Loneliness, Social Isolation, Suicidal Ideation
Conditions
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.
Interventions
BEHAVIORALSocial 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.
BEHAVIORALThe 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.
Sponsors
University of Rochester
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed