About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.)
Disqualifiers
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
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
Trial design
Parallel
Treatments tested in this trial
Standardized and manualized warm calls from providers trained in the BE training
BehavioralWeekly 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
BehavioralWeekly call dosages averaging 20-30 minutes each, for 8 weeks duration; with a 6 month follow up.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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).
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.
Secondary outcomes
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.
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.
Sponsors and contacts
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University of Florida
Lead sponsor
University of Louisiana at Lafayette
Collaborator
Virginia Polytechnic Institute and State University
Collaborator
Georgia State University
Collaborator