Project HOPEFUL: A PN-RCT With Implementation Science
University of Florida · with University of Louisiana at Lafayette, Virginia Polytechnic Institute and State University · NCT07475039
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 55+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 400
- US sites recruiting
- 1
- Study start
- September 5, 2025
- Record last updated
- March 16, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: 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
Conditions: Older Adults (50-90 Years); Mental Health; Depression and Suicide Ideation; Social Functioning; Quality of Life; Thwarted Belongingness; Perceived Burdensomeness
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
In order to be eligible as a participant in this study, an individual must meet all of the following criteria:
- Provision of verbal informed consent
- Classify as an Older Adult (65+)
- Stated willingness and ability to comply with all study procedures
- Receive home and community-based services (HCBS) through the Aging Services Network (i.e. HDM (home delivered meals services), CM (congregate meals), etc.)
- 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:
- Provision of written informed consent
- State willingness to comply with all study procedures
- Be a staff or volunteer within the ASN (Aging Services Network), specifically within the triple As and aging entities we have partnered with
- 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)
- 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:
- Provision of written informed consent
- State willingness to comply with all study procedures
- 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
- Had a dementia diagnosis, or another form of cognitive impairment, and/or hearing impairment that would preclude phone conversation.
- Participation in another warm calling behavioral treatment or intervention study simultaneously occurring
Exclusion criteria for trained natural helpers:
- 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)
- Participation in another warm calling behavioral treatment or intervention study simultaneously occurring
Exclusion criteria for aging leaders
- Has not worked with the study team directly in implementing the 8-week treatment
- Is not familiar with the implementation of the program
Recruiting US locations
University of Florida
Gainesville, FL 32611
Study contacts (from the official record)
- Laura R Shannonhouse, PhD · 352-273-4332 · lshannonhouse@coe.ufl.edu
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