Finding Emotional Empowerment and Lifelong Strength (FEELS)

March 31, 2026 updated by: Alexandria Bauer, PhD, Rutgers, The State University of New Jersey

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Recruiting
        • Center of Alcohol & Substance Use Studies
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FEELS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3-months
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-months
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.
3-months
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).
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
3-months
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).
3-months
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.
3-months
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
3-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3-months
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-months
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.
3-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

July 18, 2025

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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