Clinical trial NCT06650267: Substance Misuse and Family Violence Treatment Fathers
Official title: Substance Misuse and Family Violence Treatment for Fathers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Substance Misuse
Violence, Domestic
Child Abuse
Keywords: substance misuse
intimate partner violence
domestic violence
treatment
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: APT Foundation, Inc.
name: VA Connecticut Healthcare System
name: National Institute on Drug Abuse (NIDA)
First posted: 2024-10-21
Enrollment: 280
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Substance Misuse
timeFrame: Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45
measure: Family Violence (FV)
timeFrame: Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45
Secondary outcomes:
measure: Emotion Dysregulation
timeFrame: Baseline (week 0), Post-Treatment at week 19, week 32 and week 45
measure: Articulated Thoughts in Simulated Situations (ATSS)
timeFrame: Baseline (week 0) and Post-Treatment (week 18)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University Child Study Center
state: Connecticut
city: West Haven
country: United States
facility: APT Foundation
state: Connecticut
Study officials:
affiliation: Yale University
name: Carla S Stover, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: