Recruiting
Phase 2

Substance Misuse

Sponsor:

Yale University

Code:

NCT06650267

Conditions

Substance Misuse

Violence, Domestic

Child Abuse

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fathers for Change (F4C)

Individual Drug Counseling (IDC)

Study Details

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.

Conditions

Substance Misuse

Violence, Domestic

Child Abuse

Study ID

NCT06650267

Start date

Feb 17, 2025

Status verified date

May, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fathers for Change

active comparator: Individual Drug Counseling

Interventions

Fathers for Change (F4C)

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.

Individual Drug Counseling (IDC)

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.

Primary outcome measure

  • Substance Misuse [ Time Frame: Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45 ]
  • Family Violence (FV) [ Time Frame: Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45 ]

Central Contacts and Locations

Central contacts

Carla S Stover, Ph.D.

2037853486carla.stover@yale.edu

Locations

Yale University Child Study Center

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Quyen Do, PhD

2037847707quyen.do@yale.edu

APT Foundation

Recruiting

West Haven, Connecticut, United States, 06516

More Information

Sponsor

Yale University

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • substance misuse
  • intimate partner violence
  • domestic violence
  • treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-05-22.