Serious Mental IllnessACNCT07529509
Abriendo Caminos: Engaging Latinos
A study testing Culturally responsive motivational interviewing in people with Serious Mental Illness, run by Yale University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Serious Mental Illness
- What is being tested?
- Culturally responsive motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jul 2026to Aug 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet criteria for serious mental illness
- Not in treatment
- 18 years of age or older
- Reside in CT
- Self-identify as Latino
- Speak English and/or Spanish
Show all 9Show fewer
- History of trauma
- Have not received any treatment in the past 30 days
- Willing and able to be contacted for follow-up
Who cannot join
- Individuals in formal mental health treatment in the past 30 days
- Have a life-threatening or unstable medical, surgical, or psychiatric condition
- Inability to provide > 1 form of contact information
- Anticipate being unable to return for a follow-up assessment
- Reported active risk of suicide or homicide
- Fail capacity to consent
- Cognitively impaired
- Currently in jail or other overnight facilities as required by courts or law
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Fellowship Place
New Haven, Connecticut, 06511
Liphahlee (Lee) Marshall, LCSW, 203-401-4227 ext. 1206, lmarshall@fellowshipplace.org
Oscar F Rojas Perez, PhD
- Recruiting
Program for Recovery and Community Health
New Haven, Connecticut, 06513
Oscar F Rojas Perez, PhD, 203-940-7869, oscar.rojasperez@yale.edu
Kimberly Blackman, MSW, (203) 764-8694, kimberly.blackman@yale.edu
About this study
Official title: Abriendo Caminos: Engaging Latino Communities Through Culturally Responsive Peer Delivered Motivational Interviewing
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:
- How feasible is it to recruit 30 Latinos with serious mental illness into a 6 week treatment engagement intervention?
- How acceptable is the intervention to Latinos with serious mental illness?
Participants will:
- Receive six sixty-minute sessions
- Complete weekly measures, along with pre-, post-, 30-day, and 60-day post-intervention assessments
Read the detailed description
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.
- Conditions
- Serious Mental Illness
- Being tested
- Culturally responsive motivational interviewing
- Keywords
- SMI, Latino, Peer, Recovery, Engagement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally responsive motivational interviewingBehavioural
Six sixty-minute sessions of culturally responsive motivational interviewing, once a week.
| Study group | Role | What they receive |
|---|---|---|
| Culturally responsive peer-delivered motivational interviewing | Experimental | Six sixty-minute culturally responsive motivational interviewing sessions, once a week. Receives: Behavioral: Culturally responsive motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited
The average number of participants recruited to participate in the study
Measured: 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
Measured: 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
Measured: 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.
Measured: From enrollment to the end of treatment at 6 weeks
Number of assessments completed
The average number of assessments completed by participants
Measured: 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
Measured: End of treatment at 6 weeks
Secondary outcomes (16)
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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 6 weeks
Treatment engagement
Binary (yes or no) engaged in treatment
Measured: From enrollment to the end of follow-up at 60 days post-session 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start9 Jul 2026
- Primary completionApr 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Serious Mental IllnessStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Oscar F Rojas Perez, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529509
- Sponsor's protocol ID
- 2000034687
- Other IDs
- 5K23MH130718
- Acronym
- AC
- Status last verified
- Jul 2026
- First submitted
- 7 Apr 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given that the sample is small and coming from a small town, it is possible we run the risk of participants being identified.
Publications
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.
PubMed 21770786Eichele 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.
PubMed 2632237Lenhoff 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.
PubMed 3315590Friedman TC, Kline TB, Wilk S. 5-Oxoprolinal: transition-state aldehyde inhibitor of pyroglutamyl-peptide hydrolase. Biochemistry. 1985 Jul 16;24(15):3907-13. doi: 10.1021/bi00336a015.
PubMed 2864952Rabinowitz M, Leviton A, Bellinger D. Home refinishing, lead paint, and infant blood lead levels. Am J Public Health. 1985 Apr;75(4):403-4. doi: 10.2105/ajph.75.4.403.
PubMed 3976969Faulkner RS, Van Rooyen CE. Two new candidate enterovirus serotypes, isolated from CSF. Am J Epidemiol. 1969 Jan;89(1):110-5. doi: 10.1093/oxfordjournals.aje.a120909. No abstract available.
PubMed 4303048Maura 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.
PubMed 28900779Ramos 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.
PubMed 24588455Kanter JW, Santiago-Rivera AL, Rusch LC, Busch AM, West P. Initial outcomes of a culturally adapted behavioral activation for Latinas diagnosed with depression at a community clinic. Behav Modif. 2010 Mar;34(2):120-44. doi: 10.1177/0145445509359682. Epub 2010 Feb 22.
PubMed 20176914Valman HB. ABC of 1 to 7: whooping cough. Br Med J (Clin Res Ed). 1982 Mar 20;284(6319):886-7. doi: 10.1136/bmj.284.6319.886. No abstract available.
PubMed 6802339Matveeva LA. [Dynamics of erythrocytes and some indices in healthy individuals and in children with acute pneumonia]. Pediatriia. 1973 Sep;52(9):51. No abstract available. Russian.
PubMed 4780300Mueser 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.
PubMed 15176761Rivera-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.
PubMed 31851706Corrigan 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.
PubMed 29241431
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abriendo Caminos: Engaging Latino Communities Through Culturally Responsive Peer Delivered Motivational Interviewing
- ClinicalTrials.gov ID
- NCT07529509
- Acronym / sponsor ID
- AC / 2000034687
- Conditions
- Serious Mental Illness
- Keywords
- SMI, Latino, Peer, Recovery, Engagement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 14 Apr 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.
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:
- How feasible is it to recruit 30 Latinos with serious mental illness into a 6 week treatment engagement intervention?
- How acceptable is the intervention to Latinos with serious mental illness?
Participants will:
- Receive six sixty-minute sessions
- Complete weekly measures, along with pre-, post-, 30-day, and 60-day post-intervention assessments
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Culturally responsive peer-delivered motivational interviewing | Experimental | Behavioral: Culturally responsive motivational interviewingSix sixty-minute culturally responsive motivational interviewing sessions, once a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Meet criteria for serious mental illness
- Not in treatment
- 18 years of age or older
- Reside in CT
- Self-identify as Latino
Key exclusion criteria (8 listed)
- Individuals in formal mental health treatment in the past 30 days
- Have a life-threatening or unstable medical, surgical, or psychiatric condition
- Inability to provide > 1 form of contact information
- Anticipate being unable to return for a follow-up assessment
- Reported active risk of suicide or homicide
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 |
|---|---|---|
| Culturally responsive motivational interviewingSix sixty-minute sessions of culturally responsive motivational interviewing, once a week. | Behavioural | Culturally responsive peer-delivered motivational interviewing |
Primary outcome
Number of participants recruited
Time frame: From April 2026 to April 2027 (approximately 1 year)
The average number of participants recruited to participate in the study
Number of participants that complete the study
Time frame: From enrollment to the end of follow-up at 60 days post-session 6
The average number of participants who complete the study
Number of sessions completed
Time frame: From enrollment to the end of treatment at 6 weeks
The average number of sessions completed by the participant
The Client Satisfaction Questionnaire
Time frame: From enrollment to the end of treatment at 6 weeks
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.
Number of assessments completed
Time frame: From enrollment to the end of treatment at 6 weeks
The average number of assessments completed by participants
Qualitative acceptability questions
Time frame: End of treatment at 6 weeks
Participants will participate in qualitative interviews regarding their satisfaction with the intervention
16 secondary outcomes
Religious Practices and beliefs (RPB 2I)
Time frame: At enrollment
Marin Short Acculturation Scale for Hispanics (SASH)
Time frame: At enrollment
The Multigroup Ethnic Identity Measure-Revised
Time frame: At enrollment
Familism Scale
Time frame: At enrollment
Life Events Checklist for DSM-5 (LEC-5)
Time frame: At enrollment
PCL-5
Time frame: From enrollment to the end of follow-up at 60 days post-session 6
Perceived Stress
Time frame: From enrollment to the end of follow-up at 60 days post-session 6
Brief Symptom Inventory
Time frame: From enrollment to the end of follow-up at 60 days post-session 6
Barriers to Access to Care Evaluation (BACE-3)
Time frame: From enrollment to the end of follow-up at 60 days post-session 6
Internalized Stigma of Mental Illness Inventory (ISMI)
Time frame: From enrollment to the end of follow-up at 60 days post-session 6
University of Rhode Island Change Assessment Scale (URICA)
Time frame: From enrollment to the end of follow-up at 60 days post-session 6
Empowerment
Time frame: From enrollment to the end of follow-up at 60 days post-session 6
WHO Quality of Life Brief
Time frame: From enrollment to the end of follow-up at 60 days post-session 6
Working Alliance Inventory Client - Short Revised (WAI-SR-C)
Time frame: From enrollment to the end of treatment at 6 weeks
Working Alliance Inventory Therapist - Short Revised (WAI-SR-T)
Time frame: From enrollment to the end of treatment at 6 weeks
Treatment engagement
Time frame: From enrollment to the end of follow-up at 60 days post-session 6
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 21 Jul 2026.
- Background: PubMed 21770786Repper 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.
- Background: PubMed 2632237Eichele 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.
- Background: PubMed 3315590Lenhoff 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.
- Background: PubMed 2864952Friedman TC, Kline TB, Wilk S. 5-Oxoprolinal: transition-state aldehyde inhibitor of pyroglutamyl-peptide hydrolase. Biochemistry. 1985 Jul 16;24(15):3907-13. doi: 10.1021/bi00336a015.
- Background: PubMed 3976969Rabinowitz M, Leviton A, Bellinger D. Home refinishing, lead paint, and infant blood lead levels. Am J Public Health. 1985 Apr;75(4):403-4. doi: 10.2105/ajph.75.4.403.
- Background: PubMed 4303048Faulkner RS, Van Rooyen CE. Two new candidate enterovirus serotypes, isolated from CSF. Am J Epidemiol. 1969 Jan;89(1):110-5. doi: 10.1093/oxfordjournals.aje.a120909. No abstract available.
- Background: PubMed 28900779Maura 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.
- Background: PubMed 24588455Ramos 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.
- Background: PubMed 20176914Kanter JW, Santiago-Rivera AL, Rusch LC, Busch AM, West P. Initial outcomes of a culturally adapted behavioral activation for Latinas diagnosed with depression at a community clinic. Behav Modif. 2010 Mar;34(2):120-44. doi: 10.1177/0145445509359682. Epub 2010 Feb 22.
- Background: PubMed 6802339Valman HB. ABC of 1 to 7: whooping cough. Br Med J (Clin Res Ed). 1982 Mar 20;284(6319):886-7. doi: 10.1136/bmj.284.6319.886. No abstract available.
- Background: PubMed 4780300Matveeva LA. [Dynamics of erythrocytes and some indices in healthy individuals and in children with acute pneumonia]. Pediatriia. 1973 Sep;52(9):51. No abstract available. Russian.
- Background: PubMed 15176761Mueser 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.
- Individual participant dataSharing planned: No. 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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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.
Oscar F Rojas Perez, PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally responsive motivational interviewing in people with Serious Mental Illness, run by Yale University at 2 sites 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 9 inclusion and 8 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Oscar F Rojas Perez, PhD (203-940-7869, oscar.rojasperez@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited (time frame: From April 2026 to April 2027 (approximately 1 year)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07529509, which also lists 14 linked publications.
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 21 Jul 2026.