Alcohol MisusePhase 1+Change SailorNCT07858305
Positive Change for Sailors
A Phase 1 study testing Positive Change© for Sailors in people with Alcohol Misuse and Sexual Assault, run by Naval Health Research Center at 4 sites in United States.
Trial summary
Alcohol use and sexual violence are significant public health issues affecting military personnel. This study includes a pilot randomized control trial of Positive Change© for Sailors, an integrated alcohol and sexual assault prevention program tailored to U.S. Navy personnel. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Misuse, Sexual Assault
- What is being tested?
- Positive Change© for Sailors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2026to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Active duty
- Navy service branch
- Enlisted rank
- Ages 18-24
Who cannot join
- Not active duty
- Serving in a military branch other than the Navy
- Not of enlisted rank (e.g., Commissioned officer, Warrant officer)
- Under 18 years of age
- Over 24 years of age
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Georgia State University
Atlanta, Georgia, 30303
Rhode Island Hospital
Providence, Rhode Island, 02903
Naval Health Research Center
San Diego, California, 92106
Arizona State University
Tempe, Arizona, 85281
About this study
Official title: Evaluating Positive Change for Sailors: A Web-based Sexual Assault Prevention Program
Alcohol use and sexual violence are significant public health issues affecting military personnel. This study includes a pilot randomized control trial of Positive Change© for Sailors, an integrated alcohol and sexual assault prevention program tailored to U.S. Navy personnel. Active duty Sailors aged 18-24 will be randomized to receive Positive Change© for Sailors or an assessment-only control condition. Analyses will be conducted to assess feasibility and examine preliminary differences in behavior, perceived norms, and related attitudes immediately following the program and at a three month follow-up assessment.
Read the detailed description
The purpose of the project is to test the Positive Change© for Sailors program through a pilot randomized controlled trial (RCT).
The objective is to assess feasibility and examine preliminary differences in behavioral, perceived norms, and attitudes/self-efficacy outcomes using baseline, post-program, and 3-month follow-up assessments in a pilot RCT. Feasibility of Positive Change© for Sailors will be assessed through successful recruitment and retention of 75% of the sample. Feasibility will also be measured through time spent on each component. Preliminary efficacy will be assessed via changes in primary outcome measures.
Primary outcome measures include changes in behavior (frequency of alcohol use, sexual assault victimization, sexual assault perpetration, and bystander intervention), perceived norms (alcohol use and sexual assault), and related attitudes/self-efficacy outcomes.
It is hypothesized that Positive Change© for Sailors will be deemed feasible and show preliminary efficacy in a pilot RCT of 120 Sailors randomly assigned to either the Positive Change© for Sailors program or an assessment-only control condition. While the primary expected outcomes of the pilot RCT pertain to feasibility and the study is not powered to conduct formal hypothesis testing, preliminary analyses will be performed to assess trends and relative group changes.
Exploratory analyses will evaluate trends of changes in perceived norms for alcohol use and sexual assault as a potential mechanism of change (mediator) of behavioral and attitudinal changes. Exploratory analyses will also examine the role of prior history of sexual victimization/aggression as a moderator of behavioral and attitudinal changes.
- Conditions
- Alcohol Misuse, Sexual Assault
- Being tested
- Positive Change© for Sailors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Change© for SailorsBehavioural
Also called +Change, Positive Change
Positive Change© for Sailors is a multipronged, integrated program addressing alcohol misuse, sexual assault victimization risk, sexual assault perpetration, and bystander intervention among Sailors. It uses social norms-based personalized feedback and is tailored based on sex.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This is an assessment only control condition |
| Positive Change© for Sailors | Experimental | This is an integrated social norms-based personalized feedback intervention for Sailors. This intervention targets alcohol misuse, sexual assault victimization risk, sexual assault perpetration, and bystander intervention among Sailors. Receives: Behavioral: Positive Change© for Sailors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use
Alcohol use quantity and frequency will be assessed using the Daily Drinking Questionnaire. Participants indicate the number of drinks they typically consume for each day of the week, and the number of hours over which the alcohol is consumed. Higher scores indicate higher alcohol use.
Measured: Baseline, 3-month follow-up
Sexual assault victimization
Sexual assault victimization and severity of victimization will be assessed using the Sexual Experiences Survey - Short Form Victimization, which will assess experience of nonconsensual sexual experiences. This will be modified to assess experiences both prior to military service and since entering military. Responses are rated on number of times each experience occurred (0, 1, 2, 3+). Higher scores indicate higher sexual assault victimization.
Measured: Baseline, 3-month follow-up
Sexual Violence Perpetration
Sexual violence perpetration will be assessed using a modified version of the Sexual Strategies Scale. Participants check all items that apply. Higher scores indicate more sexual violence perpetration.
Measured: Baseline, 3-month follow-up
Bystander Intervention Behavior
Bystander intervention behavior will be assessed using the Bystander Behavior Scale. Responses indicate if the participant engaged in each bystander behavior with a friend or not, or if they had no opportunity to engage in the behavior. Higher scores indicate higher bystander intervention behaviors.
Measured: Baseline, 3-month follow-up
Secondary outcomes (9)
Program Satisfaction
Program satisfaction will be assessed using items developed by the research team. Items will assess the acceptability, satisfaction, and perceived utility of the intervention. Higher scores indicate higher program satisfaction.
Measured: Immediately after the intervention (intervention group only)
Motivation to Change
Motivation to change will be assessed using the Contemplation Ladder. Participants report the stage that best represents their willingness to change drinking behaviors. Higher scores indicate higher willingness to change.
Measured: Baseline, immediately after the intervention (intervention group only)
Bystander Intentions
Bystander intentions will be assessed using the Sexual Social Norms Inventory - Bystander Intervention subscale. Participants rate the extent to which they agree that they would engage in each bystander scenario on a scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate higher intentions to engage in bystander behaviors.
Measured: Baseline, immediately after the intervention (intervention group only), 3-month follow-up
Perceived Drinking Norms
Drinking norms will be assessed using a modified version of the Drinking Norms Rating Form. The modified version assesses perceived typical drinks consumed per drinking occasion and perceived typical drinking per week for Sailors of the same sex. Higher scores indicate more perceived alcohol consumption.
Measured: Baseline, immediately after the intervention (intervention group only), 3-month follow-up
Perceived Sexual Norms
Perceived Sexual Norms will be evaluated using items developed by the research team. The items assess the extent to which the participant perceives that most Sailors would engage in various behaviors regarding sexual activity. Items are reported on a scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate healthier perceived sexual norms.
Measured: Baseline, immediately after the intervention (intervention group only), 3-month follow-up
Rape Attributions
Rape attributions will be assessed using the Rape Attribution Questionnaire. Participants who experienced a sexual assault are asked to indicate how often they have attributed their assault to various reasons on a scale from 0 (never) to 4 (very often). Higher scores indicate higher rape attribution.
Measured: Baseline, 3-month follow-up
Attitudes Regarding Sexual Consent
Attitudes regarding sexual consent will be assessed using items from the Sexual Consent Scale. Participants rate the extent to which they agree with each item on a scale from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate healthier attitudes regarding sexual consent.
Measured: Baseline, 3-month follow-up
Rape Myth Acceptance
Rape myth acceptance will be assessed using a modified version of the Illinois Rape Myth Acceptance Scale. Participants rate how strongly they agree with each rape myth on a scale from 1 (strongly agree) to 5 (strongly disagree). Items are reversed scored; higher scores indicate higher rape myth acceptance.
Measured: Baseline, 3-month follow-up
Sexual Assault Risk Perceptions
Sexual assault risk perceptions will be assessed using items developed by the research team. Participants will rate how likely they are to use each response strategy in a sexual assault scenario on a scale from 1 (very unlikely) to 5 (very likely). Higher scores indicate higher likelihood of strategy use.
Measured: Baseline, 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol MisuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naval Health Research Center
- Sponsor type
- US federal agency
- Collaborators
- Georgia State University, Arizona State University, Rhode Island Hospital, Leidos
- Responsible party
- Principal investigator, Kristen Walter, Naval Health Research Center
- Investigators
- Kristen H Walter, PhD, Principal investigator, Naval Health Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858305
- Sponsor's protocol ID
- NHRC.2026.0003
- Other IDs
- MO250144
- Acronym
- +Change Sailor
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and/or analyzed during the current study will not be publicly available due to personally identifiable information regulations, but they may be made available by the central contact on reasonable request and approval by the Naval Health Research Center Institutional Review Board/Privacy Office.
Publications
Gilmore AK, Nielsen KE, Salamanca NK, Oesterle DW, Parekh A, Leone RM, Orchowski LM, Ramakrishnan V, Kaysen D, Davis KC. Preliminary Efficacy of Positive Change(+Change): A Pilot Randomized Controlled Trial of an Integrated Alcohol and Sexual Assault Prevention Program Tailored by Gender and Sexual Orientation. J Interpers Violence. 2025 Jun;40(11-12):2556-2581. doi: 10.1177/08862605241275994. Epub 2024 Sep 27.
PubMed 39329408Gilmore AK, Leone RM, Oesterle DW, Davis KC, Orchowski LM, Ramakrishnan V, Kaysen D. Web-Based Alcohol and Sexual Assault Prevention Program With Tailored Content Based on Gender and Sexual Orientation: Preliminary Outcomes and Usability Study of Positive Change (+Change). JMIR Form Res. 2022 Jul 22;6(7):e23823. doi: 10.2196/23823.
PubMed 35867393
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Positive Change for Sailors: A Web-based Sexual Assault Prevention Program
- ClinicalTrials.gov ID
- NCT07858305
- Acronym / sponsor ID
- +Change Sailor / NHRC.2026.0003
- Conditions
- Alcohol Misuse, Sexual Assault
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Naval Health Research CenterUS federal agency
- Collaborators
- Georgia State University, Arizona State University, Rhode Island Hospital, Leidos
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alcohol use and sexual violence are significant public health issues affecting military personnel. This study includes a pilot randomized control trial of Positive Change© for Sailors, an integrated alcohol and sexual assault prevention program tailored to U.S. Navy personnel. Active duty Sailors aged 18-24 will be randomized to receive Positive Change© for Sailors or an assessment-only control condition. Analyses will be conducted to assess feasibility and examine preliminary differences in behavior, perceived norms, and related attitudes immediately following the program and at a three month follow-up assessment.
Detailed description
The purpose of the project is to test the Positive Change© for Sailors program through a pilot randomized controlled trial (RCT).
The objective is to assess feasibility and examine preliminary differences in behavioral, perceived norms, and attitudes/self-efficacy outcomes using baseline, post-program, and 3-month follow-up assessments in a pilot RCT. Feasibility of Positive Change© for Sailors will be assessed through successful recruitment and retention of 75% of the sample. Feasibility will also be measured through time spent on each component. Preliminary efficacy will be assessed via changes in primary outcome measures.
Primary outcome measures include changes in behavior (frequency of alcohol use, sexual assault victimization, sexual assault perpetration, and bystander intervention), perceived norms (alcohol use and sexual assault), and related attitudes/self-efficacy outcomes.
It is hypothesized that Positive Change© for Sailors will be deemed feasible and show preliminary efficacy in a pilot RCT of 120 Sailors randomly assigned to either the Positive Change© for Sailors program or an assessment-only control condition. While the primary expected outcomes of the pilot RCT pertain to feasibility and the study is not powered to conduct formal hypothesis testing, preliminary analyses will be performed to assess trends and relative group changes.
Exploratory analyses will evaluate trends of changes in perceived norms for alcohol use and sexual assault as a potential mechanism of change (mediator) of behavioral and attitudinal changes. Exploratory analyses will also examine the role of prior history of sexual victimization/aggression as a moderator of behavioral and attitudinal changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This is an assessment only control condition |
| Positive Change© for Sailors | Experimental | Behavioral: Positive Change© for SailorsThis is an integrated social norms-based personalized feedback intervention for Sailors. This intervention targets alcohol misuse, sexual assault victimization risk, sexual assault perpetration, and bystander intervention among Sailors. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Active duty
- Navy service branch
- Enlisted rank
- Ages 18-24
Key exclusion criteria (5 listed)
- Not active duty
- Serving in a military branch other than the Navy
- Not of enlisted rank (e.g., Commissioned officer, Warrant officer)
- Under 18 years of age
- Over 24 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Change© for SailorsAlso: +Change, Positive ChangePositive Change© for Sailors is a multipronged, integrated program addressing alcohol misuse, sexual assault victimization risk, sexual assault perpetration, and bystander intervention among Sailors. It uses social norms-based personalized feedback and is tailored based on sex. | Behavioural | Positive Change© for Sailors |
Primary outcome
Alcohol use
Time frame: Baseline, 3-month follow-up
Alcohol use quantity and frequency will be assessed using the Daily Drinking Questionnaire. Participants indicate the number of drinks they typically consume for each day of the week, and the number of hours over which the alcohol is consumed. Higher scores indicate higher alcohol use.
Sexual assault victimization
Time frame: Baseline, 3-month follow-up
Sexual assault victimization and severity of victimization will be assessed using the Sexual Experiences Survey - Short Form Victimization, which will assess experience of nonconsensual sexual experiences. This will be modified to assess experiences both prior to military service and since entering military. Responses are rated on number of times each experience occurred (0, 1, 2, 3+). Higher scores indicate higher sexual assault victimization.
Sexual Violence Perpetration
Time frame: Baseline, 3-month follow-up
Sexual violence perpetration will be assessed using a modified version of the Sexual Strategies Scale. Participants check all items that apply. Higher scores indicate more sexual violence perpetration.
Bystander Intervention Behavior
Time frame: Baseline, 3-month follow-up
Bystander intervention behavior will be assessed using the Bystander Behavior Scale. Responses indicate if the participant engaged in each bystander behavior with a friend or not, or if they had no opportunity to engage in the behavior. Higher scores indicate higher bystander intervention behaviors.
9 secondary outcomes
Program Satisfaction
Time frame: Immediately after the intervention (intervention group only)
Motivation to Change
Time frame: Baseline, immediately after the intervention (intervention group only)
Bystander Intentions
Time frame: Baseline, immediately after the intervention (intervention group only), 3-month follow-up
Perceived Drinking Norms
Time frame: Baseline, immediately after the intervention (intervention group only), 3-month follow-up
Perceived Sexual Norms
Time frame: Baseline, immediately after the intervention (intervention group only), 3-month follow-up
Rape Attributions
Time frame: Baseline, 3-month follow-up
Attitudes Regarding Sexual Consent
Time frame: Baseline, 3-month follow-up
Rape Myth Acceptance
Time frame: Baseline, 3-month follow-up
Sexual Assault Risk Perceptions
Time frame: Baseline, 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 39329408Gilmore AK, Nielsen KE, Salamanca NK, Oesterle DW, Parekh A, Leone RM, Orchowski LM, Ramakrishnan V, Kaysen D, Davis KC. Preliminary Efficacy of Positive Change(+Change): A Pilot Randomized Controlled Trial of an Integrated Alcohol and Sexual Assault Prevention Program Tailored by Gender and Sexual Orientation. J Interpers Violence. 2025 Jun;40(11-12):2556-2581. doi: 10.1177/08862605241275994. Epub 2024 Sep 27.
- Background: PubMed 35867393Gilmore AK, Leone RM, Oesterle DW, Davis KC, Orchowski LM, Ramakrishnan V, Kaysen D. Web-Based Alcohol and Sexual Assault Prevention Program With Tailored Content Based on Gender and Sexual Orientation: Preliminary Outcomes and Usability Study of Positive Change (+Change). JMIR Form Res. 2022 Jul 22;6(7):e23823. doi: 10.2196/23823.
- Individual participant dataSharing planned: No. The datasets generated and/or analyzed during the current study will not be publicly available due to personally identifiable information regulations, but they may be made available by the central contact on reasonable request and approval by the Naval Health Research Center Institutional Review Board/Privacy Office.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristen H Walter, PhD principal investigator
Naval Health Research Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Positive Change© for Sailors in people with Alcohol Misuse and Sexual Assault, run by Naval Health Research Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen H Walter, PhD (619-540-4108, Kristen.h.Walter.civ@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol use (time frame: Baseline, 3-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07858305, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.