Recruiting

Observational Study

Sponsor:

Clemson University

Code:

NCT06608979

Conditions

Substance Use Disorders

Posttraumatic Stress Disorder

Opioid Use Disorder

Violence, Sexual

Violence, Gender-Based

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Screening/Referral and Prevention

Study Details

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

Study ID

NCT06608979

Start date

Jun 11, 2024

Status verified date

Jun, 2024

Completion date

Mar, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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)

-

Exclusion Criteria:

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

-

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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)

Primary outcome measure

  • ARC3 Consent Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks). ]

Central Contacts and Locations

Central contacts

Heidi Zinzow, Ph.D.

864-656-4376hzinzow@clemson.edu

Lauren Smalls, B.S.

864-656-3210ltsmall@clemson.edu

Locations

Addiction Medicine Clinic, Prisma Health Upstate

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Leigh Huckins

864-643-8567Elizabeth.Huckins@Prismahealth.org

The Phoenix Center

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

Kimbley Smith

864-467-3790kimsmith@phoenixcenter.org

More Information

Sponsor

Clemson University

Last update posted

Sep 23, 2024

Last verified

Jun, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Clemson University on 2024-09-23.