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

NCT06608979 | Recruiting

• 1 other identifier: 2016636
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Substance Use Disorders; Posttraumatic Stress Disorder; Opioid Use Disorder; Violence, Sexual; Violence, Gender-Based; Violence, Domestic

Keywords

prevention; peer support specialist; substance use disorders; posttraumatic stress disorder; interpersonal violence; intimate partner violence; sexual violence

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Sexual Experiences Survey Short Form Victimization

  Participants complete this measure at baseline, 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).

• PC-PTSD-5

  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)

  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)

  Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).

Study Arms (1)

Screening/Referral and Prevention

EXPERIMENTAL

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

Interventions

Screening/Referral and Prevention BEHAVIORAL

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)

Screening/Referral and Prevention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant identifies as female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Clemson University: lead
• Prisma Health-Upstate: collaborator

Study Sites (2)

Addiction Medicine Clinic, Prisma Health Upstate

Greenville, South Carolina, 29605, United States

RECRUITING

The Phoenix Center

Greenville, South Carolina, 29607, United States

RECRUITING

Related Publications (1)

• Zinzow HM, Pericot-Valverde I, Smalls L, Brancato MG, Chapman G, Smith A, Thompson A, Greco C, Shank M, Eichelberger KY, Smith K, Litwin AH. A Peer Support Specialist-Delivered Sexual and Intimate Partner Violence Prevention Program for Women in Substance Use Treatment: Protocol for a Single-Arm Trial. JMIR Res Protoc. 2025 Aug 8;14:e68673. doi: 10.2196/68673.

  PMID: 40779309 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Stress Disorders, Post-Traumatic; Opioid-Related Disorders; Coitus

Interventions

Mass Screening; Referral and Consultation

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Narcotic-Related Disorders; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Heidi Zinzow, Ph.D.

  Clemson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi Zinzow, Ph.D.

CONTACT

864-656-4376; hzinzow@clemson.edu

Lauren Smalls, B.S.

CONTACT

864-656-3210; ltsmall@clemson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm design with baseline, posttest, and follow-up assessments

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 23, 2024
• Study Start: June 11, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-06

Locations

US (2)