Trauma Screening/Referral and Interpersonal Violence Prevention for Women with Substance Use Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder; Substance Use Disorders; Posttraumatic Stress Disorder; Violence, Domestic; Violence, Sexual; Violence, Gender-Based
• Intervention / Treatment: Behavioral: Screening/Referral and Prevention

Detailed Description

The majority of women entering substance use treatment have a trauma history, placing them at risk for revictimization and substance use relapse. 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, trauma-focused 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 demographics, trauma and sexual assault experiences, knowledge and attitudes towards sexual and intimate partner violence, protective behavioral strategies, and intervention satisfaction and engagement.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi Zinzow, Ph.D.; Phone Number: 864-656-4376; Email: hzinzow@clemson.edu
• Study Contact Backup: Name: Lauren Smalls, B.S.; Phone Number: 864-656-3210; Email: ltsmall@clemson.edu

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Addiction Medicine Clinic, Prisma Health Upstate
      • Contact: Leigh Huckins; Phone Number: 864-643-8567; Email: Elizabeth.Huckins@Prismahealth.org
    • Greenville, South Carolina, United States, 29607
      • Recruiting
      • The Phoenix Center
      • Contact: Kimbley Smith; Phone Number: 864-467-3790; Email: kimsmith@phoenixcenter.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1) Age 18 or higher;2) female gender identity; 3) currently engaged in substance use treatment or care (behavioral, peer support, pharmacological, medical)

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Exclusion Criteria:

1) Non-English-speaking; 2) acute physical and medical conditions that interfere with participation in educational sessions (e.g., active psychosis, suicidality).

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Screening/Referral and Prevention; 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.	Behavioral: Screening/Referral and Prevention; Session 1: One hour PTSD Screening/referral and Psychoeducation on interpersonal violence (consent, drug-and-alcohol-facilitated assault, intimate partner violence); Session 2: One hour sessions on Protective Behavioral Strategies for interpersonal violence (skills training)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ARC3 Consent Scale	This self-report scale assesses knowledge and attitudes towards consent in sexual situations. This is a 7-item scale with scores ranging from 7 to 35, with higher scores indicating more accurate perceptions and greater knowledge of consent (Swartout et al, 2019)	Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
Illinois Rape Myth Acceptance Scale-Short Form	This self-report scale assesses agreement with rape myths. We selected 10 items from the scale, with scores ranging from 10 to 70, with higher scores indicating higher agreement with rape myths. (Payne, Lonsway, & Fitzgerald, 1999).	Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).f
Attitudes Towards Dating Violence	This self-report scale consists of 3 items assessing agreement with violence-supportive attitudes in dating situations. Scores range from 3 to 15, with higher scores indicating greater agreement with violence-supportive norms. (Price et al., 1999)	Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
Dating Behavior Survey	This self-report scale consists of 17 items that assess perceived likelihood of engaging in protective behavioral strategies while dating. Scores range from 17 to 102, with higher scores indicating greater likelihood of engaging in protective behavioral strategies. Adapted from Breitenbecher, 2008.	Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
Coping Responses to Sexual Aggression	This self-report scale consists of 16 items assessing perceived likelihood of engaging in various coping strategies to resist sexual aggression. Scores range from 16 to 96, with higher scores indicating higher perceived likelihood of resistance. (Macy, Nurius, & Norris, 2007).	Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
Barriers to Resistance	This self-report scale consists of 13 items assessing perceived barriers to resisting sexual aggression. Scores range from 13 to 52, with higher scores indicating higher perceived barriers to resistance (Norris, Nurius, & Dimeff, 1996).	Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
Knowledge and Use of Resources	This self-report scale assesses 1) how aware participants are of various community resources and 2) whether resources have been accessed in the past month. The first 13 item awareness subscale results in total scores ranging from 13 to 65, with higher scores indicating higher levels of awareness. The second subscale results in scores ranging from 0 to 13, with higher scores indicating more resources accessed.	Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual Experiences Survey Short Form Victimization	This self-report survey consists of 30 items assessing experiences with various forms of sexual victimization over the past three months. Scores range from 0 to 30, with higher scores indicating more types of sexual victimization experiences endorsed.(Koss et al., 2007)	Participants complete this measure at baseline, 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
PC-PTSD-5	This self-report survey assesses past month posttraumatic stress disorder symptoms with 5 screener items. Scores range from 0 to 5, with higher scores inidicating higher likelihood of meeting criteria for PTSD.	Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
PHQ-2 (Depression)	This self-report survey consists of two depression screener items, with scores ranging from 0 to 6. Higher scores indicate higher likelihood of meeting criteria for major depressive episode over the last two weeks.	Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
CAGE-AID (Substance Use)	This self-report inventory assesses past three month symptoms of substance use disorders with 4 items. Scores range from 0 to 4, with higher scores indicating higher likelihood of meeting criteria for a current substance use disorder.	Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).

Collaborators and Investigators

• Sponsor: Clemson University
• Collaborators: Prisma Health-Upstate
• Investigators: Principal Investigator: Heidi Zinzow, Ph.D., Clemson University

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: prevention; sexual violence; substance use disorders; posttraumatic stress disorder; intimate partner violence; interpersonal violence; peer support specialist
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Trauma and Stressor Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Opioid-Related Disorders
• Other Study ID Numbers: 2016636

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No