Trials / Completed

CompletedNCT07204444

The BE WITH Project: A Partially Nested Randomized Control Trial (PN-RCT)

Equipping the Aging Network to Address Social Isolation, Loneliness, and Elevated Suicide Risk Among Vulnerable Older Adults: A Partially Nested Randomized Controlled Trial of the BE WITH Innovation

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 671 (actual)

Sponsor: University of Florida · Academic / Other
Sex: All
Age: 55 Years
Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn if the BE WITH (Belonging through Empathy With Intentional Targeted Helping) innovation delivered to older adults improves their mental health. It will also learn about the treatment components that led to improvements. The main questions it aims to answer are: 1. Over the course of the 8 week standardized and manualized warm calling treatment, are mental health outcomes improved for the BE and BE + ASIST (Applied Suicide Intervention Skills Training) treatment conditions relative to a control group? 2. Are there differential outcomes for older adults who start the treatment at low, medium, or high risk? (as defined by a baseline aggregate of measures)? 3. How is this improvement manifested for particular aspects of mental health (i.e. depression, social needs, suicide desire, and overall quality of life)? Participants will: 1. answer questions from a trained data collector to get their baseline, 2. receive 8 weeks of warm calls for 2 months (if assigned to one of the 2 treatment conditions, if assigned to control they will have the option to receive treatment at a later time), and (c) be assessed every 2 weeks.

Detailed description

This study is a partially nested randomized controlled trial research design (PN-RCT) with a two-level structure of clients (level-1) nested within callers (level-2) for the two treatment conditions which receive calls. Given that outcomes for older adults receiving calls from the same treatment provider may be more similar than for those who receive calls from a different provider, the use of multilevel modeling can account for these data dependencies. The investigators will be investigating 1) how our BE WITH (Belonging through Empathy With Intentional Targeted Helping) innovation reduces social isolation, loneliness, and elevated suicidality among home delivered meal and former congregate meal clients and improves their social support and well-being. Social isolation, loneliness, and elevated suicidality will be operationalized through a combination of validated psychometric measures taken before, during, and after the structured 8-week intervention. For older adults receiving calls, data from validated measures will be triangulated with behavioral observations of the older adults' emotional states based upon a structured analysis of recorded audio files. The investigators hypothesize that older adults in both treatment conditions will have reduced: social isolation, loneliness, depression, mental health distress, and suicide desire; and they will have increased: social connection, social support, and well-being over time and in comparison to those in the control condition. The investigators will also investigate 2) how BE WITH improves the frequency of empathic and suicide intervention best practice behaviors by trained nutrition service providers. This will be demonstrated in both real-world settings and in situations where a research confederate presents a clinically heightened risk of social isolation, loneliness, and elevated suicidality. Evaluation of counseling skills and suicide intervention skills is challenging, as observations of caregivers working with clients are required. We hypothesize that those trained in both conditions will demonstrate positive global counseling behaviors; however, those trained in BE WITH will more often employ suicide intervention practices when needed.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	standardized and manualized warm calls from providers trained in the BE training	Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
BEHAVIORAL	standardized and manualized warm calls from providers trained in the BE training + ASIST training	Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration

Timeline

Start date: 2021-06-01
Primary completion: 2024-10-25
Completion: 2024-10-25
First posted: 2025-10-02
Last updated: 2025-11-12
Results posted: 2025-11-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07204444. Inclusion in this directory is not an endorsement.