Culture and Well-Being for Latinos

NCT05244733 | Completed DMC

• 2 other identifiers: STUDY00006325K23MH125078
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness; Suicidal Ideation; Social Isolation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change in Suicide Risk (A)

  Baseline and 10 weeks

• Change in Suicide Risk (B)

  Baseline and 10 weeks

Study Arms (2)

Social Engage (S-ENGAGE)

EXPERIMENTAL

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)

The Healthy Lifestyles Education Program

PLACEBO COMPARATOR

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

Interventions

Social Engage (S-ENGAGE) BEHAVIORAL

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.

Social Engage (S-ENGAGE)

The Healthy Lifestyles Education Program BEHAVIORAL

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.

The Healthy Lifestyles Education Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[C-SSRS\]).

You may not qualify if:

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

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Social Isolation; Suicidal Ideation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Suicide; Self-Injurious Behavior; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: June 1, 2022
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)