Clinical trial NCT06608979: Trauma Screening/Referral and Interpersonal Violence Prevention for Women with Substance Use Disorders
Official title: Trauma Screening/Referral and Interpersonal Violence Prevention for Women with Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Clemson University
Sponsor class: OTHER
Collaborators: name: Prisma Health-Upstate
First posted: 2024-09-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm design with baseline, posttest, and follow-up assessments
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

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Exclusion Criteria:

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

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Primary outcomes:
measure: ARC3 Consent Scale
timeFrame: Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
measure: Illinois Rape Myth Acceptance Scale-Short Form
timeFrame: Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).f
measure: Attitudes Towards Dating Violence
timeFrame: Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
measure: Dating Behavior Survey
timeFrame: Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
measure: Coping Responses to Sexual Aggression
timeFrame: Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
measure: Barriers to Resistance
timeFrame: Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
measure: Knowledge and Use of Resources
timeFrame: 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:
measure: Sexual Experiences Survey Short Form Victimization
timeFrame: Participants complete this measure at baseline, 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
measure: PC-PTSD-5
timeFrame: Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
measure: PHQ-2 (Depression)
timeFrame: Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
measure: CAGE-AID (Substance Use)
timeFrame: Participants complete this measure at baseline, post intervention (2 weeks), 1 month follow-up (6 weeks), and 3 month follow-up (18 weeks).
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Addiction Medicine Clinic, Prisma Health Upstate
state: South Carolina
city: Greenville
country: United States
facility: The Phoenix Center
state: South Carolina
Study officials:
affiliation: Clemson University
name: Heidi Zinzow, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: