NCT06650267 Substance Misuse and Family Violence Treatment Fathers
| NCT ID | NCT06650267 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Yale University |
| Condition | Substance Misuse |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2025-02-17 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 280 participants in total. It began in 2025-02-17 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * meet DSM-5 criteria for an SU disorder at the time of assessment at APT or VACHS; * report FV within the last 18 months prior to screening (based on self, court, police or child protection reports); * 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; * are able to complete assessments in English; and * 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. Exclusion Criteria: * an active full/no contact protective order pertaining to their child; * physiological addiction to a substance that requires detoxification (such individuals may be re-evaluated following detox); * cognitive impairment (a mini mental state score \<25); * current untreated psychotic/bipolar disorder; * currently suicidal or homicidal based on Brief Symptom Inventory Screening and follow-up on positive responses; or * are currently receiving weekly individual therapy for Substance misuse or family violence
Contact & Investigator
Carla S Stover, Ph.D.
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06650267 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Substance Misuse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06650267 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06650267 currently recruiting?
Yes, NCT06650267 is actively recruiting participants. Contact the research team at carla.stover@yale.edu for enrollment information.
Where is the NCT06650267 trial being conducted?
This trial is being conducted at New Haven, United States, West Haven, United States.
Who is sponsoring the NCT06650267 clinical trial?
NCT06650267 is sponsored by Yale University. The principal investigator is Carla S Stover, Ph.D. at Yale University. The trial plans to enroll 280 participants.