NCT07529509

Brief 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. 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
15mo left

Started Apr 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Aug 2027

Study Start

First participant enrolled

April 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 7, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

SMILatinoPeerRecoveryEngagement

Outcome Measures

Primary Outcomes (6)

  • 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

Secondary Outcomes (16)

  • Religious Practices and beliefs (RPB 2I)

    At enrollment

  • Marin Short Acculturation Scale for Hispanics (SASH)

    At enrollment

  • The Multigroup Ethnic Identity Measure-Revised

    At enrollment

  • Familism Scale

    At enrollment

  • Life Events Checklist for DSM-5 (LEC-5)

    At enrollment

  • +11 more secondary outcomes

Study Arms (1)

Culturally responsive peer-delivered motivational interviewing

EXPERIMENTAL

Six sixty-minute culturally responsive motivational interviewing sessions, once a week.

Behavioral: Culturally responsive motivational interviewing

Interventions

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

Culturally responsive peer-delivered motivational interviewing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet criteria for serious mental illness
  • Not in treatment
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fellowship Place

New Haven, Connecticut, 06511, United States

Location

Program for Recovery and Community Health

New Haven, Connecticut, 06513, United States

Location

Related Publications (14)

  • 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: 21770786BACKGROUND
  • 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: 2632237BACKGROUND
  • 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: 3315590BACKGROUND
  • 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: 2864952BACKGROUND
  • 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: 3976969BACKGROUND
  • 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: 4303048BACKGROUND
  • 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: 28900779BACKGROUND
  • 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: 24588455BACKGROUND
  • Kanter 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.

    PMID: 20176914BACKGROUND
  • Valman 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.

    PMID: 6802339BACKGROUND
  • Matveeva 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.

    PMID: 4780300BACKGROUND
  • 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.

    PMID: 15176761BACKGROUND
  • 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.

    PMID: 31851706BACKGROUND
  • 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.

    PMID: 29241431BACKGROUND

Study Officials

  • Oscar F Rojas Perez, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar F Rojas Perez, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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

Locations