Substance Misuse and Family Violence Treatment Fathers

Phase 2

Recruiting

• Conditions: Substance Misuse; Violence, Domestic; Child Abuse

• Registration Number: NCT06650267
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2024-10-17
• Study First Posted: 2024-10-21
• Study Start: 2025-02-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2029-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 280

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Substance Misuse	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.
Family Violence (FV)	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 Outcome Measures

Name	Time	Method
Emotion Dysregulation	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.
Articulated Thoughts in Simulated Situations (ATSS)	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.

Trial Locations

Locations (2)

Yale University Child Study Center; 🇺🇸 New Haven, Connecticut, United States

APT Foundation; 🇺🇸 West Haven, Connecticut, United States