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
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.
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.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 60 is close to the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Clemson University is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
Compared within Opioid-Related Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Substance-Related Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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Exclusion Criteria:
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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)
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).
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
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).
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).
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).
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).
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).
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).
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).
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).
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).
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