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

Trial Summary

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 data supports the idea that Violence Prevention for Women with Substance Use Disorders is an effective treatment?

The available research shows that addressing violence along with drug use goals is important for women with both intimate partner violence and substance use disorders. A study on a web-based intervention called BSAFER found it to be feasible and acceptable among women in emergency departments. Additionally, research on integrated trauma-focused interventions, like Seeking Safety, indicates that these treatments are safe and do not lead to more negative events compared to non-trauma-focused interventions. This suggests that such treatments can be effective in helping women with substance use disorders and a history of trauma. ^{1 2 3 4 5}

What safety data exists for the treatment in the trial?

The research indicates that safety data for psychosocial interventions in substance use disorder trials is limited. Serious adverse events (SAEs) are often reported, but none were found to be study-related in a large trial. There is a need for better monitoring of adverse events in behavioral health trials, as current practices may not fully capture all potential risks. Standardized methods for assessing adverse events, like the SAFTEE, have been adapted for some studies, but are not widely used in behavioral health interventions. ^{6 7 8 9 10}

Is the treatment 'Screening/Referral and Prevention' promising for women with substance use disorders?

Yes, the treatment is promising because it addresses both substance use and violence, which are critical issues for women with substance use disorders. It helps identify and support women who have experienced trauma, which is common in this group, and can improve their overall health and treatment outcomes. ^{2 11 12 13 14}

What is the purpose of this trial?

The purpose of this project is to implement a pilot study to investigate the feasibility and preliminary efficacy of a peer support specialist delivered violence prevention program for women in substance use treatment. The program entails a posttraumatic stress disorder (PTSD) screening, resource referral, and two session interpersonal violence prevention protocol for 60 participants. In this single arm trial, women are recruited from three substance use treatment facilities. Participants complete baseline, post-intervention, one-month, and three-month follow-up assessments. Self-report surveys assess trauma exposure, knowledge and behaviors related to interpersonal violence, and intervention engagement.

Research Team

Heidi Zinzow, Ph.D.

Principal Investigator

Clemson University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Pathways to rearrest among court mandated female substance use treatment patients. [2018]

2. United States 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. [2018]

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

A randomized controlled trial of screening and brief interventions for substance misuse in reproductive health. [2019]

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

Adverse events in an integrated trauma-focused intervention for women in community substance abuse treatment. [2021]

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

Women with co-occurring disorders (COD): treatment settings and service needs. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

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

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? [2021]

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

The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field. [2019]

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

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle. [2021]

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

Posttraumatic Stress Disorder, Health Problems, and Depression Among African American Women in Residential Substance Use Treatment. [2022]

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

Facets of Male Violence Against Women With Substance Abuse Problems: Women With a Residence and Homeless Women. [2022]

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

Test of a conceptual model of partner aggression among women entering substance use disorder treatment. [2021]

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

Suicidality, aggression, and other treatment considerations among pregnant, substance-dependent women with posttraumatic stress disorder. [2021]