Testing STAR and TextSTAR: A Randomized Controlled Trial
5 other identifiers
interventional
394
1 country
3
Brief Summary
The goal of this clinical trial is to learn whether a video given for recent sexual assault survivors and/or a 3-week text messaging intervention with similar content is effective at reducing mental health problems and substance misuse following the assault.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
June 9, 2026
February 1, 2026
3 years
June 1, 2026
June 8, 2026
Conditions
Outcome Measures
Primary Outcomes (9)
Opioid misuse
Assessed using Tobacco, Alcohol, Prescription Medication, and Other Substance (TAPS) Tool-part 1. The TAPS tool is a brief, two-part assessment of substance use and misuse. The TAPS-1 is a screener with 4 items assessing frequency of use of tobacco, alcohol, prescription medication, and illicit substances on a scale from 0 = never to 4 = daily/almost daily. Any response other than "never" on the TAPS-1 indicates a positive screen, which is used in conjunction with the PCL-5 to determine responder status for randomization to the text program.
1 week
Change in acute stress/ posttraumatic stress
Assessed with PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Scores range from 0-80, with scores of 31 or higher indicating probable PTSD.
1 week, 1 month, 3 months, 6 months
Change in Tobacco, Alcohol, and Other Drug Use Frequency
Assessed using the Timeline Followback (TLFB) Method The Timeline Followback Method (TLFB) is a widely used tool for assessing substance use (alcohol, drugs, cigarettes) that requires individuals to retrospectively report daily use of each type of substance on a calendar. For alcohol, participants are shown a standard drinks graphic and then asked to report how many drinks they consumed each day on a calendar and how many hours they drank on that day. For other substances, they are asked to report how many times they used.
1 week, 1 month, 3 months, 6 months
Substance use severity
Assessed with Alcohol, Smoking and Substance Involvement Screening Test (ASSIST; lifetime @ baseline). The ASSIST is an 8-item questionnaire. Item 1 maps lifetime use, while Items 2-8 measure frequency, dependence signs, and consequences of use. Responses for questions 2 through 8 are scored as follows: Never = 0; Once or twice = 1 or 2; Monthly = 2 to 4; Weekly = 3 to 5; and, Daily or almost daily: 4. Scores range from 0-39, where higher scores indicate greater severity of use.
baseline, 1 month, 3 months, 6 months
Depression symptoms
Assessed using the Patient Health Questionnaire-9 (PHQ-9) The PHQ-9 is an 9-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-27 where higher scores indicate more depressive symptoms.
1 month, 3 months, 6 months
Mindfulness skills usage
Assessed with 16 items from the Dialectical Behavior Therapy (DBT) skills subscale of the Ways of Coping Checklist, a 38 item self-report instrument that assesses DBT skills utilization in the past week on a scale from 0 = never used to 3 = used regularly. The checklist has excellent psychometric properties and has been shown to discriminate patients who received skills training during treatment from those who did not. Scores range from 0-48, where higher scores reflect greater skills utilization.
1 week, 1 month, 3 months, 6 months
Perceived control over recovery process
Assessed with the 8-item Perceived Present Control subscale of the Perceived Control Over Stressful Events Scale. Statements are rated on a Likert scale ranging from 1 (Very strongly disagree) to 4 (Very strongly agree), with a score range of 8-32, where higher averages indicate stronger perceived control. The scale has excellent psychometric properties and higher scores (which reflect greater perceived control) have been associated with recovery following sexual violence.
1 month, 3 months, 6 months
Pain severity
Assessed with the Brief Pain Inventory (BPI), a 4-item self-report measure that asks participants to rate their worst pain in the last week, their least pain in the last week, their pain on average, and their pain right now on a scale from 0 = no pain at all to 10 = pain as bad as you can imagine. An overall pain severity score is computed by taking the mean of the four items.
baseline, 1 week, 1 month, 3 months, 6 months
Opioid craving
Assessed with the 3-item Opioid Craving Scale which asks participants to rate how strong their desire to use opioids in the past 24-hours was (0 = no desire to use, 9 = extremely strong desire to use), how likely they would be to use if in the same environment when they used to use (0 = not at all likely, 9 = extremely likely), and how strong urges for opioids are when something reminds survivor of opioids (0 = no urge to use, 9 = extreme urge to use). Items are averaged for a total score (ranging from 0-9). Only those with any opioid use experience are asked these questions.
baseline, 1 week, 1 month, 3 months, 6 months
Secondary Outcomes (4)
Sexual violence stigma
1 month, 3 months, 6 months
Emotion dysregulation
1 month, 3 months, 6 months
Social support
1 month, 3 months, 6 months
Self-compassion
1 month, 3 months, 6 months
Study Arms (6)
Video, Above Threshold, Text
EXPERIMENTALParticipants in this condition will receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will be randomized to receive the textSTAR intervention.
Video, Above Threshold, No Text
EXPERIMENTALParticipants in this condition will receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will be randomized to not receive textSTAR.
Video, Below Threshold
EXPERIMENTALParticipants in this condition will receive the STAR intervention video and will be below threshold on PTSD and opioid misuse at 1 week and will not be randomized to receive further intervention.
No Video, Above Threshold, Text
EXPERIMENTALParticipants in this condition will not receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will be randomized to receive the textSTAR intervention.
No Video, Above Threshold, No Text
NO INTERVENTIONParticipants in this condition will not receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will not be randomized to receive the textSTAR intervention.
No Video, Below Threshold
NO INTERVENTIONParticipants in this condition will not receive the STAR intervention video and will be below threshold on PTSD and opioid misuse at 1 week and will not be randomized to receive further intervention.
Interventions
a 17-minute video that includes psychoeducation about ptsd and substance misuse plus tips to not avoid safe but scary situations, cope with distress and urges to use, and engage with social support to aid recovery
a 3-week daily text program that includes supportive/empowering messages along with brief coping tips to not avoid safe but scary situations, cope with distress and urges to use, and engage with social support to aid recovery
Eligibility Criteria
You may qualify if:
- or older
- Can read and respond to questions in English
- Are receiving a SAMFE exam for a assault/victimization within the previous week (7 days)
- Not currently or about to be hospitalized for severe injuries, suicidality, or psychosis
- Not currently or about to be incarcerated
You may not qualify if:
- Under age 18
- Those who cannot read and respond to questionnaires in English
- Those seeking care that does not include a SAMFE exam
- Those who cannot consent to receive SAMFE care
- Those who are currently or about to be hospitalized for severe injuries, suicidality, or psychosis
- Those who are currently or about to be incarcerated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Louisville Health
Louisville, Kentucky, 40202, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kate Walsh, PhD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2026
First Posted
June 5, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
June 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share