Recruiting

BE & BE + ASISTProject HOPEFUL: A PN-RCT With Implementation Science

Sponsor:

University of Florida

Code:

NCT07475039

Conditions

Older Adults (50-90 Years)

Mental Health

Depression and Suicide Ideation

Social Functioning

Quality of Life

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

Standardized and manualized warm calls from providers trained in the BE training

Standardized and manualized warm calls from providers trained in the BE training + ASIST training

Study Details

Brief summary:

This PN-RCT replicates and evaluates an 8-week warm calling treatment (i.e. caring contacts) delivered to older adults receiving home and community-based services (HCBS; classified as "homebound") in 20-30 minute call "dosages", across 3 conditions, while adding in implementation science measures at multiple levels. Conditions include 2 treatment (i.e. treatment provided by helpers trained in a standardized and manualized Belongingness and Empathy training grounded in narrative reminiscence and the befriending literature (BE condition), and treatment provided by helpers trained in BE + a standardized, manualized, and evidence based suicide intervention training, the Aging Variant of LivingWorks ASIST (BE + ASIST condition), and 1 control (no treatment during the trial; opportunity to receive treatment after the 8 weeks). At the conclusion of treatment, acceptability, appropriateness, feasibility, useability, and sustainability of the program will be evaluated by interventionists, senior center leadership, and regional leadership.

Conditions

Older Adults (50-90 Years)

Mental Health

Depression and Suicide Ideation

Social Functioning

Quality of Life

Study ID

NCT07475039

Start date

Sep 5, 2025

Status verified date

Nov, 2025

Completion date

Aug 30, 2030

Anticipated

Primary completion date

Aug 30, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

In order to be eligible as a participant in this study, an individual must meet all of the following criteria:

1. Provision of verbal informed consent
2. Classify as an Older Adult (65+)
3. Stated willingness and ability to comply with all study procedures
4. Receive home and community-based services (HCBS) through the Aging Services Network (i.e. HDM (home delivered meals services), CM (congregate meals), etc.)
5. Be affiliated with the triple As and aging entities we have partnered with

In order to be eligible to be a trained provider in this study, an individual must meet all of the following criteria:

1. Provision of written informed consent
2. State willingness to comply with all study procedures
3. Be a staff or volunteer within the ASN (Aging Services Network), specifically within the triple As and aging entities we have partnered with
4. Meet Wymann and colleagues (2008) criteria for being a "natural helpers"42 (i.e. be warm, empathic, and having ongoing interaction with participants through one's job role)
5. Be recommended by the aging entity leadership as meeting these qualifications

In order to be eligible to be a leadership personnel in this study, an individual must meet all of the following criteria:

1. Provision of written informed consent
2. State willingness to comply with all study procedures
3. Be a in a leadership position within the aging entity or triple A in which we partnered, and have worked with the study team in helping implement the 8 week program

Exclusion criteria for Participants:

1. Had a dementia diagnosis, or another form of cognitive impairment, and/or hearing impairment that would preclude phone conversation.
2. Participation in another warm calling behavioral treatment or intervention study simultaneously occurring

Exclusion criteria for trained natural helpers:

1. Does not have ongoing interactions with potential old adult participants (i.e. is a part of an optimized nutrition service provider in which they do not serve the same older adults consistently over time)
2. Participation in another warm calling behavioral treatment or intervention study simultaneously occurring

Exclusion criteria for aging leaders:

1. Has not worked with the study team directly in implementing the 8-week treatment
2. Is not familiar with the implementation of the program

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BE condition

BE condition which involves receiving call dosages from providers trained to foster belongingness and empathy (2 hours), grounded in the befriending literature35,36, and narrative reminiscence37. Aging Network Providers trained in BE provide a "small dose of sincere connection", through narrative reminiscence, and the "befriending" strategies.

While the majority of the warm calling of BE WITH centers on this basic connections intervention, there is a brief module on suicide risk.

While this basic "reciprocally caring relationships" treatment will be enough for the majority of participants, there will also be individuals who need more than connection, but rather targeted suicide intervention as approximately 20% of older adults receiving home and community-based services are at risk of suicide38.

experimental: BE + ASIST condition

BE + ASIST condition includes receiving call dosages from providers trained in BE + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training)40. Those older adults assigned to this treatment condition will have both the connections intervention, as well as suicide interventions in the chance that a suicide intervention is needed.

no intervention: Control

Control group includes no treatment, or call dosages during the 8 weeks. Every two weeks graduate research students administer the measure set, just as they did for the 2 treatment conditions. However, after the 8 weeks, these older adult participants have the opportunity to receive the call dosages (delayed waitlist control).

Interventions

Standardized and manualized warm calls from providers trained in the BE training

Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration; with a 6 month follow up.

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; with a 6 month follow up.

Primary outcome measure

Social Provisions Scale (SPS-5) [ Time Frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up ]
University of California, Los Angeles Loneliness Scale [ Time Frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up ]
Patient Health Questionnaire - PHQ-9 [ Time Frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up ]
Short Form Health Survey (SF-12) [ Time Frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up ]
Interpersonal Needs Questionnaire (INQ-15) [ Time Frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up ]
Implementation Science Sustainability Survey Measures: AIM [ Time Frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up ]
Implementation Science Sustainability Survey Measures: IAM [ Time Frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up ]
Implementation Science Sustainability Survey Measures: FIM [ Time Frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up ]
Implementation Science Sustainability Survey Measures: SUS [ Time Frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up ]
Household Food Security Survey Module - 10 item (Adult Only) [ Time Frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up ]

Central Contacts and Locations

Central contacts

Laura R Shannonhouse, PhD

352-273-4332 lshannonhouse@coe.ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

More Information

Sponsor

University of Florida

Last update posted

Mar 16, 2026

Last verified

Nov, 2025

Keywords

Older adults
Intervention trial
Suicidality
Home Bound Meals
warm-calling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-03-16.