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Набор по приглашению NCT07218159

Can the IDEA3 Intervention Prevent Intimate Partner Violence?: A Substudy to the IDEA3 Randomized Controlled Trial

Без фазы С лечением Intimate Partner Violence (IPV)

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: IDEA3 Sexual Assault Resistance Intervention, Consent workshop.
Кому может быть актуально
Состояния в реестре: Intimate Partner Violence (IPV). Базовые параметры: 17 лет — 26 лет · Все.
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, Канада
Следующий шаг
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Официальное название

Can an Evidence-based Sexual Assault Resistance Intervention Also Prevent Intimate Partner Violence (IPV)? A Randomized Controlled Trial Sub-Study of the Efficacy of IDEA3 for Reducing IPV in Undergraduate Women

Обзор

The goal of this study is to understand if the Internet-Delivered Enhanced Assess, Acknowledge, Act (IDEA3) sexual assault resistance program works to prevent intimate partner violence in undergraduate women. Participants who were in a prior trial by the study team (the IDEA3 parent trial) and joined in September 2024 or later will be invited to also join this study at the conclusion of the parent study. Participants in this study will fill out one additional survey. Researchers will compare intimate partner violence victimization between the control group and the intervention group.

Подробное описание

About 1 in 4 undergraduate women experience intimate partner violence (IPV) before graduation, and 1 in 5 women experience sexual assault (SA). IPV and SA are linked to academic or professional consequences for women who are victimized in college, including decreased class attendance, difficulty concentrating on schoolwork, withdrawing from classes, and dropping out of higher education entirely. The Enhanced Assess, Acknowledge, Act (EAAA) program is the only intervention proven to reduce the one-year incidence of campus SA in a randomized controlled trial (RCT) by 50%. A trial sub-study showed that EAAA also reduced IPV victimization by over 50%. EAAA is a theory-based 12-hour group intervention that increases women's abilities to assess a situation (cognitive appraisal to recognize empirically supported "red flags"), quickly acknowledge the potential for assault (e.g., overcoming self-doubt that one may be misreading the situation), and act to resist SA using evidence-based strategies. However, uptake of this effective in-person program has been limited by the cost and burden for college campuses to implement the program themselves. The researchers are currently testing an online adaptation of EAAA known as Internet-Delivered EAAA (IDEA3) in a Canadian-funded RCT, to evaluate a version of EAAA that will be more feasible to implement widely. An online format would lower costs and allow a central non-profit to deliver the program nationwide, with students from any campus participating via Zoom. While the trial was designed to evaluate the effect of IDEA3 on SA, the researchers will add an IPV sub-study to the trial. This sub-study will determine the efficacy of IDEA3 in reducing the one-year incidence of IPV, as compared to a consent workshop control condition, in US undergraduate women. The results of the study will provide key data that can be used to scale an evidence-based solution to this critical and timely issue.

This is an add-on sub-study to NCT06058455. Participants recruited in September 2024 and later into NCT06058455 will be invited to participate in this sub-study at their 12-month survey. Participants will be invited to fill out a survey on experiences of intimate partner violence (IPV) over the prior 12 months. This sub-study will enable us to determine the efficacy of IDEA3 in reducing the one-year incidence of IPV, as compared to a consent workshop control condition, in undergraduate women.

Вмешательства

  • Поведенческое IDEA3 Sexual Assault Resistance Intervention
    Internet-delivered EAAA (IDEA3), adapted from an in-person sexual assault resistance education intervention: Enhanced Assess, Acknowledge, Act (EAAA) intervention that was found in a randomized trial to reduce sexual assault victimization by about 50% at follow-up. IDEA3 designed for female identifying university students and focuses on resisting sexual assault committed by males in 4, 3-hour units: 1-ASSESS builds ability to detect risk with male acquaintances and develop risk reduction strateg
  • Поведенческое Consent workshop
    Participant pairs assigned to the control arm will receive a 60-minute session consisting of a 60-min interactive, virtual consent workshop. The workshop will include information on a) what consent is, including the idea that consent is about bodily autonomy and applies to interactions beyond sex, b) how to give and ask for consent, and c) examples of what it looks like to ask for and give/not give consent. This presentation will be given by a well-trained Research Assistant.

Первичные конечные точки

  • Physical and psychological intimate partner violence [Срок оценки: 12 months]

Критерии участия

Inclusion Criteria: Enrolled in the IDEA3 parent study in September 2024 or later and completed the 12 month survey for the parent trial

Original inclusion criteria for the parent trial:

  • 1st- and 2nd-year university students at one of the 4 sites
  • female-identifying students
  • students between ages of 17-24 at the time of enrollment into the parent trial
  • able to attend one of the scheduled program groups
  • able and willing to be matched with another eligible student

Критерии исключения

  • None

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
Профилактика

Центры проведения

США · 3 центра
  • University of Central Florida — Orlando
  • University of Maryland — College Park
  • University of Michigan — Ann Arbor
Канада · 2 центра
  • University of Guelph — Guelph
  • University of Windsor — Windsor

Идентификаторы

NCT: NCT07218159 · REB# 23-063

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗