RecruitingPhase 2

Substance Misuse and Family Violence Treatment Fathers

United States280 participantsStarted 2025-02-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Substance Misuse

Timeframe: Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45

Family Violence (FV)

Timeframe: Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45

Trial details

NCT IDNCT06650267

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-31

Contact for this trial

Carla S Stover, Ph.D.

2037853486 carla.stover@yale.edu

View on ClinicalTrials.gov More Substance Misuse trials