Pathways Academy', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48601', 'city': 'Saginaw', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rosa Davis', 'role': 'CONTACT', 'email': 'rdavis@sisd.cc', 'phone': '989-399-7453'}], 'facility': 'Saginaw Intermediate School District', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '27253', 'city': 'Graham', 'state': 'North Carolina', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'The Exchange Club', 'geoPoint': {'lat': 36.06903, 'lon': -79.40058}}, {'zip': '28792', 'city': 'Hendersonville', 'state': 'North Carolina', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Children & Family Resource Center', 'geoPoint': {'lat': 35.31873, 'lon': -82.46095}}, {'zip': '27330', 'city': 'Sanford', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cristal Avalos', 'role': 'CONTACT', 'email': 'empoweryounc@gmail.com', 'phone': '919-774-9496'}], 'facility': 'Empowering Connections, Partnership for Children & Families', 'geoPoint': {'lat': 35.47988, 'lon': -79.1803}}], 'centralContacts': [{'name': 'Marni Kan, PhD', 'role': 'CONTACT', 'email': 'mkan@rti.org', 'phone': '919-485-2756'}], 'overallOfficials': [{'name': 'Marni Kan, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RTI International'}, {'name': 'Alexandra Minnis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RTI International'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RTI International', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}