- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07378254
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
Status
Recruiting
Intervention / Treatment
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
- Name: Alexandria Bauer, PhD
- Phone Number: 848-209-1032
- Email: alexandria.bauer@rutgers.edu
Study Locations
-
-
New Jersey
-
Piscataway, New Jersey, United States, 08854
- Recruiting
- Center of Alcohol & Substance Use Studies
-
Contact:
- Alexandria G. Bauer
- Phone Number: 6192443505
- Email: alexandria.bauer@rutgers.edu
-
-
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:
- 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.
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.
Collaborators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2023000454
- 1K01MH131797-01 (U.S. NIH Grant/Contract)
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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