Culture and Well-Being for Latinos

• ClinicalTrials.gov Identifier: NCT05244733
• Recruitment Status: Recruiting
• First Posted: February 17, 2022
• Last Update Posted: June 21, 2022
• Sponsor: University of Rochester
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Caroline Silva, University of Rochester

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Social Isolation; Loneliness; Suicidal Ideation	Behavioral: Social Engage (S-ENGAGE); Behavioral: The Healthy Lifestyles Education Program	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Culture and Well-Being for Latinos: Study Protocol for Cultural-Social Engagement and Suicide Among Hispanics (K23MH125078)
• Actual Study Start Date: June 1, 2022
• Estimated Primary Completion Date: October 31, 2024
• Estimated Study Completion Date: October 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in Cultural-Social Engagement (A) [ Time Frame: 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).
2. Change in Cultural-Social Engagement (B) [ Time Frame: 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).
3. Change in Cultural-Social Engagement (C) [ Time Frame: 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).
4. Change in Cultural-Social Engagement (D) [ Time Frame: 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 :

1. Change in Suicide Risk (A) [ Time Frame: 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).
2. Change in Suicide Risk (B) [ Time Frame: 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).

Eligibility Criteria

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

Criteria

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).

Contacts and Locations

Contacts

Contact: Caroline Silva, PhD; 585-275-2392; caroline_silva@urmc.rochester.edu

Locations

United States, New York

University of Rochester Medical Center; Recruiting

Rochester, New York, United States, 14642

Contact: Caroline Silva, PhD 585-275-2392 caroline_silva@urmc.rochester.edu

Sponsors and Collaborators

University of Rochester

National Institute of Mental Health (NIMH)

More Information

• Responsible Party: Caroline Silva, Assistant Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT05244733
• Other Study ID Numbers: STUDY00006325; K23MH125078 ( U.S. NIH Grant/Contract )
• First Posted: February 17, 2022
• Last Update Posted: June 21, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Suicidal Ideation; Suicide; Self-Injurious Behavior; Behavioral Symptoms