Project HOPEFUL: A PN-RCT With Implementation Science

Project HOPEFUL (Helping Older PErsons Find Useful Links): Replicating a Partially Nested Randomized Control Trial With Implementation Science

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Mental Health; Older Adults (50-90 Years); Social Functioning; Depression and Suicide Ideation; Thwarted Belongingness; Perceived Burdensomeness
• Intervention / Treatment: Behavioral: Standardized and manualized warm calls from providers trained in the BE training; Behavioral: Standardized and manualized warm calls from providers trained in the BE training + ASIST training

Detailed Description

This clinical trial replicates and evaluates the BE WITH caring contacts program, equipping the Aging Services Network (ASN) with proven skills to reduce social isolation, loneliness, and elevated suicidality, while also promoting social support/well-being, and learning from the Aging Services Network about what is and is not working for long term sustainability. The study team will also learn specifically what provider behaviors contributed to mental health improvements through the quantitative coding and analysis of audio files as well as the long-term impacts of receiving the 8 week treatment on older adults' social connections and connecting behaviors (6 follow up measurement occasions).

Overall Study Design: 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. 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 treatment provider, the use of multilevel modeling can account for these data dependencies.

Primary Objectives: To (a) replicate the BE WITH Innovation, (b) evaluate the mental health outcomes of older adults receiving HCBS that receive it, while (c) gaining new knowledge on the implementation and sustainability of BE WITH by learning what is and isn't working from interventionists, senior center leadership, and regional leadership.

Secondary Objectives: Enhance the ability of natural helpers to provide standardized, manualized, and evidence based treatment to older adults receiving HCBS.

Primary Endpoint: Reduction in social isolation, loneliness, and elevated suicidality and improved social support/overall quality of life for older adult participants receiving HCBS. New knowledge on the acceptability, appropriateness, feasibility, useability, and sustainability. Secondary Endpoints: Improved frequency of empathic and suicide intervention best practice behaviors by trained providers.

The primary endpoints for older adult participants will be assessed at baseline and every two weeks for a total of 5 measurement occasions, and at 6 month follow up. The primary endpoints for aging network stakeholders will be assessed post-treatment.

Secondary endpoints will be assessed through the quantitative coding of the recorded audio files of treatment dosages. Hypotheses include: (a) participants in the BE and BE + ASIST treatment conditions will experience statistically significant improvements across all measures when compared with those in the control condition over the course of the 8-week treatment, (b) outcome improvements for those in treatment conditions will be more pronounced for those who begin the period at greater risk (assigned high risk tier at baseline), (c) the BE WITH innovation will be found to be appropriate, feasible, and sustainable at multiple levels (i.e. interventionists, senior center leadership, regional leadership), and (d) behavioral improvements in social connections (as a result of building one's social connections plan as part of the treatment) will be found in those that participated in the two treatment groups, and not in the control group.

The study team will also be tracking the long-term outcomes of receiving the treatment on connections and connecting behaviors that older adults have in their life. The implementation of a "connections plan" (CP) within the BE training is a new aspect of this trial. This plan will be introduced in the first call dosage and revisited each call. Evaluations of it will take place at pre and post treatment, with monthly check ins, and then finally at 6 month follow up. The investigators also hypothesize that the connecting behaviors will (a) improve during treatment, and (b) be retained at 6 month follow up.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura R Shannonhouse, PhD; Phone Number: 352-273-4332; Email: lshannonhouse@coe.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Recruiting
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Provisions Scale (SPS-5)	The Social Provisions Scale (SPS-5) is a 5-item measure used to evaluate a participant's level of social support. It is a shortened version of the 10-item SPS and designed for use in research studies to reduce participant burden while maintaining strong psychometric properties. The SPS is based on a theory of social support developed by Irwin Weiss and uses one positive item to assess the social provisions of Attachment, Guidance, Social Integration, Reliable alliance, and Reassurance of worth. Each item is rated on a 4-point Likert scale, from "Strongly Disagree" to "Strongly Agree". Sample items include, "There is someone I could talk to about important decisions in my life", "I feel part of a group of people who share my attitudes and beliefs", and "There are people I can count on in an emergency." A total score is calculated by summing the responses to the 5 questions. The scores can range from 5 to 20, with higher scores indicating higher levels of perceived social support.	Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
University of California, Los Angeles Loneliness Scale	The three-item UCLA Loneliness Scale (Hughes et al., 2004) is a widely used instrument for measuring subjective feelings of loneliness. The scale assesses three core dimensions of loneliness through corresponding items: relational connectedness ("How often do you feel that you lack companionship?"), social connectedness ("How often do you feel left out?"), and self-perceived isolation ("How often do you feel isolated from others?"). Participants respond using a 3-point scale ranging from "hardly ever" to "often." Total scores range from 3 to 9, with higher scores indicating greater loneliness. The scale demonstrates good psychometric properties in middle-aged and older adult populations.	Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
Patient Health Questionnaire - PHQ-9	The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure to assess depressive symptoms in the past 2 weeks (Kroenke et al., 2001). The scale items correspond to the 9 diagnostic criteria for major depressive disorder. Respondents rate the frequency of each symptom on a 4-point scale ranging from "not at all" to "nearly every day." Sample items include "Little interest or pleasure in doing things" and "Poor appetite or overeating." Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. The PHQ-9 includes an additional functional impairment item that assesses how much the problems have affected the respondents' daily activities. The scale has shown strong psychometric properties across diverse populations. Among U.S. older adults, the PHQ-9 showed high sensitivity (88%) and specificity (80%) for identifying major depression, as well as the combination of major and minor depression (Phelan et al., 2010).	Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
Short Form Health Survey (SF-12)	The Short Form Health Survey (SF-12) is a self-reported outcome measure to assess health-related quality of life. The raw answers from the 12 questions are processed to produce two main, standardized summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). We only used the MCS factor in this study as the treatment is targeting mental health. The MCS computed score has a range from 17 to 64 in the analysis and was based on the linear combination of six computed, generated, iterated weights. A low Mental Component Summary (MCS) score indicates poorer self-perceived mental health and lower health-related quality of life.	Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
Interpersonal Needs Questionnaire (INQ-15)	The Interpersonal Needs Questionnaire (INQ; Van Orden et al., 2012) was used to evaluate thwarted belongingness and perceived burdensomeness through 15 items. An adapted version tailored specifically for older adults was used which includes 3-point Likert scale ranging from 1 (Not at all true for me) to 3 (Very true for me). The instrument includes 2 sets of characteristics: (1) the 9-item Thwarted Belongingness (e.g., "I feel disconnected from other people."); and (2) the 6-item Perceived Burdensomeness (e.g., "I think my death would be a relief to the people in my life."). Six questions from the Thwarted Belongingness subscale were reverse-coded when the overall score across questions was computed due to the nature of those questions. In particular, the total score on the INQ is calculated by summing the questions responses to all items and reversing the appropriate ones. As a result, greater scores on each subscale reflect higher levels of the respective construct being measured.	Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
Implementation Science Sustainability Survey Measures: AIM	AIM: The Affect Intensity Measure is a 40-item, self-report questionnaire used in psychology to determine the characteristic strength or weakness with which an individual experiences both positive and negative emotions.4-item instrument measuring the acceptability of an intervention. Item Scale: Each of the 4 items is rated on a 5-point Likert scale, typically ranging from 1 (Completely Disagree) to 5 (Completely Agree). Calculation: The final score is the mean (average) of the four individual item scores. Interpretation: Higher average scores indicate greater perceived acceptability of the intervention among the respondents.	Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
Implementation Science Sustainability Survey Measures: IAM	IAM: The Intervention Appropriateness Measure (IAM) is a 4-item survey used in implementation science to assess the perceived suitability or relevance of a healthcare intervention or implementation strategy. Item Scale: Each of the 4 items is rated on a 5-point Likert scale, typically ranging from 1 (Completely Disagree) to 5 (Completely Agree). Average Item Rating: To find the average for a specific item, sum the scores from all respondents and divide by the total number of respondents. Aggregate Score: To calculate the overall IAM score for an individual or group, take the mean (average) of the four items. Interpretation: Higher average scores indicate that stakeholders perceive the intervention as more appropriate, fitting, or relevant to their specific setting or population.	Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
Implementation Science Sustainability Survey Measures: FIM	FIM: The Functional Independence Measure (FIM) is a standardized assessment tool used primarily in rehabilitation to measure a patient's level of disability and the amount of assistance they require for daily activities. Item Scale: Each of the 4 items is rated on a 5-point Likert scale, typically ranging from 1 (Completely Disagree) to 5 (Completely Agree). Final Score: Sum the scores of all 4 items and divide by 4 to get the individual respondent's mean score. Interpretation: Higher scores (closer to 5) indicate that the intervention is perceived as more feasible, "doable," or "possible". There are currently no established "cut-off" scores; results are typically compared across different time points or groups.	Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
Implementation Science Sustainability Survey Measures: SUS	SUS: The system Usability Scale is a 10-item measure of digital intervention usability. Items are scored on a 5-item Likert scale (Strongly Disagree-Strongly Agree). Convert these raw ratings into a "score contribution" for each item: Odd-numbered items (1, 3, 5, 7, 9): Subtract 1 from the raw user response (i.e. X-1) Even-numbered items (2, 4, 6, 8, 10): Subtract the raw user response from 5 (i.e. 5-X) Result: Every item will now have a value between 0 and 4. Aggregate Calculation: Sum the Scores: Add all 10 converted item scores together. This will result in a total between 0 and 40. Then multiply this sum by 2.5. This step scales the total from a 40-point maximum to a 100-point maximum. Interpretation of Results: The final SUS score is a measure of perceived usability, not a percentage. Generally, the following benchmarks apply: Score < 51: Often considered "poor" or "unaccepta	Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
Household Food Security Survey Module - 10 item (Adult Only)	The Household Food Security Survey Module (HFSSM) is the primary, validated survey tool used to measure the prevalence and severity of food insecurity in the United States and other countries like Canada. The Household Food Security Survey Module (HFSSM) is scored by calculating a raw score based on the number of affirmative responses to its questions. This raw score is then used to classify households into specific food security categories. 0 affirmative responses = High Food Security 1-2 affirmative responses = Marginal Food Security 3-5 affirmative responses = Low Food Security 6-10 affirmative responses = Very Low Food Security	Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Session Rating Scale	The 4-item Session Rating Scale is a therapeutic practice measure that treatment recipients complete after receiving treatment. This allows trained helpers to make real-time adjustments to improve treatment effectiveness and prevent dropout. Participants marked their responses on a Likert-Scale, ranging from 0 to 10, representing: (a) the quality of the therapeutic relationship, (b) agreement on goals and topics, (c) the relevance and fit of the treatment provider's approach, and (d) the overall effectiveness of the treatment dosage. The scores for each domain were summed to generate a total possible score of 40. A total score below 36 or a score below 9 on any single item is a potential indicator of concern, which should prompt the therapist to discuss the issue openly with the client and make necessary adjustments to the session's direction or approach.	Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
Consolidated Framework for Implementation Science (CFIR) Interview Guide Tool	The Consolidated Framework for Implementation Research (CFIR) Interview Guide Tool is an online, interactive resource that helps users build a customized semi-structured interview guide based on the five domains and associated constructs of the CFIR. This tool does not produce a single "score" like a standard survey. Instead, it is a qualitative tool used to identify determinants (barriers and facilitators) that are then rated using a specific valence and magnitude system.	Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Virginia Polytechnic Institute and State University; Georgia State University; University of Louisiana at Lafayette

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2025
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): August 30, 2030

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Older adults; Suicidality; Intervention trial; Home Bound Meals; warm-calling
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Behavior; Personal Satisfaction; Social Behavior; Suicidal Ideation; Depression; Psychological Well-Being; Social Adjustment
• Other Study ID Numbers: IRB202501649; 90INNU0058-01-00 (Other Grant/Funding Number: Administration for Community Living (ACL))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No