Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-27 @ 8:13 AM
Study NCT ID:
NCT04980794
Status:
RECRUITING
Last Update Posted:
2024-11-15
First Post:
2021-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Happy Families Project: Testing the Effectiveness of a Conflict Resolution Program for Families
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants are blind to condition assignments during their involvement in the program.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomly assigned to one of two conditions.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Strengths and Difficulties Questionnaire (SDQ)', 'timeFrame': '1 year', 'description': 'Youth Adjustment'}, {'measure': 'Center for Epidemiological Studies Depression Scale (CESD)', 'timeFrame': '1 year', 'description': 'Youth Adjustment'}, {'measure': "Revised Children's Manifest Anxiety Scale (RCMAS)", 'timeFrame': '1 year', 'description': 'Youth Adjustment'}, {'measure': 'Child Behavior Checklist (CBCL)', 'timeFrame': '1 year', 'description': 'Youth Adjustment'}, {'measure': "O'Leary Porter Scale (OPS)", 'timeFrame': '1 year', 'description': 'Interadult Conflict'}, {'measure': 'Family Interactions Coding Scale', 'timeFrame': '1 year', 'description': 'Observational measures of interadult and family conflict'}, {'measure': 'Security in the Marital System Questionnaire (SIMS-PR)', 'timeFrame': '1 year', 'description': 'Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness'}, {'measure': 'Security in the Subsystem (SIS)', 'timeFrame': '1 year', 'description': 'Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness'}, {'measure': 'Security in the Family System (SIFS)', 'timeFrame': '1 year', 'description': 'Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness'}, {'measure': 'Organizational Characteristics Measure (purpose created measure of organizational characteristics)', 'timeFrame': '4 years', 'description': 'Testing organizational factors associated with program effectiveness'}, {'measure': "Leadership Perspective Measure (purpose created measure of organizational leaderships' perspective on program, implementation and sustainability)", 'timeFrame': '4 years', 'description': 'Testing organizational factors associated with program effectiveness'}, {'measure': "Facilitator Perspective Measure (purpose created measure of community facilitators' perspective on program implementation and training)", 'timeFrame': '4 years', 'description': 'Testing organizational factors associated with program effectiveness'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health', 'Conflict']}, 'descriptionModule': {'briefSummary': 'This study is designed to test the effectiveness of a psychoeducation-based program to address communication and conflict resolution in families, thereby supporting mental health in children and their caregivers.', 'detailedDescription': 'The goal of the study is to evaluate the effectiveness of a program to improve mental health in families by reducing stress and supporting effective communication and conflict resolution.\n\nFamilies will be randomly assigned to one of two conditions: in the self-study condition, families will receive information to review on their own, paired with regular (weekly) contact from a family coach; in the second condition, families will receive information to review on their own, regular contact from a coach, and will participate in video sessions with a family coach who will provide feedback on their interactions and coaching on their use of a communication technique. Data collection, management and analysis will be conducted by researchers at the University of Notre Dame, but the intervention will occur through community organizations in three cities in Indiana, allowing for tests of the effectiveness of the program when it is implemented in community settings. Families will participate in a pre-test assessment, a four-week intervention, a post-test assessment, and a one-year follow up assessment. Also evaluated will be organizational factors and factors that impact ultimate implementation and scalability of the program in community settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Two parents or primary caregivers\n* Child between 4 and 17 years old\n* English literate\n* Able/willing to participate through the 12-month follow up assessment.\n\nExclusion Criteria:\n\n* Families who cannot communicate in English\n* Single parent families'}, 'identificationModule': {'nctId': 'NCT04980794', 'briefTitle': 'The Happy Families Project: Testing the Effectiveness of a Conflict Resolution Program for Families', 'organization': {'class': 'OTHER', 'fullName': 'University of Notre Dame'}, 'officialTitle': 'Effectiveness of an Empirically Supported Family Intervention: Mental Health Outcomes, Mechanisms of Effect, and Organizational Factors', 'orgStudyIdInfo': {'id': '20-0852'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parent-Child Intervention', 'description': 'This is a four-dose intervention that includes psychoeducational modules and communication coaching administered through community organizations over the course of four weeks. Both participating adults and the participating child receive materials to review each week, paired with weekly contact from a family coach.', 'interventionNames': ['Behavioral: Parent-child intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self-study intervention', 'description': 'This is a four-dose intervention that include written self-study materials to review, paired with weekly contact with a family coach. Both participating adults receive self-study materials; the participating child does not receive separate materials.', 'interventionNames': ['Behavioral: Self-study Intervention']}], 'interventions': [{'name': 'Parent-child intervention', 'type': 'BEHAVIORAL', 'description': 'Families (two adult caregivers, child between 4 and 17) receive four interactive, asynchronous psychoeducation modules to review on their own paired with weekly contact with a communication coach and two live sessions with a communication coach to discuss psychoeducation, receive feedback on their interactions, and practice a communication technique.', 'armGroupLabels': ['Parent-Child Intervention']}, {'name': 'Self-study Intervention', 'type': 'BEHAVIORAL', 'description': 'Families (two adult caregivers) receive information in a newsletter format to review on their own, paired with weekly contact from a communication coach to answer questions and direct their attention toward specific topics in the newsletter.', 'armGroupLabels': ['Self-study intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46814', 'city': 'Fort Wayne', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katie Bergman, PhD', 'role': 'CONTACT', 'email': 'kbergman@nd.edu', 'phone': '574-631-0956'}], 'facility': 'Fort Wayne Center for Children and Families', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katie Bergman, PhD', 'role': 'CONTACT', 'email': 'kbergman@nd.edu', 'phone': '574-631-0956'}, {'name': 'John G Borkowski, PhD', 'role': 'CONTACT', 'email': 'jborkows@nd.edu'}], 'facility': 'Indianapolis Virtual Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46556', 'city': 'Notre Dame', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katie Bergman, PhD', 'role': 'CONTACT', 'email': 'kbergman@nd.edu', 'phone': '574-631-0956'}, {'name': 'E. Mark Cummings, PhD', 'role': 'CONTACT', 'email': 'ecumming@nd.edu', 'phone': '574-631-0956'}], 'facility': 'University of Notre Dame', 'geoPoint': {'lat': 41.70019, 'lon': -86.23793}}], 'centralContacts': [{'name': 'Katie N Bergman, PhD', 'role': 'CONTACT', 'email': 'kbergman@nd.edu', 'phone': '574-631-0956'}, {'name': 'E. Mark Cummings, PhD', 'role': 'CONTACT', 'email': 'ecumming@nd.edu', 'phone': '574-631-4947'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Notre Dame', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}