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Recruiting NCT07529509

Abriendo Caminos: Engaging Latinos

No phase Interventional Serious Mental Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Culturally responsive motivational interviewing.
Who it may be relevant to
Registry conditions: Serious Mental Illness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Abriendo Caminos: Engaging Latino Communities Through Culturally Responsive Peer Delivered Motivational Interviewing

Overview

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.

Interventions

  • Behavioral Culturally responsive motivational interviewing
    Six sixty-minute sessions of culturally responsive motivational interviewing, once a week.

Primary outcome measures

  • Number of participants recruited [Time frame: 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]
  • Number of sessions completed [Time frame: 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]
  • Number of assessments completed [Time frame: From enrollment to the end of treatment at 6 weeks]
  • Qualitative acceptability questions [Time frame: End of treatment at 6 weeks]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 2 centers
  • Fellowship Place — New Haven
  • Program for Recovery and Community Health — New Haven

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. PMID 21770786
  • 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. PMID 2632237
  • 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. PMID 3315590
  • Friedman 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. PMID 2864952
  • Rabinowitz 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. PMID 3976969
  • Faulkner 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. PMID 4303048
  • 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. PMID 28900779
  • 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. PMID 24588455

Identifiers

NCT: NCT07529509 · 2000034687 · 5K23MH130718

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗