- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07261722
Collaborative Opportunities for Reducing Alcohol and Sexual Violence Together (COAST)
Harnessing the Power of Military Peers to Reduce Sexual Violence and Risky Drinking in Service Members
The goal of this clinical trial is to test if a modified peer-based motivational intervention (the Military PAIRS; MPAIRS) is reasonable and practical for military contexts. The main questions it aims to answer are:
- Does it works to reduce SV?
- Does it works to reduce risky drinking? To test this, participants will answer questions about their SV history and risky drinking. Then they will be given MPAIRS. After 1 month, they will be asked about their SV history and risky drinking again.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective of the proposed study is to adapt an innovative, peer-based motivational interview (PMI) that encourages and prepares peers to reduce sexual violence (SV) risk. Delivered to pairs of peers (dyads), the PMI will be designed to foster collaborative efforts to increase readiness for, and decrease barriers to helping behavior, and to teach and plan together for assault prevention skills. As the role of alcohol has been under-addressed in SV prevention efforts, the PMI also will explicitly attend to how intoxication may serve as a barrier to peer intervention, and strategies for overcoming this barrier. The completion of this project's aims will yield a novel intervention that capitalizes on the natural resource of military responsibility to decrease risk for sexual violence - a pervasive problem affecting a substantial portion of military service members in the U.S.
In Phase One of the study, twelve peer dyads will participate in the peer-based motivational interview (PMI). The study will compare the participants at baseline to themselves at a 1 month follow up on outcomes. The study will focus on whether effects are in the expected direction and whether the strength of effect sizes are of practical magnitude. It is expected that participants will demonstrate significant increases in readiness, and engagement in peer assault prevention behavioral skills (PAPBs), and demonstrate decreases in perceived barriers. Follow-up data will be utilized to provide a rich description of the role of alcohol in implementing PAPBs, and whether the PMI reduces the impact of alcohol use. In exploratory analyses, it will be examined whether the intervention may be associated with decreased assault risk, as well as decreased drinking.
In Phase Two of the study, twenty seven peer dyads will will participate in the peer-based motivational interview (PMI) and twenty seven peer dyads will receive a general health education control. We will compare groups on outcomes at post-intervention and at monthly follow-ups over a three-month period, and also examine within-subjects change. Given the developmental nature of the study and the smaller sample size, we will focus on whether effects are in the expected direction and whether the strength of effect sizes are of practical magnitude. We expect participants receiving the PMI to demonstrate significant increases in readiness, and engagement in peer-based protective behaviors and alcohol strategies, and decreases in perceived barriers (improved self-efficacy, relationship concerns) at post-intervention and over the 3-month follow-up. We will also use our follow-up data to provide a rich description of the role of alcohol in implementing PAPBs, and whether the PMI reduces alcohol's impact. In exploratory analyses, we will examine whether the intervention may be associated with decreased assault risk, as well as decreased drinking
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer P Read, Ph.D.
- Phone Number: 7166450193
- Email: jpread@buffalo.edu
Study Locations
-
-
New York
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Buffalo, New York, United States, 14260
- Recruiting
- University at Buffalo Department of Psychology
-
Contact:
- Jennifer P Read, Ph.D.
- Phone Number: 716-883-2574
- Email: jpread@buffalo.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Enlisted U.S. Navy service members on active duty status
- Meet criteria for risky drinking (i.e. score of 4+ for men, 2+ for women according to the AUDIT-C)
- Have an eligible peer and the pair must socialize together at least twice a month
Exclusion Criteria:
- Individuals who endorse evidence of withdrawal (Item 6 on the AUDIT)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peer-Based Motivational Interview (PMI) (Phase One)
Will participate in the Peer-Based Motivational Interview (PMI) intervention in Phase One
|
The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare service members to work together to reduce Sexual Violence (SV) risk.
This intervention will target ways that the peer dyad may support, encourage, and share responsibility with one another in protecting against SV.
The Peer-based MI (PMI) will then use the responsibility and relationship of peers as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior.
As part of this, the PMI will focus on the identification and implementation of skills peers can use to help one another prevent SV.
PMI will include a focused discussion of the ways drinking may impede helping efforts.
Moreover, the PMI will encourage service members to identify personal, specific strategies for reducing the effects of alcohol on helping.
|
|
Experimental: Peer-Based Motivational Interview (PMI) (Phase Two)
Will participate in the Peer-Based Motivational Interview (PMI) intervention in Phase Two
|
The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare service members to work together to reduce Sexual Violence (SV) risk.
This intervention will target ways that the peer dyad may support, encourage, and share responsibility with one another in protecting against SV.
The Peer-based MI (PMI) will then use the responsibility and relationship of peers as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior.
As part of this, the PMI will focus on the identification and implementation of skills peers can use to help one another prevent SV.
PMI will include a focused discussion of the ways drinking may impede helping efforts.
Moreover, the PMI will encourage service members to identify personal, specific strategies for reducing the effects of alcohol on helping.
|
|
Active Comparator: Health and Well-Being for All
The control group for Phase Two will be Health and Well-Being For All intervention.
|
This single-session intervention, is designed to be delivered to peers in a group or dyad-based format, examines social determinants of health and wellness across a variety of domains.
The intervention outlines a 6-step process for improving overall wellness.
The CDC offers a number of handouts and other materials (e.g., peer dialogue exercises, data cards) that accompany the didactic material.
In this study, the HWBA intervention will be delivered by a project interventionist.
The session will be designed to be time equivalent (90 minutes) to the MPAIRs intervention.
(Pember, 2018)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Readiness to intervene
Time Frame: In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.
|
10 item scale scored on a 5 point likert type scale with higher value indicating they are more ready to intervene on behalf of the other member of the dyad in areas of concern for abuse. Modeled after: Center for Evidence-Based Practices at Case Western Reserve University (2010). Readiness Ruler. Center for Evidence-Based Practices, Case Western Reserve University. |
In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.
|
|
Peer -Directed Bystander Behaviors Scale for Friends
Time Frame: In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.
|
44 item scale. The answers provided are yes/no/"I did not perceive an opportunity to do this" for each item in 3 different contexts (Friend, Stranger, Someone in Military). Each item is a situation that the participant may have been in to help someone in the past month. The participant reports if they did that helped, didn't help, or didn't have that situation for each context. Banyard, V. L., Moynihan, M. M., Cares, A. C., & Warner, R. A. (2014). How do we know if it works? Defining measurable outcomes in bystander-focused violence prevention. Psychology of Violence, 4(1), 101-115. |
In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.
|
|
Assault Protective Strategies
Time Frame: In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.
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20 item scale.
It is scored on a 4 point likert type scale with an option for "I prefer to not answer" and an option for "I did not perceive an opportunity to do this".
The scale is made up of items of strategies that people do either before going out, or while they are out to reduce risk for sexual assault.
The participant reports to what extent they use each strategy with a higher number meaning they use the strategy to a greater extent.
|
In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.
|
|
PBSS-20 Alcohol Protective Strategy
Time Frame: In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.
|
20 item scale. It is scored on a 6 point likert type scale. The scale is made up of items of different strategies people often use to protect against negative consequences of alcohol use. The participant reports to what extent they use each strategy with a higher number meaning they use the strategy to a greater extent. Treloar H, Martens MP, McCarthy DM. The Protective Behavioral Strategies Scale-20: improved content validity of the Serious Harm Reduction subscale. Psychol Assess. 2015 Mar;27(1):340-6. doi: 10.1037/pas0000071. |
In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sexual Assault Experiences
Time Frame: In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.
|
Revised Sexual Experiences Survey (R-SES) will be used to assess how many times different sexual assault situations have occurred over the last month.
The number of events will be added together to give the number of times the participant was assaulted.
|
In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.
|
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Change in Drinking
Time Frame: In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.
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Using a grid-based average assessment measure based in the Daily Drinking Questionnaire, participants will report on alcohol consumption.
Higher scores indicate greater alcohol consumption.
|
In Phase 1, at baseline and 4 week follow up. In Phase 2, at baseline, 1 month follow up, 2 month follow up, and 3 month follow up.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jennifer P Read, Ph.D., University at Buffalo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Amino Acids, Peptides, and Proteins
- Proteins
- Enzymes
- Enzymes and Coenzymes
- Population Characteristics
- Transferases
- Protein Serine-Threonine Kinases
- Protein Kinases
- Phosphotransferases (Alcohol Group Acceptor)
- Phosphotransferases
- Intracellular Signaling Peptides and Proteins
- Neoplasm Proteins
- raf Kinases
- MAP Kinase Kinase Kinases
- Proto-Oncogene Proteins
- Oncogene Proteins
- Health
- Proto-Oncogene Proteins c-raf
Other Study ID Numbers
- 00006595
- TP210286 (Other Grant/Funding Number: U.S. Department Of Defense)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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