Culture and Well-Being for Latinos

Study Overview
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Brief Summary
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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.

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

Conditions
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Social Isolation, Loneliness, Suicidal Ideation

Intervention / Treatment
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* Behavioral: Social Engage (S-ENGAGE)
* Behavioral: The Healthy Lifestyles Education Program


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social Engage (S-ENGAGE)<br>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)<br>* 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.<br>|
| Placebo Comparator: The Healthy Lifestyles Education Program<br>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<br>* 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.<br>|

What is the study measuring?
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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 |