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RecruitingNCT06608979Updated Sep 23, 2024

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

An interventional study of Screening/Referral and Prevention in Substance Use Disorders, Posttraumatic Stress Disorder and Opioid Use Disorder, sponsored by Clemson University. Recruiting at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-23.

Sponsored by Clemson University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

-

Exclusion Criteria:

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

-

04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study 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.

    Behavioral: Screening/Referral and Prevention

Interventions

  • BehavioralScreening/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)

05

What researchers measure

Primary outcomes

  1. 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)

    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).

  2. 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).

    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

  3. 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)

    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).

  4. 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.

    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).

  5. 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).

    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).

  6. 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).

    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).

  7. 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.

    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).

Secondary outcomes

  1. 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)

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

  2. 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.

    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).

  3. 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.

    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).

  4. 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.

    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).

06

Study locations

2 of 2 sites recruiting
  • Addiction Medicine Clinic, Prisma Health Upstate
    Greenville, South Carolina 29605, United States
    Recruiting
  • The Phoenix Center
    Greenville, South Carolina 29607, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT06608979
Lead sponsor
Clemson University
Collaborators
Prisma Health-Upstate
Responsible party
Sponsor
First posted
Sep 23, 2024
Start date
Jun 11, 2024
Primary completion
Mar 2025 (estimated)
Completion
Mar 2025 (estimated)
Last update
Sep 23, 2024

Study contacts

Heidi Zinzow, Ph.D.
Contact
hzinzow@clemson.edu
864-656-4376
Lauren Smalls, B.S.
Contact
ltsmall@clemson.edu
864-656-3210
Heidi Zinzow, Ph.D.
principal investigator · Clemson University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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