[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07378254":3,"trial-entities:NCT07378254":107,"trial-summary:NCT07378254":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":28,"primary_purpose":14,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":40,"secondary_outcomes":65,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":78,"eligibility_criteria":79,"std_ages":83,"locations":85,"central_contacts":101,"overall_officials":104,"references":105,"see_also_links":106},"NCT07378254","Pro2023000454","Finding Emotional Empowerment and Lifelong Strength","Co-Producing a Trauma and Substance Use Mental Health Literacy Intervention","RECRUITING","2028-06","2026-06","2026-06-18","2026-03-10","Rutgers, The State University of New Jersey","OTHER",false,"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.","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.",[19,20],"Trauma and Stressor Related Disorders","Substance Use",[22,23,24,25,26,27],"mental health literacy","trauma","substance use","psychoeducation","Black and African American","young adults","INTERVENTIONAL",[30],"NA",{"count":32,"type":33},80,"ESTIMATED",[35],{"type":36,"name":6,"description":37,"armGroupLabels":38},"BEHAVIORAL","A group-based, 12-week educational intervention to help promote mental health literacy and related beliefs, especially related to trauma and substance use.",[39],"FEELS",[41,45,48,51,54,56,59,62],{"measure":42,"description":43,"timeFrame":44},"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",{"measure":46,"description":47,"timeFrame":44},"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.",{"measure":49,"description":50,"timeFrame":44},"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.",{"measure":52,"description":53,"timeFrame":44},"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).",{"measure":55,"timeFrame":44},"Participant engagement as assessed by rates of participant recruitment and proportion of eligible participants who are enrolled in the study",{"measure":57,"description":58,"timeFrame":44},"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).",{"measure":60,"description":61,"timeFrame":44},"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.",{"measure":63,"description":64,"timeFrame":44},"Participant retention and attendance at sessions","Mean number of intervention sessions attended per participant and proportion of participants who complete the full intervention",[66,69,72],{"measure":67,"description":68,"timeFrame":44},"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\u002For visiting a provider more than once. Items will be scored as 1 = Yes and 0 = No.",{"measure":70,"description":71,"timeFrame":44},"Changes in scores on the Short PTSD Rating Interview (SPRINT)","Mean scores ranging from 0 to 4, with higher scores indicating greater PTSD symptoms.",{"measure":73,"description":74,"timeFrame":44},"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.","ALL","18 Years","35 Years",true,{"inclusion":80,"exclusion":81,"raw_text":82},[],[],"Inclusion Criteria:\n\n1. Self-identify as Black or African American\n2. Be between the ages of 18 and 35 years old\n3. Endorse previous lifetime trauma exposure\n4. Participants must speak English\n5. Participants are capable of giving informed consent and capable of complying with study procedures.",[84],"ADULT",[86],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":98},"Center of Alcohol & Substance Use Studies","Piscataway","New Jersey","08854","United States",[93],{"name":94,"role":95,"phone":96,"email":97},"Alexandria G. Bauer","CONTACT","848-209-1032","alexandria.bauer@rutgers.edu",{"lat":99,"lon":100},40.49927,-74.39904,[102],{"name":103,"role":95,"phone":96,"email":97},"Alexandria Bauer, PhD",[],[],[],{"nct_id":4,"conditions":108,"biomarkers":109},[20,19],[],{"nct_id":4,"found":78,"summary":111,"prompt_version":121},{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This is an interventional study with a planned enrollment of 80 participants. It will use a single-arm pilot design, meaning all participants will receive the intervention.","completed","Finding Emotional Empowerment and Lifelong Strength for Trauma and Substance Use","This study is testing a 12-week group program called \"Finding Emotional Empowerment and Lifelong Strength\" (FEELS). The program aims to improve your understanding and beliefs about mental health, especially concerning trauma and substance use. Researchers want to see if this program can help young Black adults, aged 18 to 35, who have experienced trauma. The study will measure changes in your mental health understanding, attitudes towards mental health problems, and your intention to seek mental health help over three months. The current status of this study is unclear, and it plans to enroll 80 participants.","Participants will be followed for three months after the intervention to measure changes in mental health literacy and related beliefs.",95,"You would participate in 12 weeks of educational group sessions and complete assessments at the beginning, middle, and end of the program.","Not stated in the trial record.",[6],"v2"]