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Идёт набор NCT06309134

The Healthy Families Bright Futures Program

Без фазы С лечением Alcohol Drinking Violence in Adolescence

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: Healthy Families Bright Futures Program.
Кому может быть актуально
Состояния в реестре: Alcohol Drinking, Violence in Adolescence. Базовые параметры: 15 лет — 18 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
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

An Online Family-based Program to Prevent Alcohol Use and Dating and Sexual Violence Among Sexual and Gender Minority Youth

Обзор

The goal of this clinical trial is to learn about an online group program (Healthy Families Bright Futures program) for LGBTQ+ teens and their caregivers. The main question\[s\] it aims to answer are: • is this program acceptable, appropriate, and feasible for LGBTQ+ youth and their caregivers • does the program affect teen (alcohol use, dating violence, alcohol use refusal self-efficacy, healthy communication self-efficacy) and caregiver (accepting behaviors, parenting self-efficacy, parenting behaviors) outcomes associated with risk for dating violence and alcohol use among LGBTQ+ teens. Participants will participate in a one-hour weekly online group for seven weeks with separate groups for teens and caregivers.

Подробное описание

Research documents concerning rates of alcohol use (AU) and dating violence (DV) among sexual and gender minority youth (SGMY), likely related to a combination of population-specific risk factors (e.g., caregiver rejection, internalized homo/bi/transphobia), universal risk factors (e.g., deficits in social emotional skills and alcohol refusal skills, inaccurate perceptions of alcohol norms) and lack of protective factors (e.g., parenting and family relational skills). To date, however, little is known about how to concurrently prevent AU and DV among SGMY. This study will develop and evaluate an online family-based program (Healthy Families Bright Future program \[HFBFP\]) to prevent AU and DV among SGMY ages 15 to 18. The HFBFP is a group-based intervention that includes seven weekly separate caregiver and youth sessions. Programming for caregivers focuses on fostering acceptance and support for SGMY and enhancing relevant caregiving/positive parenting skills. Programming for SGMY focuses on reducing internalized homo/bi/transphobia and enhancing social-emotional skills, increasing accurate perceptions of alcohol and dating violence norms, increasing alcohol refusal skills, and improving conflict resolution strategies/improving assertive communication. SGMY and caregiver programming is designed to be complementary in content to enhance the potency of programming components, and program skills will be practiced as a family between sessions. The program is co-facilitated by an SGM young adult and SGMY caregiver. During the Pilot Evaluation Phase, the investigators will via a randomized controlled trial of caregiver-SGMY dyads (40 dyads assigned to the HFBFP and 40 dyads to a waitlist), assess the acceptability, appropriateness, and feasibility of the HFBFP via program observations, post-session surveys (n = 80), and exit interviews (n = 28) with participants. The study will test the HFBFP's efficacy in improving relevant family/caregiver outcomes (e.g., family communication skills, parenting self-efficacy, affirming behaviors) as well as relevant SGMY outcomes (e.g., alcohol use intentions, alcohol use, dating violence victimization and perpetration, minority stress, perceived DV/alcohol use norms, communication self-efficacy) via surveys completed at baseline, immediate post-test, and 3-month follow-up. Participants will be recruited from across the U.S. via social media and from LGBTQ+ organizations.

Вмешательства

  • Поведенческое Healthy Families Bright Futures Program
    Seven weekly online group sessions with separate sessions for teens and caregivers. Sessions focus on increasing knowledge and acceptance of LGBTQ+ identities, alcohol use and dating violence social norms correction, bystander intervention, assertive communication skills, social emotional skills, family problem solving, and parenting behaviors.

Первичные конечные точки

  • Measure of Adolescent Relationships and Harassment and Abuse - Victimization [Срок оценки: Baseline, 8 weeks, 3 months]
  • Measure of Adolescent Relationships and Harassment and Abuse - Perpetration [Срок оценки: Baseline, 8 weeks, 3 months]
  • Monitoring the future alcohol use intentions [Срок оценки: Baseline, 8 weeks, 3 months]
  • Monitoring the future alcohol use items [Срок оценки: Baseline, 8 weeks, 3 months]
  • Drinking Refusal Self-Efficacy Questionnaire- Shortened adolescent version [Срок оценки: Baseline, 8 weeks, 3 months]
  • Conflict Tactics Scale- 2 (SGM Specific IPV Perpetration) [Срок оценки: Baseline, 8 weeks, 3 months]
  • Conflict Tactics Scale- 2 (SGM Specific IPV Victimization) [Срок оценки: Baseline, 8 weeks, 3 months]
  • Program acceptability, appropriateness, and feasibility ratings (drawn from Weiner) [Срок оценки: 8 weeks]
Вторичные конечные точки (12)
  • PHQ-8 (modified for adolescents) [Срок оценки: Baseline, 8 weeks, 3 months]
  • LGBTQ+ teen perceived drinking norms [Срок оценки: Baseline, 8 weeks, 3 months]
  • LGBTQ+ teen perceived dating violence norms [Срок оценки: Baseline, 8 weeks, 3 months]
  • Sexual communication self-efficacy scale [Срок оценки: Baseline, 8 weeks, 3 months]
  • Communication skills test (modified to assess self-efficacy) [Срок оценки: Baseline, 8 weeks, 3 months]
  • Short Internalized Homonegativity Scale. [Срок оценки: Baseline, 8 weeks, 3 months]
  • Self-Efficacy for Parenting Adolescents Scale [Срок оценки: Baseline, 8 weeks, 3 months]
  • Parental Monitoring Short Scale [Срок оценки: Baseline, 8 weeks, 3 months]
  • Parent Adolescent Communication Scale [Срок оценки: Baseline, 8 weeks, 3 months]
  • Alabama Parenting Questionnaire- Short form [Срок оценки: Baseline, 8 weeks, 3 months]
  • Social and Emotional Competencies Questionnaire [Срок оценки: Baseline, 8 weeks, 3 months]
  • LGBTQ+ Microaggressions and Microaffirmations in Families [Срок оценки: Baseline, 8 weeks, 3 months]

Критерии участия

Критерии включения

  • Age between 15 and 18 years
  • Self-identify as a sexual and/or gender minority or questioning identity
  • In dating/sexual/hook up relationship in past three months
  • Ability to read, write, and speak English
  • Current residence in United States
  • Regular Internet access
  • Ability to complete program and assessments
  • Has caregiver willing to complete program who is eligible to participate (18 +, sees teen at least once per week, can read/write/speak English, residence in US, Internet access, no current suicidality, psychotic symptoms, or symptoms of serious mental illness)

Критерии исключения

  • Current enrollment as a college student
  • Current suicidality
  • Current psychotic symptoms
  • Current symptoms of serious mental illness

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 of Colorado Colorado Springs — Colorado Springs

Идентификаторы

NCT: NCT06309134 · R34AA030662

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗