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Набор скоро начнётся NCT07547631

Enlace Familiar: Supporting the Mental Health of Latino Adolescents

Без фазы С лечением Mental Health

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: Enlace Familiar.
Кому может быть актуально
Состояния в реестре: Mental Health. Базовые параметры: 14 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
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Официальное название

Enlace Familiar Mental Health Intervention

Обзор

The goal of this clinical trial is to pilot and evaluate Enlace Familiar, a culturally responsive intervention designed to support Latino adolescents in discussing their mental health needs with caregivers or other trusted adults. The study will examine the feasibility and acceptability of the intervention and examine its potential impact on mental health communication among Latino adolescents ages 14-18 experiencing mental health concerns. Participants will be randomized into two groups, with 32 adolescents assigned to the Enlace Familiar intervention and 32 adolescents assigned to a control condition. The intervention will be implemented in partnership with community health workers (CHWs), who will serve as culturally relevant facilitators. The main questions this study aims to answer are: 1. Is Enlace Familiar feasible and acceptable for Latino adolescents when delivered by CHWs? 2. Does participation in Enlace Familiar improve adolescents' discussions of mental health needs with caregivers or other trusted adults? Participants will: * Complete baseline assessments related to mental health communication, attitudes toward mental health, mental health literacy, and engagement in mental health services. * Participate in the Enlace Familiar intervention, delivered by trained CHWs. * Complete follow-up assessments to evaluate changes in primary and secondary outcomes. * Participate in qualitative interviews or feedback activities to provide information about the acceptability and perceived usefulness of the intervention. Researchers will use a mixed methods design to evaluate intervention feasibility and acceptability and to explore preliminary changes in adolescent mental health communication following participation in the intervention.

Вмешательства

  • Поведенческое Enlace Familiar
    Enlace Familiar will consist of two individual encounters, in person or virtual. Youth will also receive a list of mental health community resources, including school-based, online, and apps-based support.

Первичные конечные точки

  • Frequency of youth reported communication about mental health [Срок оценки: Up to 6 months]
Вторичные конечные точки (4)
  • Proportion of participants reporting moderate or greater satisfaction with the overall intervention [Срок оценки: 6 months]
  • Proportion of participants reporting moderate or greater satisfaction with Community Health Workers (CHWs) delivering the intervention [Срок оценки: 6 months]
  • Retention as measured by the percent of enrolled participants who completed the 8-week follow up [Срок оценки: 6 months]
  • Adherence as measured by the percent of participant who attended both CHW-led sessions [Срок оценки: 6 months]

Критерии участия

Our inclusion criteria for youth participation include:

  • High school-age adolescents, ages 14-18 who self-identify as Latino
  • Adolescents scoring between 3-12 on the Patient Health Questionnaire-4 (PHQ-4), a brief mental health screening tool for anxiety and depression
  • Adolescents who are not currently receiving mental health treatment or in the past 12 months
  • Adolescents fluent in Spanish or English

Our inclusion criteria for parent participation include:

  • Parents of High school-age adolescents, ages 14-18 who completed the intervention (T3)
  • Parents fluent in Spanish or English

Our inclusion criteria for Community Health Worker participation include:

● CHW who implemented our intervention

Our Exclusion Criteria: for youth participation include:

  • youth not fluent in English or Spanish
  • youth currently receiving mental health treatment or who have received it in the past year

Our exclusion criteria for parent include:

  • parents of High school-age adolescents, ages 14-18 who did not completed the intervention (T3);
  • parents not fluent in Spanish or English

Our exclusion criteria for Community Health Worker participation include

● CHWs not involved in our intervention.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT07547631 · HUM00282928 · 1K01MD019325-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗