- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07140276
- Original Trial
An Integrated Substance Abuse-Domestic Violence (SADV) Treatment Outcome Study
August 18, 2025 updated by: Yale University
An Integrated Substance Abuse-Domestic Violence (SADV) Treatment Outcome Study: A Stage 1 Trial for SADV
Investigators will conduct a randomized trial comparing individual SADV to a manualized comparison condition that focuses on substance use only.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The randomized trial will be informed by previous work developing and refining the interventions and training materials used in the randomized trial.
The focus of this registration is the randomized trial.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Yale New Haven Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Individual SADV Therapy
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.
|
12 weeks individual psychotherapy
|
|
Experimental: Manualized comparison condition
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.
|
12 weeks using the manual provided
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Days of substance use
Time Frame: Weekly up to 12 weeks
|
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
Time Frame: Weekly up to 12 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Caroline Easton, PhD, University of Rochester
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2007
Primary Completion (Actual)
June 30, 2010
Study Completion (Actual)
June 30, 2010
Study Registration Dates
First Submitted
August 18, 2025
First Submitted That Met QC Criteria
August 18, 2025
First Posted (Actual)
August 24, 2025
Study Record Updates
Last Update Posted (Actual)
August 24, 2025
Last Update Submitted That Met QC Criteria
August 18, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10492 (Other Identifier: CTEP)
- RDA018284A (Other Grant/Funding Number: NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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