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Clinical Trials/NCT05244733
NCT05244733
Completed
N/A

Culture and Well-Being for Latinos: Study Protocol for Cultural-Social Engagement and Suicide Among Hispanics (K23MH125078)

University of Rochester1 site in 1 country54 target enrollmentJune 1, 2022

Overview

Phase
N/A
Intervention
Social Engage (S-ENGAGE)
Conditions
Social Isolation
Sponsor
University of Rochester
Enrollment
54
Locations
1
Primary Endpoint
Change in Cultural-Social Engagement (A)
Status
Completed
Last Updated
3 months ago

Overview

Brief Summary

The proposed K23 study is an intervention study using an experimental therapeutics approach. This pilot RCT asks: "Does SOCIAL-ENGAGE increase cultural-social engagement and decrease suicide risk among Spanish-speaking adults?" We will first optimize a behavioral intervention - SOCIAL ENGAGE (S-ENGAGE) - for target engagement using human-centered design approaches with Spanish-speaking adults at risk for suicide (n=5) and then conduct a pilot RCT (n=60) to test target engagement (cultural-social engagement) and clinical impact (suicide risk) of S-ENGAGE with this population. The ultimate goal is for S-ENGAGE to be offered as a suicide prevention program for Hispanics at risk for suicide.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
September 19, 2025
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Caroline Silva

Assistant Professor

University of Rochester

Eligibility Criteria

Inclusion Criteria

  • Identify as Hispanic/Latino adult (age 18+);
  • Primary Spanish-Speaker;
  • Patient in the UR health system;
  • Low cultural-social engagement (i.e., score ≤ 2 on the adapted Berkman-Syme Social Network Index);
  • Elevated suicide risk (i.e., presence of passive or active suicide ideation in the past month on the Columbia-Suicide Severity Rating Scale \[C-SSRS\]).

Exclusion Criteria

  • Medical or psychiatric comorbidities that impair ability to consent (e.g., active psychotic or manic episode, cognitive impairment).

Arms & Interventions

Social Engage (S-ENGAGE)

S-ENGAGE is a skills-based psychotherapy that focuses on helping patients engage in meaningful rewarding social activities. Subjects will receive 10 one-hour individual sessions of S-ENGAGE over 10 weeks.

Intervention: Social Engage (S-ENGAGE)

The Healthy Lifestyles Education Program

The healthy lifestyles education program consists of a notebook containing evidence-based educational material on mental health, physical activity, and information on community resources. Study staff meet with participants once, individually, for 1 hour to review each section and answer questions participants might have.

Intervention: The Healthy Lifestyles Education Program

Outcomes

Primary Outcomes

Change in Cultural-Social Engagement (A)

Time Frame: Baseline and 10 weeks

Average number of cultural-social interactions (measured via EMA), with greater number indicating greater cultural-social engagement (i.e., better outcome).

Change in Cultural-Social Engagement (B)

Time Frame: Baseline and 10 weeks

Time spent in positive Spanish-language conversations (measured via passive monitoring of conversations), with more time indicating greater cultural-social engagement (i.e., better outcome).

Change in Cultural-Social Engagement (C)

Time Frame: Baseline and 10 weeks

Number of visits to cultural-social settings outside the home (measured via GPS), with greater number indicating greater cultural-social engagement (i.e., better outcome).

Change in Cultural-Social Engagement (D)

Time Frame: Baseline and 10 weeks

Self-reported feelings of belonging to Hispanic cultural groups (measured via EMA with the Interpersonal Needs Questionnaire), with greater scores indicating greater cultural-social engagement (i.e., better outcome).

Secondary Outcomes

  • Change in Suicide Risk (A)(Baseline and 10 weeks)
  • Change in Suicide Risk (B)(Baseline and 10 weeks)

Study Sites (1)

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