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临床试验/NCT07547631
NCT07547631
尚未招募
不适用

Enlace Familiar Mental Health Intervention

University of Michigan1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2026年7月1日最近更新:
适应症Mental Health
干预措施Enlace Familiar

概览

阶段
不适用
状态
尚未招募
入组人数
64
试验地点
1
主要终点
Frequency of youth reported communication about mental health

概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Enlace Familiar

Experimental

32 participants

干预措施: Enlace Familiar (Behavioral)

Standard care

No Intervention

32 participants

结局指标

主要结局

Frequency of youth reported communication about mental health

时间窗: Up to 6 months

Measured 3 times on a Likert type scale effect of Enlace Familiar on youth (i.e., none, 1-3 times, 3-5 times, more than 5 times).

次要结局

  • Proportion of participants reporting moderate or greater satisfaction with the overall intervention(6 months)
  • Proportion of participants reporting moderate or greater satisfaction with Community Health Workers (CHWs) delivering the intervention(6 months)
  • Retention as measured by the percent of enrolled participants who completed the 8-week follow up(6 months)
  • Adherence as measured by the percent of participant who attended both CHW-led sessions(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernanda Cross

Assistant Professor of Social Work

University of Michigan

研究点 (1)

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