跳至主要内容
临床试验/NCT07378254
NCT07378254招募中不适用

Co-Producing a Trauma and Substance Use Mental Health Literacy Intervention

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年3月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Change in scores on the Multicomponent Mental Health Literacy Measure (MMHLM)

研究概览

简要总结

This study will build a partnership with a Community Advisory Board to co-produce, and then pilot test, a theory-guided mental health literacy intervention focused on trauma and substance use. Participants will take part in educational group sessions for 12 weeks and complete assessments at baseline and two follow-up time points (mid-intervention and post-intervention). Intervention participants will be randomly invited to post-study focus groups to gather feedback on their experiences in the program.

详细描述

This study will enhance mental health literacy (i.e., knowledge and beliefs related to mental health, including recognition, prevention, and management of symptoms) among a sample of young Black adults who have experienced lifetime trauma. The culturally tailored intervention will be guided by the Theory of Planned Behavior and social ecological model as guiding frameworks. Intervention components will be designed to promote behavioral, normative, and control beliefs related to mental health care utilization, with resources to target individual, interpersonal, organizational, and community levels of influence. Following development, the intervention will be piloted among young Black adults, utilizing a single-arm pilot design.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Self-identify as Black or African American
  • Be between the ages of 18 and 35 years old
  • Endorse previous lifetime trauma exposure
  • Participants must speak English
  • Participants are capable of giving informed consent and capable of complying with study procedures.

排除标准

  • 未提供

研究组 & 干预措施

FEELS

Experimental

Finding Emotional Empowerment and Lifelong Strength

干预措施: Finding Emotional Empowerment and Lifelong Strength (Behavioral)

结局指标

主要结局

Change in scores on the Multicomponent Mental Health Literacy Measure (MMHLM)

时间窗: 3-months

Assesses knowledge and beliefs about mental health disorders, including symptoms, causes, prevention and treatment strategies. Total scores range from 22 to 110, with higher scores indicating greater MHL.

Change in scores on the Short Attitudes Towards Mental Health Problems Scale (SATMHPS)

时间窗: 3-months

Measures personal, family, and community attitudes and stigma related to mental health challenges. Mean scores for subscales range from 0 to 3, with higher scores indicating more negative attitudes.

Change in scores on the Mental Help Seeking Intention Scale (MHSIS)

时间窗: 3-months

Measures intentions to seek help from a mental health professional in the event of a mental health concern. Mean scores range from from 1 to 7, with higher scores indicating stronger intentions.

Change in scores on the Self-Efficacy in Seeking Mental Health Care (SE-SMHC)

时间窗: 3-months

Assesses perceived ability to seek professional mental health care. Total scores range from 9 to 90, while subscale scores range from 5 to 50 (SE-KNOW) and 4 to 40 (SE-COPE).

Participant engagement as assessed by rates of participant recruitment and proportion of eligible participants who are enrolled in the study

时间窗: 3-months

Participant satisfaction at mid- and post-intervention (quantitative)

时间窗: 3-months

Mean scores (ranging from 1 to 5) on ten Likert items assessing length of the program, pace of learning and discussing material, group format, meeting time and location, group facilitator, and program materials (i.e., amount of information given, clarity of the information given, ability to understand information, ability to apply material in real life). One additional item will ask how participants would rate the helpfulness of the FEELS intervention (1 = very unhelpful to 5 = very helpful).

Participant satisfaction at post-intervention (qualitative)

时间窗: 3-months

Three survey questions will ask participants for feedback on the intervention (facilitators for participation, topics to include in the future, and suggestions for improvement). Post-intervention focus groups will also elicit qualitative appraisals (on intervention length, pace, and modality; ease of reading, understanding, and applying the content; and suggestions for improvement) from a smaller group of intervention participants.

Participant retention and attendance at sessions

时间窗: 3-months

Mean number of intervention sessions attended per participant and proportion of participants who complete the full intervention

次要结局

  • Mental health help-seeking behaviors(3-months)
  • Changes in scores on the Short PTSD Rating Interview (SPRINT)(3-months)
  • Changes in scores on the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)(3-months)

研究者

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

Alexandria Bauer, PhD

Assistant Professor

Rutgers, The State University of New Jersey

研究点 (1)

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