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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01621334
Other study ID # 37863-C
Secondary ID R01DA017873
Status Completed
Phase Phase 1
First received August 16, 2011
Last updated June 13, 2012
Start date September 2009
Est. completion date May 2012

Study information

Verified date June 2012
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This research is a stage 1b developmental trial evaluating an intervention called "The Men's Domestic Abuse Check-Up" with adult men abusing their intimate partners and also struggling with alcohol or drug use.


Description:

One hundred and forty adult men concerned about their substance use and behaviors toward intimate partners, recruited in Washington State, will be enrolled in the trial. Participants are recruited through print and radio ads. Following a baseline assessment, participants are then randomly assigned to receive one of two interventions:

- The experimental intervention is a two-session motivational enhancement treatment. A personalized feedback report, containing information from the participant's assessment as well as normative comparison data, is reviewed, with the counselor employing motivational interviewing strategies intended to impact study outcomes.

- The comparison condition involves an educational brochure focusing on the legal, health and behavioral effects of intimate partner violence, substance abuse, and HIV risky behaviors.

Following the two interventions, participants are reassessed at 1 week, 1 month, and 4 months following either intervention.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age (18 years and older)

- gender (male)

- self-reported abusive behaviors

- concerned about alcohol or drug use

Exclusion Criteria:

- not fluent in English

- they have a thought disorder that precludes full participation

- they refuse to accept randomization to condition

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational Enhancement Therapy
Two personal feedback sessions with counselor using motivational interviewing strategies.
Educational information
Educational brochure about legal, health and behavioral effects of intimate partner violence, substance abuse, and HIV risky behaviors

Locations

Country Name City State
United States Innovative Programs Research Group, School of Social Work, University of Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary treatment seeking 4 months No
Secondary self-report of intimate partner violence and substance use 4 months No
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