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Recruiting NCT07378254

Finding Emotional Empowerment and Lifelong Strength

No phase Interventional Trauma and Stressor Related Disorders Substance Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Finding Emotional Empowerment and Lifelong Strength.
Who it may be relevant to
Registry conditions: Trauma and Stressor Related Disorders, Substance Use. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Finding Emotional Empowerment and Lifelong Strength
    A group-based, 12-week educational intervention to help promote mental health literacy and related beliefs, especially related to trauma and substance use.

Primary outcome measures

  • Change in scores on the Multicomponent Mental Health Literacy Measure (MMHLM) [Time frame: 3-months]
  • Change in scores on the Short Attitudes Towards Mental Health Problems Scale (SATMHPS) [Time frame: 3-months]
  • Change in scores on the Mental Help Seeking Intention Scale (MHSIS) [Time frame: 3-months]
  • Change in scores on the Self-Efficacy in Seeking Mental Health Care (SE-SMHC) [Time frame: 3-months]
  • Participant engagement as assessed by rates of participant recruitment and proportion of eligible participants who are enrolled in the study [Time frame: 3-months]
  • Participant satisfaction at mid- and post-intervention (quantitative) [Time frame: 3-months]
  • Participant satisfaction at post-intervention (qualitative) [Time frame: 3-months]
  • Participant retention and attendance at sessions [Time frame: 3-months]
Secondary outcome measures (3)
  • Mental health help-seeking behaviors [Time frame: 3-months]
  • Changes in scores on the Short PTSD Rating Interview (SPRINT) [Time frame: 3-months]
  • Changes in scores on the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) [Time frame: 3-months]

Eligibility criteria

Inclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Center of Alcohol & Substance Use Studies — Piscataway

Identifiers

NCT: NCT07378254 · Pro2023000454 · 1K01MH131797-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗