Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-31 @ 6:37 AM
Study NCT ID:
NCT05587335
Status:
UNKNOWN
Last Update Posted:
2022-10-20
First Post:
2022-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project Harmony 2.0: Relationship Education for Couples
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', 'interventionModelDescription': 'In person and online arms'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2022-09-22', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Revised Dyadic Adjustment Scale', 'timeFrame': '6 months', 'description': 'The Revised Dyadic Adjustment Scale (RDAS) is a self report questionnaire that assesses seven dimensions of couple relationships. The RDAS includes only 14 items, ranging from 0 to 69 with higher scores indicating greater relationship satisfaction and lower scores indicating greater relationship distress. The cut-off score for the RDAS is 48 such that scores of 48 and above indicate non-distress and scores of 47 and below indicate marital/relationship distress.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Marital Relationship']}, 'descriptionModule': {'briefSummary': 'Project Harmony directly addresses prioritized areas identified by Administration of Children and Families, emphasizing healthy marriage promotion activities and career advancement opportunities for adults. Included in service provisions are elements of: \\[a\\] marriage and relationship education/skills, \\[b\\] marriage enhancement, \\[c\\] divorce reduction and \\[d\\] job and career advancement. The targeted service population for Project Harmony includes married/committed couples in the greater Orlando metro area.', 'detailedDescription': 'The primary program consists of 12 hours of relationship education. The investigators seek to conduct an impact evaluation utilizing a randomized control trial (RCT) to compare outcomes of couples enrolled in either face to face relationship education or web-based relationship education to assess the impact of program structure on outcomes. By offering both face to face and online versions of evidenced based curricula, the investigators are directly addressing requests from ongoing needs assessments of our targeted population. The project is designed for couples 18 years and older; all participants in the face-to-face group will receive the Prevention and Relationship Education Program (PREP) 8.0 + Career Pathways Program (CPP) curricula whereas couples in the online group will receive the OurRelationship Intervention + CPP curricula.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be 18 years older and be in a committed relationship, must attend with partners\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05587335', 'briefTitle': 'Project Harmony 2.0: Relationship Education for Couples', 'organization': {'class': 'OTHER', 'fullName': 'University of Central Florida'}, 'officialTitle': 'Project Harmony 2.0: A Relationship Education Intervention for Couples', 'orgStudyIdInfo': {'id': 'UCFloirda'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'In person', 'description': 'Couples will be assigned into in person relationship intervention.', 'interventionNames': ['Behavioral: PREP']}, {'type': 'EXPERIMENTAL', 'label': 'Online', 'description': 'Couples will be assigned into online relationship intervention.', 'interventionNames': ['Behavioral: OurRelationship']}], 'interventions': [{'name': 'PREP', 'type': 'BEHAVIORAL', 'description': 'Relationship intervention to improve communication and conflict resolution for couples', 'armGroupLabels': ['In person']}, {'name': 'OurRelationship', 'type': 'BEHAVIORAL', 'description': 'Relationship intervention to improve communication and conflict resolution for couples', 'armGroupLabels': ['Online']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32816', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sejal Barden, PhD', 'role': 'CONTACT', 'email': 'sejal.barden@ucf.edu', 'phone': '407-823-1748'}], 'facility': 'University of Central Florida', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'Sejal Barden', 'role': 'CONTACT', 'email': 'sejal.barden@ucf.edu', 'phone': '4078231748'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Central Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}