Abriendo Caminos: Engaging Latinos (AC)

July 17, 2026 updated by: Yale University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Fellowship Place
        • Contact:
        • Principal Investigator:
          • Oscar F Rojas Perez, PhD
      • New Haven, Connecticut, United States, 06513
        • Recruiting
        • Program for Recovery and Community Health
        • Contact:
        • Principal Investigator:
          • Oscar F Rojas Perez, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • History of trauma
  • Have not received any treatment in the past 30 days
  • Willing and able to be contacted for follow-up

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Culturally responsive peer-delivered motivational interviewing
Six sixty-minute culturally responsive motivational interviewing sessions, once a week.
Behavioral: Culturally responsive motivational interviewing
Six sixty-minute sessions of culturally responsive motivational interviewing, once a week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From April 2026 to April 2027 (approximately 1 year)
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
From enrollment to the end of follow-up at 60 days post-session 6
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
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
Number of assessments completed
Time Frame: From enrollment to the end of treatment at 6 weeks
The average number of assessments completed by participants
From enrollment to the end of treatment at 6 weeks
Qualitative acceptability questions
Time Frame: End of treatment at 6 weeks
Participants will participate in qualitative interviews regarding their satisfaction with the intervention
End of treatment at 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Religious Practices and beliefs (RPB 2I)
Time Frame: At enrollment
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).
At enrollment
Marin Short Acculturation Scale for Hispanics (SASH)
Time Frame: At enrollment
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
Time Frame: At enrollment
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
Time Frame: At enrollment
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)
Time Frame: At enrollment
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
Time Frame: From enrollment to the end of follow-up at 60 days post-session 6
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
Time Frame: From enrollment to the end of follow-up at 60 days post-session 6
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
Time Frame: From enrollment to the end of follow-up at 60 days post-session 6
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)
Time Frame: From enrollment to the end of follow-up at 60 days post-session 6
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)
Time Frame: From enrollment to the end of follow-up at 60 days post-session 6
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)
Time Frame: From enrollment to the end of follow-up at 60 days post-session 6
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
Time Frame: From enrollment to the end of follow-up at 60 days post-session 6
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
Time Frame: From enrollment to the end of follow-up at 60 days post-session 6
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)
Time Frame: From enrollment to the end of treatment at 6 weeks
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)
Time Frame: From enrollment to the end of treatment at 6 weeks
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
Time Frame: From enrollment to the end of follow-up at 60 days post-session 6
Binary (yes or no) engaged in treatment
From enrollment to the end of follow-up at 60 days post-session 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Oscar F Rojas Perez, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000034687
  • 5K23MH130718 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Given that the sample is small and coming from a small town, it is possible we run the risk of participants being identified.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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