Project HOPEFUL: A PN-RCT With Implementation Science

NCT07475039 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-03-16

No results posted yet for this study

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
  • Thwarted Belongingness
  • Perceived Burdensomeness

Interventions

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; with a 6 month follow up.

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; with a 6 month follow up.

Sponsors & Collaborators

  • University of Louisiana at Lafayette

    collaborator OTHER
  • Virginia Polytechnic Institute and State University

    collaborator OTHER
  • Georgia State University

    collaborator OTHER
  • University of Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-05
Primary Completion
2030-08-30
Completion
2030-08-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07475039 on ClinicalTrials.gov