Project HOPEFUL: A PN-RCT With Implementation Science

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07475039
Status
Recruiting
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Conditions

  • Depression and Suicide Ideation
  • Mental Health
  • Older Adults (50-90 Years)
  • Perceived Burdensomeness
  • Quality of Life
  • Social Functioning
  • Thwarted Belongingness

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Standardized and manualized warm calls from providers trained in the BE training — BEHAVIORAL
    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 — BEHAVIORAL
    Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration; with a 6 month follow up.

Study Details

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.

Key Dates

Start date
Sep 5, 2025
Status verified
Nov 2025
Primary completion
Aug 30, 2030
Completion
Aug 30, 2030

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

Social Provisions Scale (SPS-5) [ Time Frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611-

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By research site
University of Florida· Gainesville, FL

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