Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-05 @ 6:02 PM
Study NCT ID:
NCT06160050
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2023-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRESERVE & CONNECT: Impact Study of the BPC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The Preserve and Connect Project will be a two arm (BPC+ TAU vs TAU) parallel randomized clinical trial to determine the efficacy of the BPC and establish the evidence base to allow the BPC to be listed on the Title IV-E Clearing House. Participants will be recruited from individuals seeking treatment from our community partners.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2023-06-23', 'studyFirstSubmitQcDate': '2023-11-28', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child Safety', 'timeFrame': 'up to 6 months', 'description': 'substantiated reports of child maltreatment as per administrative records'}, {'measure': 'Child Permanency', 'timeFrame': 'up to 6 months', 'description': 'out of family placements and placement disruptions as per administrative records. Total amount of each type of placement.'}, {'measure': 'Child Well-being', 'timeFrame': '10 weeks', 'description': 'behavioral and emotional functioning of their children (Strength and Difficulties Questionnaire).'}, {'measure': 'Parenting Self-Efficacy Scale', 'timeFrame': '10 weeks', 'description': 'Scores range from 0-160. Higher scores indicate more self efficacy'}], 'secondaryOutcomes': [{'measure': 'Parental Stress Index', 'timeFrame': '10 weeks', 'description': 'Parent Stress Index Self-Report Measure'}, {'measure': 'Trauma-Informed Knowledge and Parenting Skills Survey', 'timeFrame': '10 weeks', 'description': 'understanding of the influence of trauma on their parenting behaviors and wellness'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Child Maltreatment', 'Trauma']}, 'descriptionModule': {'briefSummary': 'The PRESERVE \\& CONNECT project is a multi-site randomized control trial of the Breakthrough Parenting Curriculum: Navigating Trauma Across Generations (BPC) in rural and racially and ethnically diverse communities in Vermont and Connecticut.', 'detailedDescription': 'The proposed study will determine the efficacy of the BPC at improving the lives of families with a significant history of trauma and establish the evidence base to allow the BPC to be listed on the Title IV-E Clearing House. The specific research questions that will be answered as are as follows:\n\nQuestion 1: Does the BPC improve Child Safety? Hypothesis 1a: Parents who complete the BPC will have fewer substantiated of child maltreatment as per administrative records.\n\nHypothesis 1b: Parents who complete the BPC will report less psychologically aggressive and abusive parenting behaviors (Parenting Scale).\n\nQuestion 2: Does the BPC improve Child Permanency? Hypothesis 2a: Parents who complete the BPC will have fewer out of family placements and placement disruptions as per administrative records.\n\nHypothesis 2b: Parents who complete the BPC will have stability or permanency with their family of origin as per administrative records.\n\nQuestion 3: Does the BPC improve Child Well-Being? Hypothesis 3: Parents who complete the BPC will report improved behavioral and emotional functioning of their children (Strength and Difficulties Questionnaire).\n\nQuestion 4: Does the BPC improve Adult Well-Being? Hypothesis 4a: Parents who complete the BPC will report improved use of parenting practices to improve the functional relationship with their children (Parenting Self-Efficacy Scale; Parent Stress Index, Parent-Child Relationship Scales).\n\nHypothesis 4b: Parents who complete the BPC will report improved understanding of the influence of trauma on their parenting behaviors and wellness (Trauma-Informed Knowledge and Parenting Skills Survey).\n\nQuestion 5: Are the improvements of the BPC associated with demographic factors? Exploratory Analysis 5a: Examine the association between measures of child safety, child well-being, child permanency, and adult well-being and measures of acculturation.\n\nExploratory Analysis 5a: Examine the association between measures of child safety, child well-being, child permanency, and adult well-being and measures of acculturation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Parents involved in, or at risk of involvement in, the child welfare system.\n\nExclusion Criteria:\n\n* active psychosis without medication stabilization\n* ongoing major depressive episodes\n* active suicidal ideation\n* active homicidal ideation'}, 'identificationModule': {'nctId': 'NCT06160050', 'acronym': '(BPC)', 'briefTitle': 'PRESERVE & CONNECT: Impact Study of the BPC', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont'}, 'officialTitle': 'Randomized Control Trial of the Breakthrough Parenting Curriculum: Transforming Trauma Across Generations', 'orgStudyIdInfo': {'id': '2648'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BPC', 'interventionNames': ['Behavioral: Breakthrough Parenting Curriculum: Transforming trauma across generations']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual'}], 'interventions': [{'name': 'Breakthrough Parenting Curriculum: Transforming trauma across generations', 'type': 'BEHAVIORAL', 'description': 'The BPC (Breakthrough Parent Curriculum): Navigating Trauma Across Generations is a 10 module course adapted from the NCTSN training called Caring for Children Who Have Experienced Trauma: A Workshop for Resource Parents (RPC). The BPC is specifically designed for parents who have been involved with (or are at risk for being involved with)the child welfare system. The course provides information about the impact of trauma on the development, attachment, emotions and behaviors of children while holding space for parents to learn together about concrete strategies for managing daily and ongoing challenges and enhancing their relationships with their children. All while acknowledging the challenges of parenting a child who has experienced trauma, while having experienced your own trauma.', 'armGroupLabels': ['BPC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06103', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jon Philips', 'role': 'CONTACT', 'email': 'jon.phillips@uconn.edu', 'phone': '(959) 200-3600'}], 'facility': 'University of Connecticut', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Strolin (Goltzman)', 'role': 'CONTACT', 'email': 'Jessica.Strolin@uvm.edu', 'phone': '8028603173'}], 'facility': 'University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Connecticut', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jessica Strolin-Goltzman', 'investigatorAffiliation': 'University of Vermont'}}}}