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NCT Number: NCT07378254

Finding Emotional Empowerment and Lifelong Strength

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.

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Key information

Conditions

Trauma and Stressor Related Disorders Chemically-Induced Disorders Mental Disorders Substance Use Substance-Related Disorders Wounds and Injuries

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Alcohol & Substance Use Studies

Piscataway, New Jersey, 08854, United States

Location status: Recruiting

Location contact

Alexandria G. Bauer

CONTACT

[email protected]

848-209-1032

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Finding Emotional Empowerment and Lifelong Strength

Behavioral

A group-based, 12-week educational intervention to help promote mental health literacy and related beliefs, especially related to trauma and substance use.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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).

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

    Time frame: 3-months

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

    Time frame: 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).

  7. Participant satisfaction at post-intervention (qualitative)

    Time frame: 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.

  8. Participant retention and attendance at sessions

    Time frame: 3-months

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

Secondary outcomes

  1. Mental health help-seeking behaviors

    Time frame: 3-months

    Five questions will include looking for a mental health provider nearby, finding out whether insurance would cover a visit to a mental health provider, making an appointment, following through on the appointment, and/or visiting a provider more than once. Items will be scored as 1 = Yes and 0 = No.

  2. Changes in scores on the Short PTSD Rating Interview (SPRINT)

    Time frame: 3-months

    Mean scores ranging from 0 to 4, with higher scores indicating greater PTSD symptoms.

  3. Changes in scores on the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)

    Time frame: 3-months

    Mean frequency of past 3-month substance use, ranging from 0 to 6, with higher scores indicating greater substance use.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandria Bauer, PhD

CONTACT

[email protected]

848-209-1032

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: FEELS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 30, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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