Culture and Well-Being for Latinos

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

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.

Study Overview

• Status: Completed
• Conditions: Suicidal Ideation; Loneliness; Social Isolation
• Intervention / Treatment: Behavioral: Social Engage (S-ENGAGE); Behavioral: The Healthy Lifestyles Education Program

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Social Engage (S-ENGAGE); S-ENGAGE uses the process of action planning to foster sustained behavior change. Action planning involves: 1) select a goal; 2) develop ideas to meet this goal; 3) choose one or more of these ideas; 4) identify concrete steps to implement the goal (i.e., form an action plan); 5) identify and address barriers if needed.
Placebo Comparator: 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.	Behavioral: The Healthy Lifestyles Education Program; The healthy lifestyles education program is a self-guided psychoeducational program, including a notebook containing evidence-based educational material on mental health, physical activity, and information on community resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cultural-Social Engagement (A)	Average number of cultural-social interactions (measured via EMA), with greater number indicating greater cultural-social engagement (i.e., better outcome).	Baseline and 10 weeks
Change in Cultural-Social Engagement (B)	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).	Baseline and 10 weeks
Change in Cultural-Social Engagement (C)	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).	Baseline and 10 weeks
Change in Cultural-Social Engagement (D)	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).	Baseline and 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Suicide Risk (A)	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).	Baseline and 10 weeks
Change in Suicide Risk (B)	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).	Baseline and 10 weeks

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): September 19, 2025
• Study Completion (Actual): September 19, 2025

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Behavior; Social Behavior; Suicidal Ideation; Social Isolation
• Other Study ID Numbers: STUDY00006325; K23MH125078 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No