Alcohol-Involved Sexual Violence Prevention Strategies for College Students

(RAISE Trial)

Overseen By Elizabeth Walker

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Under 18, Not enrolled, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

2400 Participants Needed

Trial Summary

What is the purpose of this trial?

This cluster-randomized controlled trial across 28+ college campuses focuses on undergraduate college students at elevated risk for sexual violence and hazardous drinking (i.e., students with prior history of sexual violence, students who are sexual or gender minority, and students with disabilities). "Reducing Alcohol Involved Sexual violence in higher Education (RAISE)" is a longitudinal study that will test research-informed strategies to improve implementation of a prevention intervention in college health and counseling centers, integrate a safety decision aid (via computer or mobile device) to more directly target harm reduction among students particularly vulnerable to hazardous drinking and SV, and evaluate campus policies that increase accessibility and uptake of confidential services for students. This is the first study to situate a sexual violence prevention intervention in college health and counseling centers to address two significant public health concerns -- alcohol-involved sexual violence and hazardous drinking on college campuses.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment GIFTSS Training, Learning Collaborative, Mental Health Task-Sharing Training, Community-Engaged Multisector Collaborative Care Model, Provider Scripts?

Research shows that collaborative care, which is part of this treatment, can effectively improve mental health outcomes, especially for those with a history of trauma or multiple types of violent victimization. It has been shown to reduce symptoms of PTSD and depression and improve mental health scores in various settings. ^{1 2 3 4 5}

Is the collaborative care model safe for humans?

Collaborative care interventions, which involve healthcare providers like social workers and nurses, have been used safely in trauma centers to address both physical and mental health needs, including alcohol use and PTSD, suggesting they are generally safe for humans. ^{1 2 6 7 8}

How is the GIFTSS Training treatment different from other treatments for preventing alcohol-involved sexual violence among college students?

The GIFTSS Training treatment is unique because it involves training college health center staff to provide universal education on sexual violence and alcohol's role in it, aiming to make discussions about these topics more comfortable for both students and providers. This approach contrasts with other interventions that may focus solely on providing information about responsible drinking or target specific high-risk groups. ^{9 10 11 12 13}

Eligibility Criteria

This trial is for undergraduate students aged 18-24 enrolled at participating colleges who are seeking care at their campus health or counseling centers. It's not open to those under 18, not enrolled as undergraduates, or not using the college health services.

Inclusion Criteria

I am between 18 and 24 years old.

Seeking care at a participating campus college health or counseling center for any reason

Undergraduate student enrolled at participating college campus

Exclusion Criteria

Not enrolled as an undergraduate at a participating campus

I am younger than 18 years old.

Not seeking care at college health or counseling center

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Training for college health center clinicians and staff in implementation of GIFTSS Training combined with provider scripts and/or learning collaborative to support implementation

4 months

Initial training sessions and ongoing support

Follow-up

Participants are monitored for self-efficacy and use of harm reduction strategies, as well as SV victimization and alcohol use patterns

12 months

Follow-up assessments at 4 months and 12 months

Treatment Details

Interventions

• GIFTSS Training
• Learning Collaborative
• Provider Scripts

Trial Overview The RAISE study tests strategies in college health and counseling centers to prevent sexual violence and reduce hazardous drinking. It includes provider scripts, GIFTSS training, a learning collaborative approach, and integrates a safety decision aid for students.

Participant Groups

Group I: GIFTSS Training, Learning Collaborative, and Provider Scripts Experimental Treatment 3 Interventions

Training for college health center clinicians and staff in implementation of GIFTSS Training combined with learning collaborative as well as provider scripts to support implementation

Group II: GIFTSS Training and Provider Scripts Experimental Treatment 2 Interventions

Training for college health center clinicians and staff in implementation of GIFTSS Training combined with provider scripts to support implementation

Group III: GIFTSS Training and Learning Collaborative Experimental Treatment 2 Interventions

Training for college health center clinicians and staff in implementation of GIFTSS Training combined with learning collaborative to support implementation

Group IV: GIFTSS Training Only Active Control 1 Intervention

Training for college health center clinicians and staff in implementation of GIFTSS Training

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Findings from Research

Collaborative care strategies effectively integrate mental health interventions into trauma care, showing promise in reducing symptoms of PTSD and alcohol use among injured patients, based on initial randomized clinical trials.

These interventions can be feasibly implemented in trauma centers, linking immediate care to outpatient services, which may enhance the overall quality of mental health care for trauma victims.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative care interventions in general trauma patients. Petrie, M., Zatzick, D.[2023]

Collaborative care significantly improved mental health outcomes for patients with a history of multiple violent victimizations, particularly enhancing their mental component summary (MCS) scores at 3 and 6 months after intervention.

Patients with three to four types of violent victimization experienced much greater improvements in mental health scores compared to those without such histories, suggesting that collaborative care is especially beneficial for trauma-affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Collaborative Care Effects on the Mental and Physical Health of Patients With and Without Violent Victimization Histories. Hullenaar, KL., Rivara, FP., Wang, J., et al.[2023]

The 12-month Collaborative Care (CC) intervention showed that patients with poorly controlled Type 2 Diabetes (T2D) and depression were more likely to maintain significant improvements in depressive symptoms and glucose levels at 36 months compared to those receiving usual care.

While there were no overall differences in health outcomes between the CC and usual care groups at 36 months, patients in the CC group who had improved outcomes at 12 months were more likely to sustain those improvements, indicating the long-term benefits of the CC approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Effects of a Collaborative Care Model on Metabolic Outcomes and Depressive Symptoms: 36-Month Outcomes from the INDEPENDENT Intervention. Suvada, K., Ali, MK., Chwastiak, L., et al.[2023]

Collaborative care for common mental illnesses has been proven to be more effective than traditional care, yet it is not widely implemented due to challenges in adoption and dissemination of this model.

The authors highlight the importance of implementation science in overcoming barriers to integrating collaborative care into practice, emphasizing its potential to significantly expand mental health services in the United States.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large-Scale Dissemination of Collaborative Care and Implications for Psychiatry. Katzelnick, DJ., Williams, MD.[2015]

The collaborative practice model for bipolar disorder emphasizes patient engagement in illness management and joint decision-making, which may help bridge the gap between medication efficacy and real-world effectiveness.

The Bipolar Disorders Program (BDP) developed in the Veterans Affairs health care system shows promise in improving care processes and outcomes for bipolar disorder, with ongoing studies assessing its implementation across multiple sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The collaborative practice model for bipolar disorder: design and implementation in a multi-site randomized controlled trial. Bauer, MS.[2019]

The pilot Patient Safety Presentation process, implemented in a psychiatry residency program, significantly improved residents' knowledge and engagement in patient safety practices, as evidenced by pre- and post-presentation surveys involving 32 residents.

All participating residents expressed satisfaction with the presentation, highlighting its effectiveness as a model for enhancing patient safety education in residency programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Pilot of a Process for Regularly Sharing Summary Patient Safety Data. Kim, B., Grech, SM., Rembisz, AE., et al.[2023]

This qualitative study identified key clinical risks in mental health care, including violence and self-destructive behavior, treatment errors, and risks associated with mental illnesses, highlighting the unique challenges of clinical risk management (CRM) in this field.

The research emphasizes that psychiatric patients often do not recognize their illness, which complicates their treatment, and that staff safety is a critical concern in mental health settings, differing from CRM practices in physical health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical risk management in mental health: a qualitative study of main risks and related organizational management practices. Briner, M., Manser, T.[2021]

The study evaluated the cost-effectiveness of the learning collaborative model for implementing Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) across 13 groups in the southeastern U.S., finding that it costs about $18,679 to improve clinician competence in TF-CBT.

Despite the high cost for clinician training, the model was highly cost-effective in reducing trauma-related mental health symptoms in youth, with costs ranging from $5,318 to $6,548 for each unit decrease in symptoms, suggesting significant benefits for youth with traumatic stress disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based implementation of trauma-focused interventions for youth: Economic impact of the learning collaborative model. Dopp, AR., Hanson, RF., Saunders, BE., et al.[2022]

A brief intervention aimed at educating college health center staff about sexual violence led to increased self-efficacy in harm reduction strategies among students, indicating that training can empower students to better manage risks associated with sexual violence.

Students who received the intervention were significantly more likely to disclose experiences of sexual violence during their health visits, suggesting that effective training can improve communication and support for affected individuals, although it did not lead to increased use of related services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cluster Randomized Trial of a College Health Center Sexual Violence Intervention. Miller, E., Jones, KA., McCauley, HL., et al.[2021]

This study is a cluster randomized controlled trial involving 2292 college students across 28 campuses, aiming to evaluate a brief intervention designed to reduce alcohol-related sexual violence by providing universal education on sexual violence in college health centers.

The intervention seeks to improve recognition of sexual violence and related risks among students, with additional outcomes focusing on changes in victimization, disclosure, and use of support services for those who reported exposure to sexual violence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cluster-randomized trial of a college health center-based alcohol and sexual violence intervention (GIFTSS): Design, rationale, and baseline sample. Abebe, KZ., Jones, KA., Rofey, D., et al.[2019]

Female college drinkers identified that friends play a crucial role in preventing sexual victimization (SV) by employing strategies such as keeping tabs on each other and using signals to indicate danger.

Barriers to implementing these prevention strategies include intoxication, distractions, and concerns about social consequences, which interventions must address to be effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Qualitative Study on Friends and the Social Context of Sexual Victimization: Implications for Campus-Based Interventions. Blayney, JA., Jenzer, T., Read, JP., et al.[2022]

The SAFE program, designed for 25 heavy drinking college men, effectively combines personalized feedback and group workshops to educate participants about alcohol use, consent, and bystander intervention, showing promise in preventing sexual assault.

Preliminary assessments indicate that the SAFE program is feasible and acceptable, with positive feedback on its content and delivery, suggesting it could be a valuable intervention for reducing sexual aggression in high-risk drinking environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual Assault Prevention for Heavy Drinking College Men: Development and Feasibility of an Integrated Approach. Orchowski, LM., Barnett, NP., Berkowitz, A., et al.[2020]

A study involving 10 U.S. Army male soldiers revealed that bystander intervention can be an effective strategy for preventing sexual violence, with soldiers identifying key themes such as recognizing risk and labeling situations as problematic.

The findings suggest that intervention programs should focus on teaching soldiers nonaggressive strategies, as soldiers often anticipated physical confrontations, which could lead to further misconduct.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Analysis of Bystander Intervention Among Young Adult Male Soldiers Who Engage in At-Risk Drinking. Orchowski, LM., Oesterle, DW., Borsari, B., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Collaborative care interventions in general trauma patients. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Exploring Collaborative Care Effects on the Mental and Physical Health of Patients With and Without Violent Victimization Histories. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term Effects of a Collaborative Care Model on Metabolic Outcomes and Depressive Symptoms: 36-Month Outcomes from the INDEPENDENT Intervention. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Large-Scale Dissemination of Collaborative Care and Implications for Psychiatry. [2015]

5. Denmark pubmed.ncbi.nlm.nih.gov

The collaborative practice model for bipolar disorder: design and implementation in a multi-site randomized controlled trial. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Development and Pilot of a Process for Regularly Sharing Summary Patient Safety Data. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Clinical risk management in mental health: a qualitative study of main risks and related organizational management practices. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Community-based implementation of trauma-focused interventions for youth: Economic impact of the learning collaborative model. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Cluster Randomized Trial of a College Health Center Sexual Violence Intervention. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

A cluster-randomized trial of a college health center-based alcohol and sexual violence intervention (GIFTSS): Design, rationale, and baseline sample. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

A Qualitative Study on Friends and the Social Context of Sexual Victimization: Implications for Campus-Based Interventions. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Sexual Assault Prevention for Heavy Drinking College Men: Development and Feasibility of an Integrated Approach. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Qualitative Analysis of Bystander Intervention Among Young Adult Male Soldiers Who Engage in At-Risk Drinking. [2023]