Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-02 @ 1:20 PM
Study NCT ID:
NCT06650267
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2024-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Substance Misuse and Family Violence Treatment Fathers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2024-10-16', 'studyFirstSubmitQcDate': '2024-10-17', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Substance Misuse', 'timeFrame': 'Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45', 'description': 'Self-reported days of substance misuse reported a positive breathalyzer/urine tox screen will be used to create a sum of the number of weeks with use during treatment and at each follow-up period.'}, {'measure': 'Family Violence (FV)', 'timeFrame': 'Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45', 'description': 'Any instance of FV either toward a partner or child identified by any report (self-report on the Timeline Followback weekly surveys, child protection or arrest record) will be counted to allow for the best estimate of FV across reports resulting in a sum count of the number of FV incidents during the 18 weeks of treatment and from post-treatment to each follow-up timepoint'}], 'secondaryOutcomes': [{'measure': 'Emotion Dysregulation', 'timeFrame': 'Baseline (week 0), Post-Treatment at week 19, week 32 and week 45', 'description': 'The Difficulties in Emotion Regulation Scale will be used to measure self-reported emotion regulation. Sum scores range from 18 to 90 with higher scores suggesting more impaired emotion regulation.'}, {'measure': 'Articulated Thoughts in Simulated Situations (ATSS)', 'timeFrame': 'Baseline (week 0) and Post-Treatment (week 18)', 'description': 'The participants responses to the ATSS will be coded for hostile responding and will serve as a non-self-report measure of emotion regulation. Scores range from 0 to 5 with 5 being greater hostile responding across scenarios.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['substance misuse', 'intimate partner violence', 'domestic violence', 'treatment'], 'conditions': ['Substance Misuse', 'Violence, Domestic', 'Child Abuse']}, 'descriptionModule': {'briefSummary': 'This study involves a randomized controlled trial of Fathers for Change (F4C) compared to Individual Drug Counseling (IDC) with a sample of 280 fathers enrolled in substance use (SU) treatment within community or veterans (VA) healthcare settings to (a) demonstrate F4C efficacy compared to IDC in reducing SU and family violence (FV) at end of treatment, 3- and 6-month post-treatment follow-up, and (b) document improved emotion regulation as the mechanism within F4C that results in reduced SU and FV.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* meet DSM-5 criteria for an SU disorder at the time of assessment at APT or VACHS;\n* report FV within the last 18 months prior to screening (based on self, court, police or child protection reports);\n* have at least one biological child aged 1 to 12 years with whom they live or have at least twice per month in person visits;\n* are able to complete assessments in English; and\n* agree to have their female coparents (mother of the youngest child) contacted for participation of their youngest child. If a participant has more than one child in the age range, the youngest will be the target of assessment and treatment.\n\nExclusion Criteria:\n\n* an active full/no contact protective order pertaining to their child;\n* physiological addiction to a substance that requires detoxification (such individuals may be re-evaluated following detox);\n* cognitive impairment (a mini mental state score \\<25);\n* current untreated psychotic/bipolar disorder;\n* currently suicidal or homicidal based on Brief Symptom Inventory Screening and follow-up on positive responses; or\n* are currently receiving weekly individual therapy for Substance misuse or family violence'}, 'identificationModule': {'nctId': 'NCT06650267', 'briefTitle': 'Substance Misuse and Family Violence Treatment Fathers', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Substance Misuse and Family Violence Treatment for Fathers', 'orgStudyIdInfo': {'id': '2000038147'}, 'secondaryIdInfos': [{'id': '1R01DA059914-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA059914-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fathers for Change', 'interventionNames': ['Behavioral: Fathers for Change (F4C)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Individual Drug Counseling', 'interventionNames': ['Behavioral: Individual Drug Counseling (IDC)']}], 'interventions': [{'name': 'Fathers for Change (F4C)', 'type': 'BEHAVIORAL', 'description': 'Defining features of F4C delivered over 18 sessions: 1) focus on the fathers model of fatherhood as a motivator for change, 2) focus on understanding and identifying feelings, teaching skills to identify and change emotional dysregulation that lead to both SU and FV, 3) co-parent communication skills to reduce stress and improve problem solving, 4) restorative parenting (see Table 1 and figure 1)127. F4C focuses on reflective understanding of emotional experiences, how that impacts thoughts and behaviors related to SU, FV, co-parenting/parenting each session. Through greater self-awareness, the father is better able to apply coping, communication and parenting skills introduced to reduce SU and FV.', 'armGroupLabels': ['Fathers for Change']}, {'name': 'Individual Drug Counseling (IDC)', 'type': 'BEHAVIORAL', 'description': 'IDC is an individual evidence-based SU treatment84 that incorporates two elements: endorsement of the disease model and the spiritual dimensions of recovery. These elements differentiate the approach from F4C. IDC is influenced by 12-step recovery philosophy and participation in 12-step groups like NA are encouraged. The model places focus on the individual in recovery without a focus on fatherhood or co-parenting. IDC will be offered in an 18-session format.', 'armGroupLabels': ['Individual Drug Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Quyen Do, PhD', 'role': 'CONTACT', 'email': 'quyen.do@yale.edu', 'phone': '203-784-7707'}], 'facility': 'Yale University Child Study Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diana Potwardowski', 'role': 'CONTACT'}], 'facility': 'APT Foundation', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'centralContacts': [{'name': 'Carla S Stover, Ph.D.', 'role': 'CONTACT', 'email': 'carla.stover@yale.edu', 'phone': '2037853486'}], 'overallOfficials': [{'name': 'Carla S Stover, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The research community will have access to data when the primary analyses have been completed and published.', 'ipdSharing': 'YES', 'description': 'Clinical/assessment data will be deposited into Harvard Dataverse at the conclusion of study data collection and publication of primary study specific aims.', 'accessCriteria': 'Researchers will request access to the data through a standard request and approval by the study PI and then release by the repository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'APT Foundation, Inc.', 'class': 'OTHER'}, {'name': 'VA Connecticut Healthcare System', 'class': 'FED'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}