NCT07140276

Brief Summary

Investigators will conduct a randomized trial comparing individual SADV to a manualized comparison condition that focuses on substance use only.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2010

Completed
15.1 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

August 18, 2025

Last Update Submit

August 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mean Days of substance use

    Days of substance use weekly from each participant endorsed as Y/N, by Self-report using time line follow back method, verified by alcohol concentration and urine toxicology

    Weekly up to 12 weeks

  • Mean Days of physical violence use

    Days of physical violence use weekly from each participant endorsed as Y/N, by Self-report using time line follow back method, verified by female collateral informant

    Weekly up to 12 weeks

Study Arms (2)

Individual SADV Therapy

EXPERIMENTAL

Men referred from court and probation for treatment of substance use and domestic violence related problems will receive 12 weeks of individual therapy that focuses on SADV.

Behavioral: Individual Therapy

Manualized comparison condition

EXPERIMENTAL

Men referred from court and probation for treatment of substance use and domestic violence related problems will receive 12 weeks of therapy using the manual provided that focuses on substance use only.

Behavioral: Individual Drug Counseling manual

Interventions

12 weeks individual psychotherapy

Individual SADV Therapy

12 weeks using the manual provided

Manualized comparison condition

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • referred by the courts or probation for treatment of substance use and domestic violence and who
  • meet current DSM-IV criteria for substance dependence (alcohol, cocaine and marijuana, and who have used that substance within the 30 days prior to the screening session)
  • report physical violence in an intimate relationship (pushing, slapping, kicking) within 30 days prior to screening
  • can read English at a 6th grade level.

You may not qualify if:

  • Currently in withdrawal from substances and in need of detoxification (such individuals may be re-evaluated following detoxification)
  • Have cognitive impairment (a mini mental state score \<25)
  • Have psychomotor epilepsy (e.g. impulsivity or rage related symptoms secondary to a seizure disorder, as this medical diagnosis is likely to be a confound in the proposed study)
  • Have major medical complications such as a head injury/trauma, or HIV dementia that may also be a confound in the study interventions
  • Currently receiving either substance abuse or IPV treatment elsewhere
  • Have a lifetime history of any psychotic or bipolar disorder
  • Currently suicidal or homicidal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Health System

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Caroline Easton, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Men referred by the courts or probation for treatment of substance use who have domestic violence related problems.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2025

First Posted

August 24, 2025

Study Start

July 3, 2007

Primary Completion

June 30, 2010

Study Completion

June 30, 2010

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations