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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23MH130718 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The goal of this clinical trial is to learn if a culturally responsive peer-delivered motivational interviewing intervention can enhance mental health treatment engagement in Latinos with serious mental illness. The main questions it aims to answer are:
Participants will:
Despite the availability of effective mental health treatment, approximately 47% of Latino adults with trauma and serious mental illness (SMI) are not engaged in treatment. The main goal of this current study is to conduct a pilot study to establish the feasibility and acceptability of implementing a culturally responsive motivational interviewing engagement intervention and to ascertain preliminary evidence of the engagement of hypothesized target mechanisms that may mediate enhanced engagement in mental health treatment. The adapted intervention will be implemented by Latino peers with a single cohort (N=30) of Latinos with SMI and not in treatment. Each peer will carry a caseload of 5-6 participants. All participants who meet the inclusion criteria and are interested in participating will complete pre-intervention (baseline), end-of-six-week-intervention, 30-day, and 60-day follow-ups to determine whether there is an increase in treatment engagement, significant changes in measures, and engagement of target mechanisms. Mental health treatment engagement will be measured in multiple ways: 1) as the binary distinction between those who self-report initiation /re-initiation of formal mental health treatment (i.e., outpatient mental health treatment, psychotherapy, medication) within 60 days of the final adapted session 2) and additional indicators of engagement as determined by (e.g., completion of homework, implementation of skills, number of sessions attended). The intervention will approximate the following schedule: session 1 (psychoeducation on SMI and research participation in the current study), session 2 (exploration of strengths and values), session 3 (identification of areas of growth, session 4 (demystifying mental health myths), session 5 (planning for success), and session 6 (planning for growth). The focus is on the change processes-basic motivational interviewing components: awareness of ambivalence about mental health and about change; pros and cons of changing and staying the same; exploration of values and strengths; exploration of possible future; importance and confidence in engaging in treatment; and desire to plan for change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culturally responsive peer-delivered motivational interviewing | Experimental | Six sixty-minute culturally responsive motivational interviewing sessions, once a week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culturally responsive motivational interviewing | Behavioral | Six sixty-minute sessions of culturally responsive motivational interviewing, once a week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants recruited | The average number of participants recruited to participate in the study | From April 2026 to April 2027 (approximately 1 year) |
| Number of participants that complete the study | The average number of participants who complete the study | From enrollment to the end of follow-up at 60 days post-session 6 |
| Number of sessions completed | The average number of sessions completed by the participant | From enrollment to the end of treatment at 6 weeks |
| The Client Satisfaction Questionnaire | The Client Satisfaction Questionnaire (CSQ-8) uses a 4-point Likert scale (1-4) for each item, typically ranging from "Quite dissatisfied" to "Very satisfied" or similar, for a total of 8 to 32 points. High scores indicate greater satisfaction across nine dimensions of service quality. | From enrollment to the end of treatment at 6 weeks |
| Number of assessments completed | The average number of assessments completed by participants | From enrollment to the end of treatment at 6 weeks |
| Qualitative acceptability questions | Participants will participate in qualitative interviews regarding their satisfaction with the intervention | End of treatment at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Religious Practices and beliefs (RPB 2I) | The Religious Practices and Beliefs (RPB 2I) is a 13-item instrument scored by recoding responses to establish a zero floor, with higher scores indicating greater religiosity. It measures religious beliefs (0-4) and behavioral frequencies (past year/lifetime) using Likert scales (e.g., 0-7 or 1-3) to assess four dimensions: believing, bonding, behaving, and belonging. To ensure a score floor of zero, responses must be recoded before summing. Generally, this means subtracting 1 from the response value (e.g., if using a 1-8 scale, it becomes 0-7). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oscar F Rojas Perez, PhD | Contact | 203-940-7869 | oscar.rojasperez@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Oscar F Rojas Perez, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fellowship Place | Recruiting | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21770786 | Background | Repper J, Carter T. A review of the literature on peer support in mental health services. J Ment Health. 2011 Aug;20(4):392-411. doi: 10.3109/09638237.2011.583947. | |
| 2632237 | Background | Eichele G. Retinoic acid induces a pattern of digits in anterior half wing buds that lack the zone of polarizing activity. Development. 1989 Dec;107(4):863-7. doi: 10.1242/dev.107.4.863. |
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Given that the sample is small and coming from a small town, it is possible we run the risk of participants being identified.
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The six sessions are: session 1 (psychoeducation on SMI and research participation in the current study), session 2 (exploration of strengths and values), session 3 (identification of areas of growth, session 4 (demystifying mental health myths), session 5 (planning for success), and session 6 (planning for growth). The sessions will be delivered by a Latino peer with lived experience.
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| At enrollment |
| Marin Short Acculturation Scale for Hispanics (SASH) | The Marin Short Acculturation Scale for Hispanics (SASH) is a 12-item tool scored by averaging responses, where 1 represents "Only Spanish" and 5 represents "Only English." Higher average scores (closer to 5) indicate higher U.S. acculturation, while lower scores (closer to 1) reflect lower acculturation, and middle scores indicate biculturalism | At enrollment |
| The Multigroup Ethnic Identity Measure-Revised | The Multigroup Ethnic Identity Measure-Revised (MEIM-R) is a 6-item instrument that uses a 4-point or 5-point Likert scale (e.g., 1=Strongly Disagree to 4/5=Strongly Agree) to measure ethnic identity commitment and exploration. Scoring involves calculating the mean of all items, with higher scores indicating a stronger, more developed ethnic identity | At enrollment |
| Familism Scale | The Familism Scale is a 14, 5-point Likert scale (1=Very Much in Disagreement, 5=Very Much in Agreement) measuring familism via three subscales: familial obligations, perceived support, and family as referents. Higher scores indicate stronger familism. | At enrollment |
| Life Events Checklist for DSM-5 (LEC-5) | The Life Events Checklist for DSM-5 (LEC-5) is a 17-item self-report tool measuring lifetime trauma exposure (Criterion A). It screens for events "happened to me," "witnessed it," "learned about it," "part of job," or "not sure," with no official total severity score, but often used to confirm Criterion A for PTSD | At enrollment |
| PCL-5 | The PCL-5 is a 20-item self-report questionnaire assessing DSM-5 PTSD symptoms, scored from 0 ("Not at all") to 4 ("Extremely"), with a total severity score of 0-80. A total score of 31-33 or higher indicates probable PTSD, while a 5-point change represents a response, and 10-20 points indicate clinically meaningful improvement. | From enrollment to the end of follow-up at 60 days post-session 6 |
| Perceived Stress | The Perceived Stress Scale (PSS) is a measure of the degree to which situations in one's life are appraised as stressful. PSS items were designed to tap the degree to which respondents found their lives unpredictable, uncontrollable, and overloading. The PSS comprises 14 items, rated from 0 (never) to 4 (very often). Scores range from 0-56, with higher scores indicating greater perceived stress. | From enrollment to the end of follow-up at 60 days post-session 6 |
| Brief Symptom Inventory | The Brief Symptom Inventory (BSI) is a 53-item self-report tool that measures the intensity of psychological distress (0=not at all, 4=extremely) over seven days. Scores are converted to normalized T-scores (Mean=50, SD=10). A T-score 63 on the Global Severity Index (GSI) or two subscales indicates clinically significant distress; 50-62: moderate-to-high-moderate distress; and < 50: below average or nominal distress. | From enrollment to the end of follow-up at 60 days post-session 6 |
| Barriers to Access to Care Evaluation (BACE-3) | The Barriers to Access to Care Evaluation (BACE-3) is a 30-item self-report tool used to assess attitudinal and structural barriers to seeking mental health services, featuring a 12-item stigma subscale. It utilizes a 4-point Likert scale to measure the extent to what extent items stop, delay, or discourage care, with higher total scores indicating greater barriers to access. Summing all 30 items (ranging from 0 to 90) yields a total barrier burden score. | From enrollment to the end of follow-up at 60 days post-session 6 |
| Internalized Stigma of Mental Illness Inventory (ISMI) | The Internalized Stigma of Mental Illness Inventory (ISMI) is a 29-item self-report questionnaire scoring 1-4 per item, used to measure subjective self-stigma. A mean total score (sum of items divided by number of items) ranging from 1 to 4 is calculated. A higher mean score indicates greater internalized stigma, typically categorized into minimal (1.0-2.0), mild (2.01-2.5), moderate (2.51-3.0), or severe (>3.0). | From enrollment to the end of follow-up at 60 days post-session 6 |
| University of Rhode Island Change Assessment Scale (URICA) | The University of Rhode Island Change Assessment Scale (URICA) is a 32-item self-report tool evaluating motivation to change using a 5-point Likert scale (1=Strongly Disagree to 5=Strongly Agree). It calculates scores for four stages-Precontemplation, Contemplation, Action, and Maintenance-which can be used independently or combined into a continuous "Readiness to Change" formula. Higher scores indicate greater readiness to change. Respondents can score high on more than one stage, reflecting that the stages of change are not always discrete | From enrollment to the end of follow-up at 60 days post-session 6 |
| Empowerment | The Rogers Empowerment Scale is a 28-item self-report tool designed to measure mental health service user empowerment across five factors. It uses a 4-point Likert scale (1=Strongly Agree, 4=Strongly Disagree), with total scores ranging from 28 to 112, where higher scores indicate greater empowerment. | From enrollment to the end of follow-up at 60 days post-session 6 |
| WHO Quality of Life Brief | The WHOQOL-BREF is scored by calculating the mean score for each of the four domains (Physical, Psychological, Social, Environment), and multiplying by 4 to create a 4-20 scale. Finally, these scores are often transformed to a 0-100 scale, where higher scores indicate a higher quality of life. Scores are typically presented as a profile of the four domains rather than a single total score. | From enrollment to the end of follow-up at 60 days post-session 6 |
| Working Alliance Inventory Client - Short Revised (WAI-SR-C) | The Working Alliance Inventory - Short Revised Client version (WAI-SR-C) is a 12-item self-report questionnaire assessing the therapy bond, goals, and tasks. Clients rate items on a 5-point Likert scale (1 = Seldom to 5 = Always), with higher total scores (12-60) indicating a stronger therapeutic alliance. | From enrollment to the end of treatment at 6 weeks |
| Working Alliance Inventory Therapist - Short Revised (WAI-SR-T) | The Working Alliance Inventory - Short Revised - Therapist (WAI-SR-T) is a 12-item self-report questionnaire that measures a therapist's perspective on the alliance with their client. It uses a 5-point Likert scale (1 = Seldom to 5 = Always) to score three subscales (Bond, Goals, Tasks). The total score ranges from 12 to 60, with higher scores reflecting a stronger alliance. | From enrollment to the end of treatment at 6 weeks |
| Treatment engagement | Binary (yes or no) engaged in treatment | From enrollment to the end of follow-up at 60 days post-session 6 |
| Program for Recovery and Community Health | Recruiting | New Haven | Connecticut | 06513 | United States |
|
| 3315590 | Background | Lenhoff SJ, Horak AR, Fraser RC, Scott-Millar RN, Bird AR, Jacobs P, Commerford PJ. Evaluation of the efficacy and safety of anisoylated plasminogen streptokinase activator complex in early myocardial infarction. Preliminary results. Drugs. 1987;33 Suppl 3:186-8. doi: 10.2165/00003495-198700333-00032. No abstract available. |
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| 28900779 | Background | Maura J, Weisman de Mamani A. Mental Health Disparities, Treatment Engagement, and Attrition Among Racial/Ethnic Minorities with Severe Mental Illness: A Review. J Clin Psychol Med Settings. 2017 Dec;24(3-4):187-210. doi: 10.1007/s10880-017-9510-2. |
| 24588455 | Background | Ramos Z, Alegria M. Cultural adaptation and health literacy refinement of a brief depression intervention for Latinos in a low-resource setting. Cultur Divers Ethnic Minor Psychol. 2014 Apr;20(2):293-301. doi: 10.1037/a0035021. Epub 2014 Mar 3. |
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| 15176761 | Background | Mueser KT, Salyers MP, Rosenberg SD, Goodman LA, Essock SM, Osher FC, Swartz MS, Butterfield MI; 5 Site Health and Risk Study Research Committee. Interpersonal trauma and posttraumatic stress disorder in patients with severe mental illness: demographic, clinical, and health correlates. Schizophr Bull. 2004;30(1):45-57. doi: 10.1093/oxfordjournals.schbul.a007067. |
| 31851706 | Background | Rivera-Segarra E, Varas-Diaz N, Santos-Figueroa A. "That's all Fake": Health professionals stigma and physical healthcare of people living with Serious Mental Illness. PLoS One. 2019 Dec 18;14(12):e0226401. doi: 10.1371/journal.pone.0226401. eCollection 2019. |
| 29241431 | Background | Corrigan P, Sheehan L, Morris S, Larson JE, Torres A, Lara JL, Paniagua D, Mayes JI, Doing S. The Impact of a Peer Navigator Program in Addressing the Health Needs of Latinos With Serious Mental Illness. Psychiatr Serv. 2018 Apr 1;69(4):456-461. doi: 10.1176/appi.ps.201700241. Epub 2017 Dec 15. |