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Clinical Trials/NCT07140276
NCT07140276
Completed
Not Applicable

An Integrated Substance Abuse-Domestic Violence (SADV) Treatment Outcome Study: A Stage 1 Trial for SADV

Yale University1 site in 1 country63 target enrollmentStarted: July 3, 2007Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
63
Locations
1
Primary Endpoint
Mean Days of substance use

Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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