Culture and Well-Being for Latinos

Not Applicable

Recruiting

• Conditions: Suicidal Ideation; Social Isolation; Loneliness

• Registration Number: NCT05244733
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-17
• Study Start: 2022-06-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-10
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Cultural-Social Engagement (A)	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)	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)	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)	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 Outcome Measures

Name	Time	Method
Change in Suicide Risk (A)	Baseline and 10 weeks	Reasons for living total score, measured by the Reasons for Living Inventory, with 48 items rated from 1 to 6, with greater scores indicating greater importance for reasons for living (i.e., better outcome).
Change in Suicide Risk (B)	Baseline and 10 weeks	Suicide ideation total score, measured by the Beck Scale for Suicide Ideation, with scores ranging from 0 to 38, with greater scores indicating greater suicide ideation (i.e., worse outcome).

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States