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Clinical Trials/NCT06608979
NCT06608979
Recruiting
Not Applicable

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

Clemson University2 sites in 1 country60 target enrollmentJune 11, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use Disorders
Sponsor
Clemson University
Enrollment
60
Locations
2
Primary Endpoint
ARC3 Consent Scale
Status
Recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 11, 2024
End Date
March 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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).

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)

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

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).

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).

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)

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).

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.

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).

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).

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).

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).

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).

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.

Secondary Outcomes

  • 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 Sites (2)

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