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Substance Misuse and Family Violence Treatment Fathers

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Yale University

Status and phase

Enrolling
Phase 2

Conditions

Violence, Domestic
Child Abuse
Substance Misuse

Treatments

Behavioral: Fathers for Change (F4C)
Behavioral: Individual Drug Counseling (IDC)

Study type

Interventional

Funder types

Other
Other U.S. Federal agency
NIH

Identifiers

NCT06650267
2000038147
1R01DA059914-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

280 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

280 participants in 2 patient groups

Fathers for Change
Experimental group
Treatment:
Behavioral: Fathers for Change (F4C)
Individual Drug Counseling
Active Comparator group
Treatment:
Behavioral: Individual Drug Counseling (IDC)

Trial contacts and locations

2

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Central trial contact

Carla S Stover, Ph.D.

Data sourced from clinicaltrials.gov

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