PAIRS: Friend-Based AISA Intervention
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: Friend-Based Motivational Interview, Treatment as usual (TAU).
- Кому может быть актуально
- Состояния в реестре: Sexual Violence, College Drinking, Behavioral Changes. 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
Friend-based Intervention to Reduce Alcohol-Involved Sexual Assault Risk
Обзор
This Phase 2 trial will to examine the efficacy of a brief dyad-based motivational interview (PAIRS MI) delivered to friend dyads with an active treatment-as-usual condition, and a 1-year follow-up.
Подробное описание
In this project the investigators will conduct a Phase 2 trial to test the efficacy of a friend-based motivational interview (FMI) compared to a treatment-as-usual (TAU) control, following participants over 1-year post-intervention (Aim 1.). With this trial the investigators also will address some key questions about FMI effects on target attitudes and behaviors (Aim 2.a.) that may be mechanisms of intervention outcome (Aim 2.b.). This includes Instrumental mechanisms (readiness, barriers, and assault protective behavior skills), and the dyadic relationship (closeness, collaboration between the friends in the dyad).
Aim 1. In a Phase 2 trial, the investigators will examine the efficacy of a friend-based motivational intervention (FMI) to reduce AISA risk relative to an active control condition over 1-year post-intervention.
The investigators will compare the FMI to a standard sexual assault prevention intervention widely used on U.S. college campuses. The investigators will use a three-level HLM, with repeated measures over one year (3, 6, 9, 12-month follow-up) nested within person (Level 2), and person nested within dyad (Level 3) to examine AISA outcomes. The investigators expect those in the FMI to report fewer incidences of AISA at follow-up assessments. Both AISA and assaults not involving alcohol will be examined.
Aim 2. Examine mechanisms (instrumental, relationship) of intervention effects. In this dyad-based FMI, an interdependent process may unfold that influences outcomes whereby the FMI influences AISA risk through a person's own change, as well as through their friend's change. It is important to distinguish these two processes as each may be an important part of intervention effects. Accordingly, with longitudinal Actor-Partner Interdependence Models (APIM, Cook \& Kenny, 2005; Kenny \& Ledermann, 2017) the investigators will test whether the intervention impacts mechanisms of change through actor (a person's own change), partner (friend's change) effects, or both (Aims 2a-2c).
Aim 2.a. Examine intervention effects on instrumental and relationships putative mediators, whether the putative predictors predict AISA.
In this aim the investigators will test pathways relevant to the proposed mediational pathways (intervention to mediator, and mediator to outcome).
Aim 2.b. Formally test actor (person's own change) mechanisms (indirect effects). Indirect effects through instrumental (readiness, FAPB skills, and perceived barriers) and relationship (closeness and collaboration) mechanisms will be tested. The investigators expect that the FMI will predict increases in closeness, collaboration, readiness, and FAPB skills, and decreases in perceived barriers, which in turn, will predict declines in AISA.
Aim 2.c. Formally test partner (friend's change) mechanisms (indirect effects). Indirect effects through friend's instrumental (readiness, FAPB skills, and perceived barriers) and relationship (closeness and collaboration) mechanisms will be tested. Because partner effects have not previously been examined, tests of partner effects are viewed as exploratory and no specific hypotheses are offered.
This Phase 2 trial will help to establish the efficacy of an intervention that harnesses the power of friends to address the significant public health problem of campus-based AISA. This study also will shed needed light on the mechanisms and complex nature of dyadic change that occurs in response to such an intervention. Findings will lay the groundwork for Phase 3 work.
Вмешательства
- Поведенческое Friend-Based Motivational Interview
The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to - Поведенческое Treatment as usual (TAU)
This 65-minute single-session stand-alone course is a supplemental component of the EverFi (Vector Solutions) Sexual Assault Prevention for Undergraduate Students prevention suite that is administered in an online didactic format. All participants (intervention and control) will have completed the basic course of the Sexual Assault Prevention for Undergraduate Students at matriculation, per university requirements. For the current study, the supplemental Healthy Relationships component will be a
Первичные конечные точки
- Alcohol-Involved Sexual Assault [Срок оценки: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up]
- Change in Drinking [Срок оценки: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up]
Вторичные конечные точки (6)
- Change in Readiness to Intervene [Срок оценки: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up]
- Change in Peer-Directed Bystander Behaviors Scale for Strangers [Срок оценки: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up]
- Changes to Assault Protective Strategies [Срок оценки: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up]
- Change to Barriers to Sexual Assault Bystander Intervention [Срок оценки: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up]
- Change to Concerns About Intervening [Срок оценки: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up]
- Change to Bystander Intervention Behavior [Срок оценки: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up]
Критерии участия
Критерии включения
- Women
- 4 or more drinks in a single sitting 2 or more times monthly in the past 3 months
- does not live at home with parents
- reports going out (not necessarily drinking) with the other member of their dyad > 1/week
Критерии исключения
- Can not speak and understand English sufficiently
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 · 1 центр
- University at Buffalo Department of Psychology — Buffalo
Идентификаторы
NCT: NCT07433270 · 00009969