Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-01 @ 10:14 AM
Study NCT ID:
NCT05562557
Status:
RECRUITING
Last Update Posted:
2025-01-30
First Post:
2022-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Regional Partnership to Improve Outcomes Through Fatherhood Engagement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019090', 'term': 'Case Management'}], 'ancestors': [{'id': 'D010347', 'term': 'Patient Care Planning'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2022-09-29', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child well-being, as measured by: Child Behavior Checklist', 'timeFrame': 'Baseline', 'description': 'This is a standardized self-report measure widely used in the measure of child behavior and child well-being. A separate form is used for children aged 1.5-5, and 6-18. The questionnaire is completed by the caregiver using a series of Likert scales (0=absent, 1=sometimes, 2=often occurs). There are 113 questions, measuring a series of internalizing (e.g., anxious/ depressed, depressed, somatic complaints) and externalizing (e.g., attention problems, rule-breaking behavior, aggression) symptoms over the prior 6-months. Raw scores are standardized into t-scores, with elevated scores reflecting greater symptomatology when compared to a gender and aged normed population.'}, {'measure': 'Child well-being, as measured by: Child Behavior Checklist', 'timeFrame': 'Follow Up (6-months after Baseline)', 'description': 'This is a standardized self-report measure widely used in the measure of child behavior and child well-being. A separate form is used for children aged 1.5-5, and 6-18. The questionnaire is completed by the caregiver using a series of Likert scales (0=absent, 1=sometimes, 2=often occurs). There are 113 questions, measuring a series of internalizing (e.g., anxious/ depressed, depressed, somatic complaints) and externalizing (e.g., attention problems, rule-breaking behavior, aggression) symptoms over the prior 6-months. Raw scores are standardized into t-scores, with elevated scores reflecting greater symptomatology when compared to a gender and aged normed population.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Substance Use', 'Child Abuse', 'Child Neglect', 'Fathers', 'Father-Child Relations']}, 'descriptionModule': {'briefSummary': 'Montefiore will engage fathers in families at risk of substance misuse in the Bronx and neighboring communities. Families will be referred from Bronx and neighboring community-based child welfare systems, substance use disorder (SUD) treatment providers, and medical providers if identified at risk of substance use concerns and will be randomly assigned to receive services as usual as part of the comparison group, or to receive enhanced services as part of the program group.\n\nEnhanced services include: (1) Motivational Enhancement; (2) referral to Healthy, Empowered, Resilient, and Open (HERO) Dads fatherhood engagement program; (3) Contingency Management; and (4) Case Management.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'As this project is about fatherhood, only those who identify as fathers will be included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (i) is a custodial or non-custodial father,\n* (ii) who has at least one child under the age of 18,\n* (iii) someone in the family is identified as at-risk for substance use\n\nExclusion Criteria:\n\n* The placement of all children in the family in foster care'}, 'identificationModule': {'nctId': 'NCT05562557', 'briefTitle': 'A Regional Partnership to Improve Outcomes Through Fatherhood Engagement', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'A Regional Partnership for New York City to Improve Well-Being and Child Welfare Outcomes Among Families at Risk of Substance Misuse Through Fatherhood Engagement', 'orgStudyIdInfo': {'id': '2022-14401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Services as Usual', 'description': 'Randomly assigned to receive services as usual'}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced Fatherhood Services through Regional Partnership Grant Round 7 (RPG7)', 'description': 'Randomly assigned to receive enhanced RPG7 services (motivational enhancement, fatherhood engagement services, contingency management, case management)', 'interventionNames': ['Behavioral: Motivational Enhancement', 'Behavioral: HERO Dads Fatherhood Program', 'Behavioral: Contingency Management', 'Behavioral: Case Management']}], 'interventions': [{'name': 'Motivational Enhancement', 'type': 'BEHAVIORAL', 'description': 'To encourage intrinsic motivation to engage in fatherhood activities', 'armGroupLabels': ['Enhanced Fatherhood Services through Regional Partnership Grant Round 7 (RPG7)']}, {'name': 'HERO Dads Fatherhood Program', 'type': 'BEHAVIORAL', 'description': 'Fatherhood engagement curriculum to increase awareness, knowledge, and skills for parenting and co-parenting', 'armGroupLabels': ['Enhanced Fatherhood Services through Regional Partnership Grant Round 7 (RPG7)']}, {'name': 'Contingency Management', 'type': 'BEHAVIORAL', 'description': 'To reinforce healthy behaviors, including attendance at services', 'armGroupLabels': ['Enhanced Fatherhood Services through Regional Partnership Grant Round 7 (RPG7)']}, {'name': 'Case Management', 'type': 'BEHAVIORAL', 'description': 'Referrals to treatment, social services, and employment services', 'armGroupLabels': ['Enhanced Fatherhood Services through Regional Partnership Grant Round 7 (RPG7)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alessandra de Marchena, LCSW', 'role': 'CONTACT', 'email': 'allongo@montefiore.org', 'phone': '718-401-5060'}, {'name': 'Anita Jose, PhD', 'role': 'CONTACT', 'email': 'ajose@montefiore.org', 'phone': '7184015060'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'Anita Jose, PhD', 'role': 'CONTACT', 'email': 'ajose@montefiore.org', 'phone': '718-401-5060'}, {'name': 'Alessandra de Marchena, LCSW', 'role': 'CONTACT', 'email': 'allongo@montefiore.org', 'phone': '718-401-5060'}], 'overallOfficials': [{'name': 'Scott Wetzler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No current plan. May be possible to provide individual data (de-identified) for secondary data analysis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}