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Набор скоро начнётся NCT07726004

Development of an Alcohol, Cannabis, and Sexual Assault Risk Reduction Program for High Risk College Women

Без фазы С лечением Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program With Alcohol and Cannabis Content

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program, Assessment Only Control.
Кому может быть актуально
Состояния в реестре: Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program With Alcohol and Cannabis Content. Базовые параметры: 18 лет — 24 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Development of an Alcohol, Cannabis, and Sexual Assault Risk Reduction Program for High Risk College Women, Pilot RCT

Обзор

The goal of this clinical trial is to assess the feasibility of the Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program with alcohol and cannabis content (EAAA+) in undergraduate college women between ages 18-24 years old who use alcohol and cannabis. The main objectives it aims to answer are: * To determine the feasibility of a randomized controlled trial comparing EAAA+ to an assessment only control condition. * To determine if EAAA+ will result in larger decreases in HED and cannabis use, more accurate perceptions of alcohol and cannabis norms, and greater increases in PBS at follow up. * To determine if EAAA+ will result in (1) greater increases in SA risk perception and use of assertive SA resistance strategies and (2) decreased barriers to SA resistance while using alcohol and cannabis, and (3) greater reductions in incapacitated SA. Researchers will compare participants who received EAAA+ to an assessment only condition to test the objectives stated above. Participants will: * Sign an informed consent form and complete a survey. Once the survey is completed, they will be randomly assigned to complete the sexual assault education program or not. * Participants assigned to the sexual assault education program will complete two in-person sessions (about 7 hours each) or four in-person sessions (about 3.5 hours each) and will also complete an online module in between modules 2 and 3 as part of the education program and complete four short surveys. * Complete 4 weeks of assessments and complete a follow-up survey at 1, 3, and 6 months after the initial session.

Вмешательства

  • Поведенческое Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program
    Participants will be randomized to EAAA+, a combined program for alcohol and cannabis prevention and sexual assault risk reduction.
  • Поведенческое Assessment Only Control
    Participants will be randomized to an assessment only control.

Первичные конечные точки

  • Cannabis Use Frequency Measured at Follow-Ups [Срок оценки: Up to 1-month, 3-months, and 6-months post intervention]
  • Heavy Episodic Drinking Frequency Measured at Follow-Ups [Срок оценки: Up to 1-month, 3-months, and 6-months post intervention]
  • Attempted Sexual Assault Measured at Follow-Ups [Срок оценки: Up to 1-month, 3-months, and 6-months post intervention]
  • Completed Sexual Assault Measured at Follow-Ups [Срок оценки: Up to 1-month, 3-months, and 6-months post intervention]

Критерии участия

Критерии включения

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study determined at pre-screening
  • Between the ages of 18-24 years old determined at pre-screening
  • Identifies as a woman determined at pre-screening
  • Is currently enrolled as an undergraduate in Colorado with a valid student email address determined at pre-screening
  • Engaged in heavy episodic drinking (i.e., 4+ drinks within a two-hour period) at least once in the past month with an intention to drink in the future determined at pre-screening
  • Engaged in using cannabis at least once in the past month with an intention to use in the future determined at pre-screening
  • Is available to attend sessions on specific dates
  • Has a phone they can complete web-based surveys on determined at pre-screening

Критерии исключения

1\. There are no exclusion criteria aside from not meeting inclusion criteria.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • University of Colorado Anschutz Medical Campus — Aurora

Идентификаторы

NCT: NCT07726004 · 24-2079 · K01AA028844

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗