Substance Misuse and Family Violence Treatment Fathers

NCT ID: NCT06650267

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-17

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Substance Misuse Violence, Domestic Child Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fathers for Change

Group Type EXPERIMENTAL

Fathers for Change (F4C)

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Individual Drug Counseling (IDC)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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APT Foundation, Inc.

OTHER

Sponsor Role collaborator

VA Connecticut Healthcare System

FED

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carla S Stover, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University Child Study Center

New Haven, Connecticut, United States

Site Status RECRUITING

APT Foundation

West Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Carla S Stover, Ph.D.

Role: CONTACT

2037853486

Facility Contacts

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Quyen Do, PhD

Role: primary

203-784-7707

Diana Potwardowski

Role: primary

Other Identifiers

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1R01DA059914-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000038147

Identifier Type: -

Identifier Source: org_study_id

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