Trauma and Stressor Related DisordersFEELSNCT07378254
Finding Emotional Empowerment and Lifelong Strength
A study testing Finding Emotional Empowerment and Lifelong Strength in people with Trauma and Stressor Related Disorders and Substance Use, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma and Stressor Related Disorders, Substance Use
- What is being tested?
- Finding Emotional Empowerment and Lifelong Strength
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center of Alcohol & Substance Use Studies
Piscataway, New Jersey, 08854
Alexandria G. Bauer, 848-209-1032, alexandria.bauer@rutgers.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- Finding Emotional Empowerment and Lifelong Strength
- Keywords
- mental health literacy, trauma, substance use, psychoeducation, Black and African American, young adults
- Medical subject headings
- Trauma and Stressor Related Disorders, Substance-Related Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finding Emotional Empowerment and Lifelong StrengthBehavioural
A group-based, 12-week educational intervention to help promote mental health literacy and related beliefs, especially related to trauma and substance use.
| Study group | Role | What they receive |
|---|---|---|
| FEELS | Experimental | Finding Emotional Empowerment and Lifelong Strength Receives: Behavioral: Finding Emotional Empowerment and Lifelong Strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores on the Multicomponent Mental Health Literacy Measure (MMHLM)
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.
Measured: 3-months
Change in scores on the Short Attitudes Towards Mental Health Problems Scale (SATMHPS)
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.
Measured: 3-months
Change in scores on the Mental Help Seeking Intention Scale (MHSIS)
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.
Measured: 3-months
Change in scores on the Self-Efficacy in Seeking Mental Health Care (SE-SMHC)
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).
Measured: 3-months
Participant engagement as assessed by rates of participant recruitment and proportion of eligible participants who are enrolled in the study
Measured: 3-months
Participant satisfaction at mid- and post-intervention (quantitative)
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).
Measured: 3-months
Participant satisfaction at post-intervention (qualitative)
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.
Measured: 3-months
Participant retention and attendance at sessions
Mean number of intervention sessions attended per participant and proportion of participants who complete the full intervention
Measured: 3-months
Secondary outcomes (3)
Mental health help-seeking behaviors
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.
Measured: 3-months
Changes in scores on the Short PTSD Rating Interview (SPRINT)
Mean scores ranging from 0 to 4, with higher scores indicating greater PTSD symptoms.
Measured: 3-months
Changes in scores on the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
Mean frequency of past 3-month substance use, ranging from 0 to 6, with higher scores indicating greater substance use.
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start10 Mar 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma and Stressor Related DisordersStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Alexandria Bauer, PhD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378254
- Sponsor's protocol ID
- Pro2023000454
- Other IDs
- 1K01MH131797-01
- Acronym
- FEELS
- Status last verified
- Jun 2026
- First submitted
- 18 Jul 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-Producing a Trauma and Substance Use Mental Health Literacy Intervention
- ClinicalTrials.gov ID
- NCT07378254
- Acronym / sponsor ID
- FEELS / Pro2023000454
- Keywords
- mental health literacy, trauma, substance use, psychoeducation, Black and African American, young adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FEELS | Experimental | Behavioral: Finding Emotional Empowerment and Lifelong StrengthFinding Emotional Empowerment and Lifelong Strength |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finding Emotional Empowerment and Lifelong StrengthA group-based, 12-week educational intervention to help promote mental health literacy and related beliefs, especially related to trauma and substance use. | Behavioural | FEELS |
Primary outcome
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.
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.
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.
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).
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
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)
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.
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 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finding Emotional Empowerment and Lifelong Strength in people with Trauma and Stressor Related Disorders and Substance Use, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandria Bauer, PhD (848-209-1032, alexandria.bauer@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores on the Multicomponent Mental Health Literacy Measure (MMHLM) (time frame: 3-months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.