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Completed

NCT Number: NCT05244733

Culture and Well-Being for Latinos

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.

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Key information

Conditions

Social Isolation Behavior Behavioral Symptoms Loneliness Self-Injurious Behavior Social Behavior Suicidal Ideation Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Social Engage (S-ENGAGE)

Behavioral

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

Behavioral

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2022
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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