Culture and Well-Being for Latinos

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05244733
• Other study ID #: STUDY00006325
• Secondary ID: K23MH125078
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2024
• Source: University of Rochester
• Contact: Caroline Silva, PhD
• Phone: 585-275-2392
• Email: caroline_silva[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Loneliness
• Social Isolation
• Suicidal Ideation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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