Alcohol Drinking in CollegeNCT06570720
Alcohol-focused Support of Survivors in Sororities Training (ASSIST) - Pilot
A study testing Alcohol-focused Support of Survivors in Sororities Training (ASSIST) in people with Alcohol Drinking in College, run by University of Washington at 1 site in United States.
Trial summary
The goal of this clinical trial is to conduct a preliminary evaluation of the ASSIST (Alcohol-focused Support of Survivors in Sororities Training) intervention in sorority chapters. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking in College
- What is being tested?
- Alcohol-focused Support of Survivors in Sororities Training (ASSIST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- [None]
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Anna E Jaffe, PhD, 2062210355, ajaffe2@uw.edu
About this study
Official title: ASSIST Study: Pilot Cluster Randomized Trial
The goal of this clinical trial is to conduct a preliminary evaluation of the ASSIST (Alcohol-focused Support of Survivors in Sororities Training) intervention in sorority chapters. ASSIST is a newly developed web-based intervention to increase peer support of sexual assault survivors and reduce encouragement of drinking to cope within social networks of sororities. To test whether the intervention is feasible and shows preliminary signs of working, a pilot cluster randomized trial will be conducted. Sorority chapters will be recruited and randomly assigned to an intervention condition or an assessment-only condition. Individuals within each sorority will be recruited and complete a norm documentation survey. One month later, participants will complete a baseline survey, and if assigned to the intervention condition, will then receive the web-based ASSIST intervention, which will include normative feedback on values and drinking, psychoeducation about sexual assault recovery and the role of alcohol, and skills training in behaviors that can be used to support survivors without or while moderating heavy drinking. All participants will complete online follow-up surveys at 1-, 3-, and 6-months post-intervention.
- Conditions
- Alcohol Drinking in College
- Being tested
- Alcohol-focused Support of Survivors in Sororities Training (ASSIST)
- Medical subject headings
- Alcohol Drinking in College
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol-focused Support of Survivors in Sororities Training (ASSIST)Behavioural
A web-based intervention that includes sorority and individual values, personalized normative feedback (adapted to address sexual assault, support, and acceptability of encouraging peer drinking), psychoeducation on sexual assault and alcohol, and skills training in behaviors to support sexual assault survivors without heavy drinking.
| Study group | Role | What they receive |
|---|---|---|
| ASSIST | Experimental | Participants in this arm will receive online survey assessments as well as the behavioral intervention, ASSIST. Receives: Behavioral: Alcohol-focused Support of Survivors in Sororities Training (ASSIST) |
| Assessment-Only | No intervention | Participants in this arm will only receive online survey assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived helpfulness
Participants will rate the helpfulness of information provided. Range: 1 to 5. Higher scores represent greater helpfulness.
Measured: Immediate post-intervention
Social Support
On the Multidimensional Scale of Perceived Social Support (MSPSS), participants will rate the support of family, friends, and a significant other. A mean score will be computed. Range: 1 to 7. Higher scores represent more social support.
Measured: Baseline; 1-, 3-, and 6-month follow-up
Alcohol use
On the Daily Drinking Questionnaire (DDQ), participants will report how many standard drinks (0 to 25+) they consumed each day for a typical week in the past month. Total number of drinks per week will be calculated. Range: 0 to 175. Higher scores represent more alcohol use.
Measured: Baseline; 1-, 3-, and 6-month follow-up
Alcohol-related consequences
On the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ), participants will indicate whether they have experienced each of 24 negative consequences of alcohol use in the past month. A count of number of consequences experienced will be calculated. Range: 0-24. Higher scores represent more consequences experienced.
Measured: Baseline; 1-, 3-, and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start18 Oct 2024
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Drinking in CollegeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Anna Jaffe, University of Washington
- Investigators
- Anna Jaffe, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570720
- Sponsor's protocol ID
- STUDY00018662
- Other IDs
- K08AA028546
- Status last verified
- Feb 2025
- First submitted
- 14 Aug 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSIST Study: Pilot Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06570720
- Acronym / sponsor ID
- STUDY00018662
- Conditions
- Alcohol Drinking in College
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to conduct a preliminary evaluation of the ASSIST (Alcohol-focused Support of Survivors in Sororities Training) intervention in sorority chapters. ASSIST is a newly developed web-based intervention to increase peer support of sexual assault survivors and reduce encouragement of drinking to cope within social networks of sororities. To test whether the intervention is feasible and shows preliminary signs of working, a pilot cluster randomized trial will be conducted. Sorority chapters will be recruited and randomly assigned to an intervention condition or an assessment-only condition. Individuals within each sorority will be recruited and complete a norm documentation survey. One month later, participants will complete a baseline survey, and if assigned to the intervention condition, will then receive the web-based ASSIST intervention, which will include normative feedback on values and drinking, psychoeducation about sexual assault recovery and the role of alcohol, and skills training in behaviors that can be used to support survivors without or while moderating heavy drinking. All participants will complete online follow-up surveys at 1-, 3-, and 6-months post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASSIST | Experimental | Behavioral: Alcohol-focused Support of Survivors in Sororities Training (ASSIST)Participants in this arm will receive online survey assessments as well as the behavioral intervention, ASSIST. |
| Assessment-Only | No intervention | –Participants in this arm will only receive online survey assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- [None]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol-focused Support of Survivors in Sororities Training (ASSIST)A web-based intervention that includes sorority and individual values, personalized normative feedback (adapted to address sexual assault, support, and acceptability of encouraging peer drinking), psychoeducation on sexual assault and alcohol, and skills training in behaviors to support sexual assault survivors without heavy drinking. | Behavioural | ASSIST |
Primary outcome
Perceived helpfulness
Time frame: Immediate post-intervention
Participants will rate the helpfulness of information provided. Range: 1 to 5. Higher scores represent greater helpfulness.
Social Support
Time frame: Baseline; 1-, 3-, and 6-month follow-up
On the Multidimensional Scale of Perceived Social Support (MSPSS), participants will rate the support of family, friends, and a significant other. A mean score will be computed. Range: 1 to 7. Higher scores represent more social support.
Alcohol use
Time frame: Baseline; 1-, 3-, and 6-month follow-up
On the Daily Drinking Questionnaire (DDQ), participants will report how many standard drinks (0 to 25+) they consumed each day for a typical week in the past month. Total number of drinks per week will be calculated. Range: 0 to 175. Higher scores represent more alcohol use.
Alcohol-related consequences
Time frame: Baseline; 1-, 3-, and 6-month follow-up
On the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ), participants will indicate whether they have experienced each of 24 negative consequences of alcohol use in the past month. A count of number of consequences experienced will be calculated. Range: 0-24. Higher scores represent more consequences experienced.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Jaffe principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol-focused Support of Survivors in Sororities Training (ASSIST) in people with Alcohol Drinking in College, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Jaffe, PhD (206-221-6692, ajaffe2@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived helpfulness (time frame: Immediate post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.