Culture and Well-Being for Latinos

University of Rochester

Status: Completed

Conditions: Suicidal Ideation; Loneliness; Social Isolation

Treatments: Behavioral: The Healthy Lifestyles Education Program; Behavioral: Social Engage (S-ENGAGE)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05244733

K23MH125078 (U.S. NIH Grant/Contract)

STUDY00006325

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups, including a placebo group

Social Engage (S-ENGAGE)

Experimental group

Description:

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.

Treatment:

Behavioral: Social Engage (S-ENGAGE)

The Healthy Lifestyles Education Program

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: The Healthy Lifestyles Education Program