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Adjunctive Motivational Alcohol Intervention to Prevent IPV (MET-SAH)

Primary Purpose

Alcohol Use and Intimate Partner Violence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Enhancement Therapy
Alcohol Education Control
Treatment as Usual
Strength at Home
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use and Intimate Partner Violence focused on measuring Intimate Partner Violence, Alcohol Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

All male Veteran participants must meet the following eligibility criteria:

  • participant is a Veteran
  • minimum age 18
  • participant is enrolled in the Strength at Home program following program intake
  • participant displays evidence of alcohol-related problems during program intake, as indicated by any of the following:

    • a report of physical IPV while under the influence of alcohol in the past year
    • a score of 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT)
    • consumption of 6 or more standard drinks per occasion on one or more occasions in the previous 6 months
    • average weekly consumption of 14 or more standard drinks in the prior 6 months
  • participant provides written consent to participate in the study
  • inclusion for this study is broad because this is a population who possesses a number of comorbid problems and exclusion for those based on psychopathology or risk for aggression could potentially lead to a biased sample

Exclusion Criteria:

  • None

Sites / Locations

  • Phoenix VA Health Care System, Phoenix, AZRecruiting
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  • VA Ann Arbor Healthcare System, Ann Arbor, MIRecruiting
  • Minneapolis VA Health Care System, Minneapolis, MNRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Motivational Enhancement Therapy

Alcohol Education Control

Telephone Monitoring

Arm Description

Motivational enhancement therapy for alcohol use problems, which includes empathic support, feedback and advice, strategies for enhancing self-efficacy, techniques for eliciting self-motivational statements from the participant, strategies for addressing participant ambivalence about change and participant resistance to change, and methods for eliciting and affirming commitment to a specific change plan (active intervention).

Psychoeducational intervention intended to: (1) dispel myths about the effects of alcohol, (2) provide information about the general risks of drinking and process of recovery from alcohol problems, (3) provide information about the specific risks related to family relationships and IPV, (4) offer self-help program information and related strategies to address drinking problems, (5) promote and encourage healthy decision-making, and (6) reinforce the benefits of abstinence or controlled drinking.

Brief supportive telephone monitoring sessions that are commonly delivered while Veterans wait to begin their groups (treatment as usual).

Outcomes

Primary Outcome Measures

Quantity/Frequency of Alcohol Consumption, Self-Report (QFV)
Participants will be shown a standard drink equivalent chart and will answer questions about their typical alcohol consumption quantity (in standard drink units) on weekdays and weekend days, typical drinking frequency (number of consumption days per week) on weekdays and weekend days, and the highest number of standard drinks consumed at a single occasion during the prior 3 months. If participants work unusual schedules, they will be asked to define the weekend as their day or days off from work. If participants report periods of abstinence and periods of drinking in the previous 3 months, the questions will pertain to periods of drinking. Scores will not be reported on a scale, so there are no minimum and maximum values to report.

Secondary Outcome Measures

Revised Conflict Tactics Scales (CTS2)
Intimate partner violence (IPV) will be measured using the CTS2, administered to the client regarding their IPV at baseline and follow-up assessments. We will administer only the Physical Assault (12 items) and Psychological Aggression (8 items) subscales to limit respondent burden and because these are most relevant to study hypotheses. The minimum value is 0 and the maximum value is 8. Higher scores represent higher rates of IPV, except for 7 and 8, which represent year and lifetime use and experience of IPV. Variety scores will be calculated for the CTS2 so that scores reflect the number of positively endorsed IPV behaviors (rather than estimates of IPV frequency). This scoring method is considered more reliable, less skewed, more balanced (since high frequency, less severe aggressive behaviors may outweigh the influence of more severe but less frequent violence), and less influenced by recall errors than other methods.

Full Information

First Posted
March 9, 2022
Last Updated
September 20, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05287711
Brief Title
Adjunctive Motivational Alcohol Intervention to Prevent IPV
Acronym
MET-SAH
Official Title
Adjunctive Motivational Alcohol Intervention to Prevent Intimate Partner Violence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
September 30, 2027 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a study to provide much-needed experimental data on the efficacy of a brief alcohol Motivational Enhancement Therapy (MET) pre-group intervention for Veterans receiving group treatment for IPV perpetration. The investigators will compare those assigned to receive this MET intervention to those receiving a 4-session Alcohol Education (AE) intervention or a standard treatment as usual (TAU) telephone monitoring intervention. The investigators will examine whether MET leads to greater reductions in alcohol use problems and IPV perpetration, and increased help-seeking behavior for alcohol use problems. Participants will be 300 male Veterans drawn from the Strength at Home IPV intervention program at three locations: the Minneapolis VA Medical Center, the Phoenix VA Healthcare System, and VA Ann Arbor Healthcare System.
Detailed Description
Veterans exposed to trauma are at elevated risk for perpetration of intimate partner violence (IPV) and for the development of alcohol-related problems. Despite commonly found associations between alcohol misuse and IPV, the investigators are aware of no prior research in Veterans examining the impact of adjunctive alcohol interventions for those receiving IPV intervention. The investigators propose to provide much-needed experimental data on the efficacy of a brief alcohol Motivational Enhancement Therapy (MET) pre-group intervention for Veterans receiving group treatment for IPV perpetration. More specifically, the investigators propose to examine whether those assigned to receive this MET intervention, relative to those receiving a 4-session Alcohol Education (AE) intervention or a standard treatment as usual (TAU) telephone monitoring intervention, evidence greater reductions in alcohol use problems and IPV perpetration, and increased help-seeking behavior for alcohol use problems. Participants will be 300 male Veterans drawn from the Strength at Home IPV intervention program at three locations: the Minneapolis VA Medical Center, the Phoenix VA Healthcare System, and VA Ann Arbor Healthcare System. Participants will be randomized to their pre-group conditions and then assigned to Strength at Home groups for IPV, and will receive referrals for substance use treatment in the VA system or the community. Participants with clinically relevant alcohol use problems, as determined by baseline screening measures, will complete assessments of alcohol use, readiness to change, IPV and help-seeking behavior at baseline, post IPV intervention group (3 months after completion of 4-session alcohol intervention), and four separate 3-month follow-ups after the post-treatment assessment. Differences between conditions on the major outcome variables involving alcohol use, IPV, help-seeking, and treatment engagement will be examined with random-effects regression models using an intent-to-treat approach. Study findings may assist in enhancing the efficacy of IPV interventions for the Veteran population to help ensure the safety and well-being of Veterans and their families.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use and Intimate Partner Violence
Keywords
Intimate Partner Violence, Alcohol Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will receive motivational enhancement therapy for alcohol use problems and this will be compared to an alcohol psychoeducational intervention.
Masking
Outcomes Assessor
Masking Description
Assessors will be masked.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motivational Enhancement Therapy
Arm Type
Experimental
Arm Description
Motivational enhancement therapy for alcohol use problems, which includes empathic support, feedback and advice, strategies for enhancing self-efficacy, techniques for eliciting self-motivational statements from the participant, strategies for addressing participant ambivalence about change and participant resistance to change, and methods for eliciting and affirming commitment to a specific change plan (active intervention).
Arm Title
Alcohol Education Control
Arm Type
Experimental
Arm Description
Psychoeducational intervention intended to: (1) dispel myths about the effects of alcohol, (2) provide information about the general risks of drinking and process of recovery from alcohol problems, (3) provide information about the specific risks related to family relationships and IPV, (4) offer self-help program information and related strategies to address drinking problems, (5) promote and encourage healthy decision-making, and (6) reinforce the benefits of abstinence or controlled drinking.
Arm Title
Telephone Monitoring
Arm Type
Other
Arm Description
Brief supportive telephone monitoring sessions that are commonly delivered while Veterans wait to begin their groups (treatment as usual).
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy
Other Intervention Name(s)
MET
Intervention Description
In Session 1, the therapist provides personalized feedback on a range of assessment variables, including alcohol consumption levels, negative consequences from alcohol use, and family risk of alcoholism. Sessions 2-4 are follow-through sessions in which the therapist attempts to help the Veteran participant establish or reaffirm a commitment to an action plan for addressing alcohol concerns.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol Education Control
Other Intervention Name(s)
AE
Intervention Description
Will consist of 4 weekly individual sessions, approximately 60 minutes each. AE therapists will explain that their job is to provide the Veteran participants with information and education about the effects of alcohol, and that it is up to the Veteran participant to use this information as he sees fit. In each session, the Veteran participant will watch an educational videotape in a comfortable consulting room and will be given an opportunity to discuss the videotape with the project therapist for approximately 10 minutes. Written educational materials will supplement the information provided in the videos, and the therapist will ask several structured questions to determine whether the Veteran participant understood the material presented in the video.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
TAU
Intervention Description
Supportive telephone monitoring sessions that ensure equal spacing between assessments across conditions and equal number of therapist contacts.
Intervention Type
Behavioral
Intervention Name(s)
Strength at Home
Other Intervention Name(s)
SAH
Intervention Description
IPV intervention which consists of 12 weekly, 2-hour cognitive-behavioral sessions offered in a closed group format and co-led by doctoral level male and female therapists. Strength at Home is based on a social information processing model of trauma and IPV and provides material covering psychoeducation regarding trauma and IPV, conflict and anger management skills, assertiveness training, and skills in stress management and communication.
Primary Outcome Measure Information:
Title
Quantity/Frequency of Alcohol Consumption, Self-Report (QFV)
Description
Participants will be shown a standard drink equivalent chart and will answer questions about their typical alcohol consumption quantity (in standard drink units) on weekdays and weekend days, typical drinking frequency (number of consumption days per week) on weekdays and weekend days, and the highest number of standard drinks consumed at a single occasion during the prior 3 months. If participants work unusual schedules, they will be asked to define the weekend as their day or days off from work. If participants report periods of abstinence and periods of drinking in the previous 3 months, the questions will pertain to periods of drinking. Scores will not be reported on a scale, so there are no minimum and maximum values to report.
Time Frame
Baseline, post-treatment, three-month, six-month, nine-month, and twelve-month follow-ups
Secondary Outcome Measure Information:
Title
Revised Conflict Tactics Scales (CTS2)
Description
Intimate partner violence (IPV) will be measured using the CTS2, administered to the client regarding their IPV at baseline and follow-up assessments. We will administer only the Physical Assault (12 items) and Psychological Aggression (8 items) subscales to limit respondent burden and because these are most relevant to study hypotheses. The minimum value is 0 and the maximum value is 8. Higher scores represent higher rates of IPV, except for 7 and 8, which represent year and lifetime use and experience of IPV. Variety scores will be calculated for the CTS2 so that scores reflect the number of positively endorsed IPV behaviors (rather than estimates of IPV frequency). This scoring method is considered more reliable, less skewed, more balanced (since high frequency, less severe aggressive behaviors may outweigh the influence of more severe but less frequent violence), and less influenced by recall errors than other methods.
Time Frame
Baseline, post-treatment, three-month, six-month, nine-month, and twelve-month follow-ups

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All male Veteran participants must meet the following eligibility criteria: participant is a Veteran minimum age 18 participant is enrolled in the Strength at Home program following program intake participant displays evidence of alcohol-related problems during program intake, as indicated by any of the following: a report of physical IPV while under the influence of alcohol in the past year a score of 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT) consumption of 6 or more standard drinks per occasion on one or more occasions in the previous 6 months average weekly consumption of 14 or more standard drinks in the prior 6 months participant provides written consent to participate in the study inclusion for this study is broad because this is a population who possesses a number of comorbid problems and exclusion for those based on psychopathology or risk for aggression could potentially lead to a biased sample Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Casey T Taft, PhD
Phone
(857) 364-4344
Ext
44344
Email
Casey.Taft@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Anissa N Garza
Email
Anissa.Garza@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Casey Tyler Taft, PhD
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix VA Health Care System, Phoenix, AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandi L. Luedtke, PsyD
Phone
602-234-7158
Email
Brandi.Luedtke1@va.gov
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130-4817
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casey T Taft, PhD
Phone
(857) 364-4344
Ext
44344
Email
Casey.Taft@va.gov
First Name & Middle Initial & Last Name & Degree
Anissa N Garza
Email
Anissa.Garza@va.gov
First Name & Middle Initial & Last Name & Degree
Casey Tyler Taft, PhD
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105-2303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Winters, PhD
Phone
734-222-7651
Email
Jamie.Winters@va.gov
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417-2309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noah Venables, PhD
Phone
612-629-7422
Email
Noah.Venables@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.strengthathome.org
Description
Strength at Home website

Learn more about this trial

Adjunctive Motivational Alcohol Intervention to Prevent IPV

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