NCT07378254

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Jun 2028

First Submitted

Initial submission to the registry

July 18, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

July 18, 2025

Last Update Submit

March 31, 2026

Conditions

Keywords

mental health literacytraumasubstance usepsychoeducationBlack and African Americanyoung adults

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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).

    3-months

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

    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).

    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.

    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

    3-months

Secondary Outcomes (3)

  • Mental health help-seeking behaviors

    3-months

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

    3-months

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

    3-months

Study Arms (1)

FEELS

EXPERIMENTAL

Finding Emotional Empowerment and Lifelong Strength

Behavioral: Finding Emotional Empowerment and Lifelong Strength

Interventions

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

FEELS

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Alcohol & Substance Use Studies

Piscataway, New Jersey, 08854, United States

RECRUITING

MeSH Terms

Conditions

Trauma and Stressor Related DisordersSubstance-Related DisordersWounds and Injuries

Condition Hierarchy (Ancestors)

Mental DisordersChemically-Induced Disorders

Central Study Contacts

Alexandria Bauer, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 18, 2025

First Posted

January 30, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations