Culture and Well-Being for Latinos
- Conditions
- Suicidal IdeationSocial IsolationLoneliness
- Interventions
- Behavioral: Social Engage (S-ENGAGE)Behavioral: The Healthy Lifestyles Education Program
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 65
- 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]).
- 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
- Arm && Interventions
Group Intervention Description Social Engage (S-ENGAGE) 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. The Healthy Lifestyles Education Program 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.
- 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