NCT06570720

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress91%
Oct 2024Jun 2026

First Submitted

Initial submission to the registry

August 14, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 18, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

August 14, 2024

Last Update Submit

February 14, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Perceived helpfulness

    Participants will rate the helpfulness of information provided. Range: 1 to 5. Higher scores represent greater helpfulness.

    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.

    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.

    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.

    Baseline; 1-, 3-, and 6-month follow-up

Study Arms (2)

ASSIST

EXPERIMENTAL

Participants in this arm will receive online survey assessments as well as the behavioral intervention, ASSIST.

Behavioral: Alcohol-focused Support of Survivors in Sororities Training (ASSIST)

Assessment-Only

NO INTERVENTION

Participants in this arm will only receive online survey assessments.

Interventions

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.

ASSIST

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipant eligibility is based on sorority membership
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Greek organization of undergraduate women recognized by the Office of Fraternity \& Sorority Life with a physical house for chapter members
  • At least 80 active members
  • Aged 18 years or older
  • Current student
  • Active member in a participating sorority chapter

You may not qualify if:

  • \[None\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking in College

Interventions

EthanolInsemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

Alcohol DrinkingDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsInsemination, ArtificialReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative TechniquesInseminationReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Anna Jaffe

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Jaffe, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 26, 2024

Study Start

October 18, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations