Violence Prevention for Women with Substance Use Disorders

Recruiting at 1 trial location

Overseen By Lauren Smalls, B.S.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Clemson University

Disqualifiers: Non-English-speaking, Active psychosis, Suicidality

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

Compensation: Varies

Number of Visits: 6

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a program designed to prevent violence against women undergoing treatment for substance use disorders. The program, called Screening/Referral and Prevention, includes a PTSD screening and two sessions with a peer support specialist focused on preventing interpersonal violence. Women in substance use treatment who identify as female and are 18 or older might be suitable candidates. Participants will complete surveys to assess their trauma exposure and program engagement. As an unphased trial, this study allows participants to contribute to important research that could shape future interventions.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since participants must be currently engaged in substance use treatment, it seems likely that you can continue your existing medications.

What prior data suggests that this violence prevention program is safe for women with substance use disorders?

Research has shown that the treatment used in this trial—screening and referral for women with substance use issues—is generally easy for participants to handle. Studies have found that programs involving PTSD (posttraumatic stress disorder) screenings and resource referrals do not cause harm. They aim to help participants find the right support.

This approach resembles SBIRT (Screening, Brief Intervention, and Referral to Treatment), a common method for identifying risky substance use. SBIRT has a strong safety record, indicating that screenings and referrals are safe for participants.

In short, evidence suggests that this treatment is safe, with no significant negative effects reported in similar programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this intervention for women with substance use disorders because it combines a targeted approach with personalized support. Unlike standard treatments that primarily focus on managing substance use alone, this method includes a brief PTSD screening and a direct connection to trauma-focused resources, addressing the underlying trauma that often accompanies substance use. Additionally, the two-session educational program delivered by peer support specialists empowers participants with essential skills to prevent interpersonal violence, offering a holistic approach to recovery and safety. This integration of trauma-informed care with peer support is what sets it apart and could lead to more comprehensive and effective outcomes.

What evidence suggests that this program is effective for violence prevention in women with substance use disorders?

Research shows that programs for addressing intimate partner violence (IPV) have been developed, but they are not always used equally. In this trial, participants will receive a brief PTSD screening and a warm handoff to trauma-focused resources if they screen positive, along with a two-session educational program on interpersonal violence prevention delivered by a peer support specialist. Studies suggest that screening for PTSD and offering help can benefit women dealing with substance use issues. These programs often include lessons on preventing violence and have shown promise in improving knowledge and behaviors related to violence. Surveys from participants indicate increased engagement and a better understanding of trauma and violence prevention after these programs. While more research is needed, early findings suggest that combining PTSD screenings and peer support education can assist women in substance use treatment. ^{1 2 3 6 7}

Who Is on the Research Team?

Heidi Zinzow, Ph.D.

Principal Investigator

Clemson University

Are You a Good Fit for This Trial?

This trial is for women over 18 who identify as female and are currently in substance use treatment. They must be able to participate in educational sessions, meaning they can't have acute conditions like active psychosis or suicidality, and they need to speak English.

Inclusion Criteria

Currently engaged in substance use treatment or care (behavioral, peer support, pharmacological, medical)

I identify as female.

Exclusion Criteria

Non-English-speaking

Acute physical and medical conditions that interfere with participation in educational sessions (e.g., active psychosis, suicidality)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Intervention

Participants receive a PTSD screening, resource referral, and a two-session interpersonal violence prevention program

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention with assessments at multiple time points

18 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Screening/Referral and Prevention

Trial Overview The study tests a violence prevention program delivered by peer support specialists. It includes PTSD screening, resource referral, and two sessions on preventing interpersonal violence. Participants will complete surveys before the program starts, after it ends, one month later, and three months later.

How Is the Trial Designed?

Group I: Screening/Referral and Prevention Experimental Treatment 1 Intervention

Participants will receive a brief PTSD screening, warm handoff to trauma-focused resources if screening positive, and two session peer support specialist-delivered educational program on interpersonal violence prevention.

Who Is Running the Clinical Trial?

Clemson University

Lead Sponsor

Trials

38

Recruited

8,200+

Prisma Health-Upstate

Collaborator

Trials

91

Recruited

47,500+

Published Research Related to This Trial

In a study of 105 pregnant women with substance use disorders, those with PTSD exhibited significantly higher levels of suicidality, aggression, and psychosocial impairment compared to those with other psychiatric disorders or no comorbidity.

The findings suggest that treatment for substance-dependent women with PTSD needs to address a broader range of severe issues, indicating a unique and more complex relationship between PTSD and substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicidality, aggression, and other treatment considerations among pregnant, substance-dependent women with posttraumatic stress disorder. Eggleston, AM., Calhoun, PS., Svikis, DS., et al.[2021]

In a study of 104 African American women in residential treatment for substance use disorders, 94.2% reported experiencing at least one trauma, and over half (51.0%) met the criteria for PTSD, indicating a high prevalence of trauma-related issues in this population.

A subset of screening items was identified that could effectively indicate probable PTSD, achieving a sensitivity of 88.7% and an accuracy of 77.9%, suggesting that brief screenings could help in the timely identification and treatment of PTSD alongside substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic Stress Disorder, Health Problems, and Depression Among African American Women in Residential Substance Use Treatment. Meshberg-Cohen, S., Presseau, C., Thacker, LR., et al.[2022]

In a study of 381 women mandated to enter substance use treatment, those with lower education levels and higher substance use severity before treatment were at a greater risk for relapse.

Women who relapsed were nearly three times more likely to be rearrested within 12 months after treatment, highlighting the need for tailored services that address these risk factors to improve treatment outcomes and reduce recidivism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathways to rearrest among court mandated female substance use treatment patients. Kopak, AM., Proctor, SL., Hoffmann, NG.[2018]

In a study involving 353 women in substance abuse treatment, the integrated PTSD treatment (Seeking Safety) did not result in significantly more adverse events compared to a non-trauma-focused intervention (Women's Health Education), indicating that it is safe to implement PTSD treatment in these settings.

Both interventions had low rates of adverse events (9.6% for Seeking Safety and 7.2% for Women's Health Education), suggesting that addressing PTSD in substance abuse programs does not worsen psychiatric or substance use symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in an integrated trauma-focused intervention for women in community substance abuse treatment. Killeen, T., Hien, D., Campbell, A., et al.[2021]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

The BSAFER program, a Web-based intervention for women facing intimate partner violence and substance use disorders, showed high feasibility and acceptability, with 98% of participants completing the program.

Participants in the BSAFER group experienced a small reduction in drug use, and those using drugs other than marijuana had greater decreases, suggesting the program may be beneficial for certain subgroups of women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BSAFER: A Web-based intervention for drug use and intimate partner violence demonstrates feasibility and acceptability among women in the emergency department. Choo, EK., Zlotnick, C., Strong, DR., et al.[2018]

A study involving 277 women entering substance use disorder treatment found that both partners' antisocial behavior and substance use significantly influence the risk of intimate partner violence (IPV), highlighting the interconnectedness of individual and relationship factors.

The research revealed that a woman's antisocial behavior can lead to increased physical IPV through her drug use and psychological IPV, while a man's antisocial behavior is linked to his own physical IPV through his drinking and relationship issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test of a conceptual model of partner aggression among women entering substance use disorder treatment. Schumm, JA., O'Farrell, TJ., Murphy, CM., et al.[2021]

The study found that both electronic and clinician-delivered 'screening, brief intervention, and referral to treatment' significantly reduced the number of days of primary substance use among women in reproductive health settings compared to enhanced usual care, with a sample size of 660 women.

Despite the reduction in substance use, there was no significant difference in the actual treatment use between the intervention groups and the enhanced usual care group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of screening and brief interventions for substance misuse in reproductive health. Martino, S., Ondersma, SJ., Forray, A., et al.[2019]

A study of 79 women with substance abuse issues found that 91% had experienced male violence, primarily from former partners, highlighting a significant link between substance abuse and exposure to violence.

Homeless women were particularly vulnerable, with a nearly fourfold increased risk of PTSD compared to women with residences, indicating the need for targeted public health interventions that address both violence and substance abuse in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facets of Male Violence Against Women With Substance Abuse Problems: Women With a Residence and Homeless Women. Beijer, U., Scheffel Birath, C., DeMartinis, V., et al.[2022]

There is a continuing need to enhance treatment and referral services for women with co-occurring disorders (COD), despite advancements in interventions over the past two decades.

The article highlights effective interventions such as centralized screening, trauma-informed integrated treatment, and process improvement strategies that can help tailor mental health and substance abuse treatments specifically for women with COD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women with co-occurring disorders (COD): treatment settings and service needs. Brown, VB., Melchior, LA.[2019]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

The COMBINE Study successfully adapted the Systematic Assessment for Treatment Emergent Events (SAFTEE) to standardize the assessment of adverse events for naltrexone and acamprosate in treating alcohol dependence, ensuring consistent and reliable data collection.

The SAFTEE demonstrated high fidelity and flexibility in measuring adverse events across various settings, suggesting it could be a valuable tool for future clinical studies evaluating the safety and efficacy of new therapeutic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field. Johnson, BA., Ait-Daoud, N., Roache, JD.[2019]

The Aggregate Safety Assessment Plan (ASAP) is designed to enhance safety planning and ongoing data review throughout a drug's life-cycle, promoting a systematic approach to understanding product safety.

By implementing the ASAP process, drug developers can improve early detection of safety signals, better characterize risks, and ensure consistent safety messaging across studies, ultimately aiding in informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle. Hendrickson, BA., Wang, W., Ball, G., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11217329/

Identifying best practices for substance-related intimate ... Results. Findings suggest that effective IPV screening and referral programs have been developed, but disparities in IPV screening exist and ...

2. withpower.com withpower.com/trial/phase-violence-sexual-5-2024-fff48

Violence Prevention for Women with Substance Use ... Participants receive a PTSD screening, resource referral, and a two-session interpersonal violence prevention program. 2 weeks. 2 visits (in-person). Follow-up.

3. ctv.veeva.com ctv.veeva.com/study/trauma-screening-referral-and-interpersonal-violence-prevention-for-women-with-substance-use-disorde

Trauma Screening/Referral and Interpersonal Violence ... Self-report surveys assess trauma exposure, knowledge and behaviors related to interpersonal violence, and intervention engagement.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834257

Substance Use Screening, Brief Intervention, and Referral ... The objective of this study was to describe screening practices for SUDs and opioid use disorders (OUDs) among youth-serving clinicians in the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0306460321003993

Intimate partner violence as a predictor of substance use ... This is the first systematic review of the literature on IPV as a predictor of substance use behaviors and treatment outcomes among women.

6. oasas.ny.gov oasas.ny.gov/sbirt

SBIRT: Screening, Brief Intervention & Referral to Treatment SBIRT is an evidence-based approach to identify individuals who use alcohol and other drugs (substances) at risky levels.

7. formative.jmir.org formative.jmir.org/2024/1/e49557

Web-Based Screening, Brief Intervention, and Referral to ... This study aims to assess the usability and acceptability of a web-based SBIRT called CHAT (Choices For Your Health After Trauma) tailored to address traumatic ...