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NCT Number: NCT06650267

Substance Misuse and Family Violence Treatment Fathers

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.

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Key information

Conditions

Substance Misuse Child Abuse Violence, Domestic

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Yale University Child Study Center, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fathers for Change (F4C)

Behavioral

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)

Behavioral

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 outcomes

  1. Substance Misuse

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

    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.

  2. 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

    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

Secondary outcomes

  1. Emotion Dysregulation

    Time frame: Baseline (week 0), Post-Treatment at week 19, week 32 and week 45

    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.

  2. Articulated Thoughts in Simulated Situations (ATSS)

    Time frame: Baseline (week 0) and Post-Treatment (week 18)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carla S Stover, Ph.D.

CONTACT

[email protected]

2037853486

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • APT Foundation, Inc.
  • National Institute on Drug Abuse (NIDA)
  • VA Connecticut Healthcare System

Registry information

Official study title

Substance Misuse and Family Violence Treatment for Fathers

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Oct 21, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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