Substance Misuse and Family Violence Treatment Fathers

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06650267
Phase
PHASE2
Status
Recruiting
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Conditions

  • Child Abuse
  • Substance Misuse
  • Violence, Domestic

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 17, 2025
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fathers for Change
  • Active Comparator: Individual Drug Counseling

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale University Child Study CenterNew HavenConnecticut06520
Quyen Do, PhD
[email protected]
2037847707
APT FoundationWest HavenConnecticut06516
Diana Potwardowski

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