Equipping the Aging Network to Address Social Isolation, Loneliness, and Elevated Suicide Risk Among Vulnerable Older Adults: A Partially Nested Randomized Controlled Trial of the BE WITH Innovation
Phase: NA
Conditions: Older Adults, Mental Health, Depression, Loneliness, Social Isolation, Suicide Ideations, Social Functioning, Quality of Life, Thwarted Belongingness, Perceived Burdensomeness, Help-Seeking Behavior, Suicide Risk
Sponsor: University of Florida

Addressing social isolation, loneliness, and elevated suicide risk among vulnerable 
older adults through an 8-week caring contacts treatment:  
A partially nested randomized controlled trial 
 
NCT07204444 
 
June 23, 2025 
 
 
 

Based on the NIH Protocol Template for Behavioral and Social Sciences Research Involving 
Humans 
ADDRESSING SOCIAL ISOLATION, 
LONELINESS, AND ELEVATED SUICIDE RISK 
AMONG VULNERABLE OLDER ADULTS 
THROUGH AN 8 WEEK CARING CONTACTS 
TREATMENT:  
A PARTIALLY NESTED RANDOMIZED 
CONTROLLED TRIAL 
 
Protocol Number*: 1 
National Clinical Trial (NCT) Identified Number:  <Number, once assigned 
by CT.gov> 
Principal Investigator*: Laura Shannonhouse 
Sponsor: U.S. Department of Health and Human Services 
Grant Title: Equipping the aging network to address social isolation, 
loneliness, and elevated suicide risk among vulnerable older adults during 
COVID-19 and beyond: A partially nested randomized controlled trial 
Grant Number*: 90INNU0021-03-00 
Funded by: Administration for Community Living; U.S. Department of 
Health and Human Services 
Version Number:  1 
 
 
 
 

Based on the NIH Protocol Template for Behavioral and Social Sciences Research Involving 
Humans 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the NIH 
terms of award. 

BE WITH PN-RCT 
 
Protocol 1
 
 
 
Based on the NIH Protocol Template for Behavioral and Social Sciences Research Involving 
Humans 
Table of Contents 
STATEMENT OF COMPLIANCE 
1 
INVESTIGATOR’S SIGNATURE 
1 
1 
PROTOCOL SUMMARY 
2 
1.1 
Synopsis 
2 
1.2 
Schema 
3 
1.3 
Schedule of Activities 
5 
2 
INTRODUCTION 
5 
2.1 
Study Rationale 
5 
2.2 
Background 
5 
2.3 
Risk/Benefit Assessment 
6 
2.3.1 
Known Potential Risks 
6 
2.3.2 
Known Potential Benefits 
7 
2.3.3 
Assessment of Potential Risks and Benefits 
7 
3 
OBJECTIVES AND ENDPOINTS 
7 
4 
STUDY DESIGN 
8 
4.1 
Overall Design 
8 
4.2 
Scientific Rationale for Study Design 
10 
4.3 
Justification for Intervention 
11 
4.4 
End-of-Study Definition 
11 
5 
STUDY POPULATION 
12 
5.1 
Inclusion Criteria 
12 
5.2 
Exclusion Criteria 
12 
5.3 
Lifestyle Considerations 
13 
5.4 
Screen Failures 
13 
5.5 
Strategies for Recruitment and Retention 
13 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
15 
6.1 
Study Intervention(s) or Experimental Manipulation(s) Administration 
15 
6.1.1 
Study Intervention or Experimental Manipulation Description 
15 
6.1.2 
Administration and/or Dosing 
16 
6.2 
Fidelity 
16 
6.2.1 
Interventionist Training and Tracking 
16 
6.3 
Measures to Minimize Bias: Randomization and Blinding 
18 
6.4 
Study Intervention/Experimental Manipulation Adherence 
18 
6.5 
Concomitant Therapy 
19 
6.5.1 
Rescue Therapy 
19 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
19 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation 
19 
7.2 
Participant Discontinuation/Withdrawal from the Study 
19 
7.3 
20w-Up 
20 
8 
STUDY ASSESSMENTS AND PROCEDURES 
20 
8.1 
Endpoint and Other Non-Safety Assessments 
20 
8.2 
Safety Assessments 
23 
8.3 
Adverse Events and Serious Adverse Events 
24 
8.3.1 
Definition of Adverse Events 
24 

BE WITH PN-RCT 
 
Protocol 1
 
 
 
Based on the NIH Protocol Template for Behavioral and Social Sciences Research Involving 
Humans 
8.3.2 
Definition of Serious Adverse Events 
24 
8.3.3 
Classification of an Adverse Event 
24 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up 
25 
8.3.5 
Adverse Event Reporting 
25 
8.3.6 
Serious Adverse Event Reporting 
25 
8.3.7 
Reporting Events to Participants 
25 
8.3.8 
Events of Special Interest 
26 
8.3.9 
Reporting of Pregnancy 
26 
8.4 
Unanticipated Problems 
26 
8.4.1 
Definition of Unanticipated Problems 
26 
8.4.2 
Unanticipated Problems Reporting 
26 
8.4.3 
Reporting Unanticipated Problems to Participants 
27 
9 
STATISTICAL CONSIDERATIONS 
27 
9.1 
Statistical Hypotheses 
27 
9.2 
Sample Size Determination 
27 
9.3 
Populations for Analyses 
27 
9.4 
Statistical Analyses 
28 
9.4.1 
General Approach 
28 
9.4.2 
Analysis of the Primary Endpoint(s) 
28 
9.4.3 
Analysis of the Secondary Endpoint(s) 
28 
9.4.4 
Safety Analyses 
28 
9.4.5 
Baseline Descriptive Statistics 
29 
9.4.6 
Planned Interim Analyses 
29 
9.4.7 
Sub-Group Analyses 
29 
9.4.8 
Tabulation of Individual Participant Data 
29 
9.4.9 
Exploratory Analyses 
30 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
30 
10.1 
Regulatory, Ethical, and Study Oversight Considerations 
30 
10.1.1 
Informed Consent Process 
30 
10.1.2 
Study Discontinuation and Closure 
32 
10.1.3 
Confidentiality and Privacy 
33 
10.1.4 
Future Use of Stored Specimens and Data 
33 
10.1.5 
Key Roles and Study Governance 
33 
10.1.6 
Safety Oversight 
33 
10.1.7 
Clinical Monitoring 
34 
10.1.8 
Quality Assurance and Quality Control 
34 
10.1.9 
Data Handling and Record Keeping 
35 
10.1.10 
Protocol Deviations 
35 
10.1.11 
Publication and Data Sharing Policy 
35 
10.1.12 
Conflict of Interest Policy 
36 
10.2 
Additional Considerations 
36 
10.3 
Abbreviations and Special Terms 
36 
10.4 
Protocol Amendment History 
37 
11 
REFERENCES 
37 

BE WITH PN-RCT 
 
Protocol 1
 
 
 
Based on the NIH Protocol Template for Behavioral and Social Sciences Research 
 
1 
1. STATEMENT OF COMPLIANCE 
This PN-RCT will be conducted in compliance with the International Council on Harmonisation Good 
Clinical Practice (ICH GCP) applicable United States (US) Code of Federal Regulations (CFR), and the 
U.S. Department of Health and Human Services’ Terms and Conditions of Award. The Principal 
Investigator will assure that no deviation from, or changes to the protocol will take place without prior 
agreement from the funding agency and documented approval from the Institutional Review Board (IRB), 
and the Investigational new behavioral health treatment (BE WITH), if applicable, except where 
necessary to eliminate any immediate hazard(s) to the trial participants.  
All personnel involved in the conducting of this study will have completed CITI training.  
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) will 
be obtained before any participant is consented. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form(s) 
will be IRB approved; a determination will be made regarding whether a new consent needs to be 
obtained from participants who provided consent, using a previously approved consent form. 
2. 
INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances that 
this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
Signed: 
Date: 
 
 
         Name: Laura Shannonhouse 
 
         Title: Associate Professor 
 
         Affiliation: University of Florida 
 
         Address: 1221 SW 5th Ave Gainesville, FL 32601 
 
         Telephone: 352.359.0950 
 
         Email: lshannonhouse@coe.ufl.edu 
 
Investigator Contact Information 
[For multi-site studies, the protocol should be signed by the clinical site investigator who is responsible 
for the day to day study implementation at his/her specific clinical site.] 
Signed: 
 
Date: 
 
 
         Name:  
 
         Title:  
 
         Affiliation:  

BE WITH PN-RCT 
 
Protocol 1
 
 
 
Based on the NIH Protocol Template for Behavioral and Social Sciences Research 
 
2 
1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
ADDRESSING SOCIAL ISOLATION, LONELINESS, AND 
ELEVATED SUICIDE RISK AMONG VULNERABLE 
OLDER ADULTS THROUGH AN 8 WEEK CARING 
CONTACTS TREATMENT: A PARTIALLY NESTED 
RANDOMIZED CONTROLLED TRIAL 
 
Grant Number: 
90INNU0021-03-00 
Study Description: 
This PN-RCT evaluates an 8-week caring contacts treatment that is 
delivered to older adults (urban racially diverse, suburban, and/or rural) 
in 20-30 minute warm calling "dosages", over 3 conditions. 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), 
and treatment provided by helpers trained in BE plus a standardized, 
manualized, and evidence-based suicide intervention training, the Aging 
Variant of LivingWorks ASIST (BE WITH), and 1 control (no 
treatment). Hypotheses include: (a) participants in the BE and BE 
WITH treatment conditions will experience significantly more 
improvement across measures than those in the control condition over 
the course of the 8-week treatment and (b) outcome improvements for 
those in treatment conditions will be more pronounced for those who 
begin the period at greater risk. 
Objectives*: 
 
 
Primary Objective: To develop BE WITH Innovation and equip the 
Aging Services Network (ASN) with proven skills to reduce social 
isolation, loneliness, and elevated suicidality and promote social 
support/well-being with older adults receiving nutrition services. 
Secondary Objectives: To validate and replicate BE WITH 
Endpoints*: 
 
Primary Endpoint: Reduction in social isolation, loneliness, and 
elevated suicidality and improved social support/well-being for older 
adult participants receiving nutrition services.   
Secondary Endpoints: Improved frequency of empathic and suicide 
intervention best practice behaviors by trained volunteers  
Study Population: 
 
Target n = 540 to adequately power the PN-RCT; men and women, 
aged 65 or older, receiving nutrition services, without instance of 
dementia or cognitive impairment, and in the state in the Southeastern 
US. 
 
Description of 
Sites/Facilities Enrolling 
Participants: 
There will be three Area Agencies on Aging, and 25 senior centers that 
will be involved in this clinical trial. 

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Protocol 1
 
 
 
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Description of Study 
Intervention/Experimenta
l Manipulation: 
 
The 8-week warm calling treatment is delivered to older adults in 20-30 
minutes, once a week by phone call, over three conditions: BE, BE 
WITH, and control. The BE condition involves receiving services from 
providers trained to foster belongingness and empathy. The BE WITH 
condition includes the BE training as well as the aging variant of 
LivingWorks ASIST (Applied Suicide Intervention Skills Training).  
 
Study Duration*: 
24 months 
 
Participant Duration: 
 
2 months 
1.2 
SCHEMA  
 
Example #1 Flow Diagram (e.g., randomized controlled trial) 
 
 
Administer study intervention Session 2 
Dose 2 
D
 
Administer study intervention Session 3 
Dose 3 
 
Total N: 540 
Pre-screen potential participants by inclusion and exclusion criteria 
Pre-screening  
Day -7 to Day 7 
Conduct informed consent process. Perform baseline assessments. 
 
 
BE WITH 
N = 180 
BE 
N = 180  
 
Administer study intervention Session 1 
Dose 1 
Day 14 
Randomize 
 
SILES 1 
Intervention 1 
D
21 ± 7
Control 
N = 180  

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Protocol 1
 
 
 
Based on the NIH Protocol Template for Behavioral and Social Sciences Research 
 
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Administer study intervention Session 4
Dose 4 
Day 35 
 
SILES 2 
Intervention 2 
Da 35 ± 7
 
Administer study intervention Session 5 
Dose 5 
Day 42 
 
Administer study intervention Session 6 
Dose 6 
Day 49 
 
SILES 3 
Intervention 3 
Day 49  ± 7 
 
Administer study intervention Session 7 
Dose 7 
Day 56 
 
Administer study intervention Session 8 
Dose 8 
Day 63
 
SILES 4 
Intervention 4 
Day 63 ± 7

BE WITH PN-RCT 
 
Protocol 1
 
 
 
Based on the NIH Protocol Template for Behavioral and Social Sciences Research 
 
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1.3 
SCHEDULE OF ACTIVITIES  
 
 
3. 
2        INTRODUCTION 
1. 
2.1     STUDY RATIONALE  
 
Social isolation and loneliness are prevalent among older adults,1 detrimental to their health 
and  well-being,1,2,3 and can lead to suicide.4 While 24% of community-dwelling older adults in the 
United  States are socially isolated, almost half of older adults report feeling lonely.5,6 Loneliness and 
social isolation have deleterious effects on older adults’ physical and mental health7, including 
elevated risk of  dementia,8 hopelessness,9anxiety,10 and increased morbidity.11-12 When older adults 
feel like they do not belong (thwarted belongingness), and that they are a burden to others (perceived 
burdensomeness), desire for suicide increases.13 An older adult dies by suicide every 65 minutes.14 
Yet these data only reflect  officially reported suicides; many more are categorized incorrectly and/or 
go unreported (e.g., overdose, voluntary stopping of eating and drinking, withholding medical 
treatment15). Social isolation, loneliness, and elevated suicidality (SILES) were exacerbated by the 
COVID-19 pandemic.16-19 In addition to elevated physical health risks,20,21 older adults face 
deleterious psychological and social impacts from the disease.22 Social support is one of the strongest 
predictors of  positive psychological outcomes during disaster.22,24  
 
2. 
2.2     BACKGROUND  
 
Applied Suicide Intervention Skills Training (ASIST), a standardized, manualized,  
 
Week 
0 
Week 
1 
Week 
2 
Week 
3 
Week 
4 
Week 
5 
Week 
6 
Week 
7 
Week 
8 
Week 
9 
MOUs with AAAs 
and senior centers 
X 
 
 
 
 
 
 
 
 
 
Secure Lists of 
Potential 
Participants From 
Senior Centers 
X 
 
 
 
 
 
 
 
 
 
Recruitment Phone 
Calls 
 
X 
 
 
 
 
 
 
 
 
Baseline Survey 
 
X 
 
 
 
 
 
 
 
 
Scoring of Baseline 
Survey 
 
X 
 
 
 
 
 
 
 
 
Random Assignment 
to 3 Conditions 
 
X 
 
 
 
 
 
 
 
 
Phone Calls Back to 
Participants with 
Corresponding 
Consent (BE, BE 
WITH, Control) 
 
X 
 
 
 
 
 
 
 
 
Measurement 
Occasions 
 
 
 
X 
 
X 
 
X 
 
X 
Call Dosages 
 
 
X 
X 
X 
X 
X 
X 
X 
X 

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Protocol 1
 
 
 
Based on the NIH Protocol Template for Behavioral and Social Sciences Research 
 
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internationally recognized training developed by LivingWorks, has been adopted by the U.S. Armed  
Forces,55 and the Centers for Disease Control.15 Grounded in a public health framework, ASIST 
prepares natural helpers to facilitate life-assisting interventions at the moment needed.36,56 ASIST is the 
only evidence-based intervention training that has been found to reduce suicidality in real time.57-59 
Emphasis  is placed on the “quality of the interaction between the natural helper and the person-at-
risk,”15 with a  focus on how that connection can reduce risk while connecting the person with 
resources. ASIST-trained helpers learn to address a variety of emotional disturbances,60 and its 
intervention model (i.e., pathway for assisting life) can be generalized to work with additional 
challenges such as social isolation and loneliness. In some instances, ASIST has been found sufficient 
to keep the person-at-risk safe, with no further need for dedicated mental health services.51 ASIST-
saturated hospitals,61 school systems,62 and military contexts55 have reported reduced suicides, more 
brief interventions, and fewer referrals to other services. ASIST is appealing to the ASN, as it is not 
likely to increase the need for coordinating official mental health treatment as older adults are getting 
needs met in real time.  
ASIST equips volunteers with intervention skills that keep them from feeling “immobilized” 
and unsure of how to help when they feel something is wrong with their older adult clients, which may 
prevent burnout. ASIST trained nutritional service (NS) volunteers are ready, willing, and able to ask 
directly about suicide, understand the stressors in client’s life, work effectively with ambivalence about 
dying, identify reasons for living, and create a mutually agreed upon safe plan46 (see Appendix C). In 
spite of its merits, ASIST was not developed with older adults in mind, and outcomes have not yet been 
rigorously evaluated in the ASN context. Similar to the augmented version of ASIST for the military, 
LivingWorks has agreed to work with us to adopt a new aging specific variant of ASIST (see letter of 
support). Modifications include video scenes of warning signs in older adults (i.e., voluntary stopping 
of eating and drinking), understanding thwarted belongingness and perceived burdensomeness in later 
life, and role plays relevant to working in the nutrition context. Trained NS volunteers will be able to 
identify and respond to the unique situations they may face during HDM, and now in other socially 
distanced communications with older adults.   
Phone-based Belonging through Empathy (BE) Training will be a brief, online module to 
guide NS volunteers in how to foster a sense of belonging for older adults through empathic, engaged  
listening (see Appendix B). Concrete tips are provided for ensuring calls are conducted in a manner that 
fosters relationships -- putting natural helpers into the lives of older adults. People who are connected 
and feel understood are at less risk for suicide than those who are isolated. Belonging is a powerful 
reason for  living among older adults,63 and its absence is a proven risk factor for suicide.12 Empathy 
consists of  genuinely engaging, recalling details from previous conversations, and maintaining 
composure and care  when painful material is identified.28 Developments in biology and neuroscience 
routinely show that  empathy is a core building block of human connection,64-65 making it an essential 
skill for volunteers to  develop and employ when speaking with older adults. By equipping NS 
volunteers to promote a sense of belonging through empathic techniques such as active listening, 
building trust, and communicating a sense of mattering, we aim to reduce social isolation, loneliness, and 
elevated suicidality for HDM recipients and former CM clients.   
 
3. 
2.3     RISK/BENEFIT ASSESSMENT  
1. 
2.3.1  KNOWN POTENTIAL RISKS  
 
In the short term, there is the possibility that participation in this project may cause older adult participants 
to feel some worry or concern - for example, they may be asked about how they have been coping, and this 
may bring up feelings of anxiety. However, research has shown that talking about stressful life events 
provides opportunities to receive support and actually reduce stress. If participants experience any concerns, 

BE WITH PN-RCT 
 
Protocol 1
 
 
 
Based on the NIH Protocol Template for Behavioral and Social Sciences Research 
 
7 
the informed content specifies that study personnel are available to answer any questions they may have 
and to provide support.  Another known risk is the possibility of the participants feeling a sense of loss once 
the study is over as they will have built relationships with their calling providers.  
 
In the long term, there are no risks affiliated with participation in this study. 
 
2. 
2.3.2  KNOWN POTENTIAL BENEFITS  
 
Immediate potential benefits: Social support has been proven across hundreds of behavioral health studies 
to be one of the strongest predictors of positive psychological outcomes following disaster.  Research has 
also shown that connecting with others during crisis, disaster (i.e. pandemic) is helpful in the immediate. 
Across disasters talking about, expressing, and feeling one’s feelings has been found to set persons apart 
from those that do not in terms of faring better as a result of experiencing crisis/disaster39.  
 
Long term potential benefits: Overall, we hope to gain information about the BE WITH innovation, and 
ideally submit BEWITH to be accepted on the National Council on Aging’s (NCOA) evidence-based 
registry to enable warm calling programs to occur across the US. Currently, there is no program to make 
warm calls, or visits remotely on the NCOA registry, so the older adult participants in this study will be 
made aware (in the informed consent) of this larger purpose and that they are helping contribute to bringing 
these types of warm calling programs to older adults across the country.  
 
3. 
2.3.3  ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
Older adults are the highest risk age cohort for suicide however the least likely to receive intervention. 
Creating an opportunity to receive an 8-week caring contacts intervention may be a standardized and 
measurable means of catching those at risk and responding to them in real time. While any risk to 
participants for participation is deemed extremely low, assessment questions might create some feelings 
of discomfort. Providing the assessment questions is a necessity for tracking mental health variables 
(including suicidality) as well as being able to measure the impact of the treatment across conditions.  
The value of the information gained outweighs any risk of participation. Older adults at risk will receive 8 
weeks of standardized and manualized warm calls, potentially with intervention if at risk of suicide, and 
the knowledge learned will enable us to get this treatment on NCOA’s evidence-based registry. This will 
enable AAA’s (Area Agencies on Aging) and senior centers throughout the country to use Title 3D 
dollars to put this program into their contexts to respond to older adults experiencing mental health 
distress and better respond to the problem of suicide in this population.  
 
4. 
3     OBJECTIVES AND ENDPOINTS  
 
Objective 
Metric/Variable 
Hypothesis/role/endpoint 
Analysis 

BE WITH PN-RCT 
 
Protocol 1
 
 
 
Based on the NIH Protocol Template for Behavioral and Social Sciences Research 
 
8 
Validate the  
BE WITH 
innovation  
 
Reduce loneliness, 
and elevated 
suicidality, and 
increase the degree 
to which social 
needs are met  
Over the 8-week treatment loneliness and 
suicide desire (as measured by the UCLA 
loneliness scale, Interpersonal Needs 
Questionnaire) will be significantly 
decreased, and the variable of social needs 
being met (as measured by the social 
provisions scale) will be increased for both 
treatment groups 
Longitudinal 
growth 
modeling 
Validate the  
BE WITH 
innovation  
Three treatment 
conditions 
Those older adult participants randomly 
assigned to the BE or BE WITH treatment 
condition will demonstrate significant 
improvements in mental health outcomes 
when compared with the control group 
Longitudinal 
growth 
modeling 
Validate the  
BE WITH 
innovation  
Risk tier 
Those older adults that start the 8-week 
treatment at medium or high risk will have 
statistically significant improvements when 
compared with those of low risk 
Longitudinal 
growth 
modeling 
Validate the  
BE WITH 
innovation 
Provider effects 
Determine if there is variance in outcomes 
as a result of the provider assigned. 60 
providers were trained in either BE or BE 
WITH and carried caseloads of older adult 
clients enabling the nesting of effects to 
determine if there are individual or group 
level provider effects 
Multilevel 
modeling 
Validate the  
BE WITH 
innovation  
 
Improved quality, 
frequency of 
empathic and 
suicide intervention 
best practice 
behaviors by 
trained NS 
providers  
  
 
An augmented version of Gould’s (2013) 
coding protocol was developed to 
quantitatively behaviorally code treatment 
call dosages.   
independent 
quantitative 
behavioral 
coding, 
double 
coding, 2 
protocols, 
inter-rater 
agreement, 
coefficient 
kappas 
 
The main overarching objective of the clinical trial is to validate the 8-week BE WITH warm 
calling 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. The goal of 
the validation objective is to garner the evidence needed to get the first such program on the National 
Council on Aging’s Evidence Based Registry.  
 
5. 
4       STUDY DESIGN 
1. 
4.1    OVERALL DESIGN 
This study is a partially nested randomized controlled trial research design (PN-RCT74-77) with 
a two-level structure of clients (level-1) nested within callers (level-2) for the two treatment conditions 

BE WITH PN-RCT 
 
Protocol 1
 
 
 
Based on the NIH Protocol Template for Behavioral and Social Sciences Research 
 
9 
which receive calls. Given that outcomes for older adults receiving calls from the same volunteer may 
be more similar than for those who receive calls from a different volunteer, the use of multilevel 
modeling can account for these data dependencies.  
We will be investigating 1) how our BE WITH innovation reduces social isolation, loneliness, 
and elevated suicidality among HDM and former CM clients and improves their social support and 
well-being. Social isolation, loneliness, and elevated suicidality will be operationalized through a 
combination of validated psychometric measures taken before, during, and after the structured 8-week 
intervention. For older adults receiving calls, data from validated measures will be triangulated with 
behavioral observations of the older adults’ emotional states based upon a structured analysis of 
recorded audio files.  
  
We hypothesize that older adults in both treatment conditions will have reduced: social 
isolation, loneliness, depression, anxiety, mental health distress, and suicide desire; and they will have 
increased: social connection, social support, and well-being over time and in comparison to those in 
the control condition.   
We will also investigate 2) how BE WITH improves the frequency of empathic and suicide 
intervention best practice behaviors by NS volunteers to older adult participants that have heightened 
social isolation, loneliness, and elevated suicidality. This will be demonstrated in both real-world 
settings and in situations where a research confederate presents a clinically heightened risk of social 
isolation, loneliness, and elevated suicidality. Evaluation of counseling or suicide intervention skills is 
challenging,15 as observations of caregivers working with clients are required. 
We hypothesize that those trained in both conditions will demonstrate positive global 
counseling behaviors; however, those trained in BE WITH will more often employ suicide intervention 
practices when needed. 
 
Measured Outcome 
Sample  
Data Collection / Tracking 
Reduction in loneliness, elevated 
suicidality, and   
improved social 
support/well-being for 
older adult clients 
Validated constructs (see   
appendix D):  
  
Loneliness (UCLA); Social 
Support (SPS); Suicide -- Risk 
(SBQ-R), Suicide Desire 
(INQ), Suicide Capability 
(FAD); Depression (PHQ); 
Anxiety (GAD); Distress (K6);  
540 Clients, randomly 
assigned to 3 
conditions. This 
includes the 2 tx 
conditions and a 
control that receive 
no calls  
Stratified random   
sampling by 3 levels 
of loneliness and 
suicidality (low, 
medium, and high 
risk tiers) 
Data collection for older adult 
participants:  
· pre intervention (baseline)  
· measurement occasions every 2 
weeks (total of 5 measurement 
occasions) 
 
 

BE WITH PN-RCT 
 
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Improved frequency of 
empathic and suicide 
intervention best practice 
behaviors by NS   
volunteers  
Coded constructs:  
Adapted observation 
protocol51 ·  
 
60 Volunteers, 
randomly assigned to 
2 conditions.  
 · BE training only   
· BE WITH (BE 
training plus ASIST)   
Those trained in BE 
will be offered ASIST 
after the study. 
Preceding the intervention study, 
all volunteers receive BE (phone-
based social connection) training. 
BE WITH volunteers will be given 
the standardized and manualized 
ASIST training (if they have 
previously received ASIST, they 
will be provided with the ASIST 
refresher training).  
 
Validated outcome measures are essential for effective evaluation of any mental health or 
suicide prevention programming. While the social isolation, loneliness, and elevated suicidality 
constructs we will study are listed in the following table, the specific psychological scales that measure 
them are listed and explained in Appendix D. The comprehensive battery of assessments has been field 
tested and well received by older adults (Appendix D). We have also completed cognitive interviews70 
(administered questions and sought feedback on the experience from older adults), and trained data 
collectors to use a conversational style in speaking with participants. Short forms of several of these 
measures will be completed weekly by the older adults and take 15 minutes to complete.  
Analyses will investigate the effect of treatment conditions (BE, BE WITH, and control) on 
post-intervention outcomes (i.e. endpoints) while controlling for baseline responses (prior to 
intervention). Furthermore, analyses will explore differences between treatment conditions in 
longitudinal trends of client state as well as how volunteers utilize specific intervention skills over time. 
For this longitudinal data, a lower level of nesting will be included in the analysis: weekly call and state 
data (level 1) nested within older adults (level 2) nested within volunteers (level 3). However, the PN-
RCT design would only have levels 1 and 2 for the control group.  
 
2. 
4.2     SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
Due to increased social isolation and loneliness in older adults, experts have called for 
innovative approaches to address them, including “training nontraditional groups to provide 
psychological first aid, helping teach the lay public to check in with one another and provide 
support.”27 The aging services network (ASN) has made concerted efforts to reconfigure key programs 
to protect older adults and is prioritizing programs that can be delivered remotely. ADvancing States25 
has described how community-based organizations are launching programs intended to address social 
isolation and loneliness, with phone-based social connection identified as a promising strategy to 
engage volunteers and support at-risk older adults. In April 2020, the National Council On Aging 
(NCOA) surveyed community-based organizations about older adult clients’ needs, and 62% described 
“staying socially connected while physically distancing” as a “high priority.”26 Meanwhile, the report 
indicated due to the pandemic, the need for home-delivered meals (HDMs) increased while that for 
other programs (e.g.,  chronic disease self-management, falls prevention, caregiver support) decreased.   
In May 2020, we developed guidelines for the Administration for Community Living 
(ACL) regarding how nutrition services (NS) volunteers can foster and maintain meaningful 
connections with socially isolated older adults. That document, Enhancing Socialization through 
Making Meaningful Volunteer Connections (Appendix B), provides 15 recommendations for 
engagement in phone-based social connection. Although these programs are in early stages of 

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development within the ASN, there is evidentiary support that key skills such as active listening,28 
empathy,29 and promoting a sense of belonging30 may be vitally important. Unfortunately, no 
programs on the NCOA Evidence-Based Registry address social isolation, loneliness, and elevated 
suicidality. Our innovation seeks to remedy that.  
 
3. 
4.3      JUSTIFICATION FOR INTERVENTION 
 
Many older adults who are at-risk for social isolation, loneliness, and elevated suicidality are 
also at risk for food insecurity or institutionalization. The Older Americans Act (OAA) Nutrition 
Program that includes congregate meal (CM) and HDM is the largest and primary program within 
home and community-based services (HCBS)31, making it a strategic context to address other issues, 
such as social isolation, loneliness, and elevated suicidality, among at-risk older adults. Many 
homebound older adults have limited social  contacts,32 including 20% who have infrequent contact 
with friends or family.33 NS volunteers often form  an important part of older adults’ social support 
networks.34 In previous research, measures of loneliness  and well-being improved for older adults after 
just two months of receiving HDM services.35 Consistent  with a public health approach to prevention36, 
NS volunteers already function as natural helpers, defined  by suicide researchers as those “who 
already have close communication” with older adults either through  their “ongoing job role” or by 
“virtue of personal qualities, such as warmth and empathy.”37-41 Volunteers  from NS programs may be 
among very few individual(s) who interact on a regular basis with older adults  receiving NS. This is 
particularly relevant to supporting older adults’ mental health because depression rates are three times 
higher in older adults who require in-home care compared to community samples42, and 13.4% of 
HDM clients reported suicidal thoughts to a volunteer45. NS volunteers are vital in helping these older 
adults remain safe and in the community. 
Our team has previously established the ASN is a strategic context to address suicide risk, 
and NS volunteers are uniquely positioned to intervene due to their regular and ongoing interactions 
with older adults43, due to their pre-established relationship with them.44-45 Our previous work 
equipping NS volunteers with evidence-based skills to intervene with older adults experiencing 
suicidality is, to our knowledge, the first of its kind (ACL grant 90INNU0010-01-00). In our 
analysis we found NS volunteers  were able to learn suicide intervention skills effectively 
(significant pre to posttest changes, high effect  size) and utilize them to provide social support.46 
Furthermore, they exhibited increased comfort,  competence, and confidence about responding to 
older adults at risk of suicide.47 County leadership  reported trained volunteers were “more aware”, 
“more likely to pick up extra shifts”, and “more invested”  (see Cobb letter of support). NS 
volunteers demonstrated increased awareness of older adult mental health  needs, and were better 
equipped to respond to suicide risk.50 Although this training was only in one system for a limited 
time, more than 30 interventions were tracked,  including some over the phone.50 These findings 
provide a proof of concept for having NS volunteers address social isolation, loneliness, and 
elevated suicidality alongside their role in delivering meals, and that additional investigation of such 
trainings  could well demonstrate the outcomes with older adults required for eligibility on the 
NCOA registry.  
 
4. 
4.4     END-OF-STUDY DEFINITION 
 
A participant is considered to have completed the study if he or she has completed the baseline 
assessment, 4 additional measurement occasions evaluating the treatment (8 weeks of treatment call 
dosages). 

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6. 
5        STUDY POPULATION 
1. 
5.1     INCLUSION CRITERIA 
 
In order to be eligible to be 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 nutrition services through the Aging Services Network (i.e. either HDM (home delivered 
meals services) or CM (congregate meals)) 
5. Be affiliated with one of the 25 senior centers we will contract with through a Memorandum of 
Understanding 
 
In order to be eligible to be a trained helper 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 25 
senior centers we are working with 
4. Meet 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 senior center leadership as meeting these qualifications 
 
2. 
5.2      EXCLUSION CRITERIA 
 
Exclusion criteria for Participants: An individual who meets any of the following criteria will be 
excluded from participation in this study: 
 
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 in this state 
 
The reasons given to exclude participants with dementia/cognitive impairment diagnoses from large-scale 
clinical research are partially related to the concern of a potential risk of abuse and exploitation. Further, 
those with cognitive impairment are not able to give informed consent, and there are measurement 
challenges with behavioral health data.  
 
Exclusion criteria for trained natural helpers: An individual who meets any of the following criteria will 
be excluded from participation in this study: 
 

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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 in this state 
 
3. 
5.3      LIFESTYLE CONSIDERATIONS 
N/A  
 
4. 
5.4      SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently randomized and assigned to one of the 3 treatment conditions. Individuals who do not meet 
the criteria for participation in this trial (screen failure) because of meeting one or more exclusion criteria 
(i.e. cognitive impairment) will be removed from the study.  
 
If participants drop out between being consented, randomized, and assigned, they will have the 
opportunity to be rescreened and join a subsequent wave of treatment.   
 
5. 
5.5      STRATEGIES FOR RECRUITMENT AND RETENTION 
 
 
To adequately power the PN-RCT we need 540 participants. We plan to recruit and screen three 
times that number, and enroll a minimum of 200 more, to account for potential attrition issues.   
 
Recruitment strategies include the following: 
1. Flyers to be provided to older adults receiving HDM through their home delivered meal 
provider along with their meal  
2. Announcements of the study opportunity to be received by older adults through their case 
managers 
3. After 1 and 2, graduate research students will make personalized calls to the older adults 
to go over the recruitment script and study procedures.  
 
Sample information to be provided to older adults:  
 
  
You are invited to take part in a research study.  It is up to you to decide if you would like to take 
part in the study. The purpose of the study is to investigate the BE WITH innovation. You are invited to 
participate because you are a recipient of HDM services in X county. A total of 540 older adult clients 
receiving HDM will be included in the study. If you choose to participate, you will take a survey that will 
determine your eligibility, and you will be compensated for your time to take this survey. Your role in the 
study will take place over an 8-week period. Depending on your randomly assigned group, this time may 
be spent talking on the phone, and/or answering a short survey. The risks of being in this study include 
potentially having more worry or anxiety. This study is designed to benefit you, as the BE WITH program 
is designed to give more interpersonal connections to older persons. Overall, we hope to gain information 
about how nutrition services can provide more support to older adult clients. 

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The purpose of the study is to investigate the BE WITH training for nutrition service volunteers 
and understand how it impacts the wellbeing of nutrition service clients. You are invited to take part in 
this research study because you are, or have recently been, a nutrition service client. A total of 60 
volunteers will be invited to take part in this study along with up to 540 older adults. 
 
If you decide to take part, you will talk to a student at GSU by phone who will ask you some 
questions in a survey. You will receive $20 for taking this survey. Based on that survey, if you meet 
criteria for the program, we will contact you, and you will be assigned to either a study group or a 
control group. If you are assigned to the study group, you will be called by a volunteer once per week for 
8 weeks, and using an audio feature on teleconferencing software, both you and the volunteer will be 
recorded. However, all identifying information will be removed from the recordings. During this project, 
you may receive a call from a number you do not recognize. This will be the software we are using to 
connect you with volunteers, and to keep both of your identities safe. Once the call is recorded, no one 
will be able to connect your name or number to the recording. All involvement with this project will be 
done remotely, therefore you can participate from your home. All participants who enroll in the program 
are asked to spend 15-20 minutes completing a survey every other week over the phone. 
 
Researchers will remove information that may identify you and may use your data for future 
research. If we do this, we will not ask for any additional consent from you. 
 
There is the possibility that participation in this project may cause you to feel some worry or 
concern - for example, the volunteer may ask you about how you’re coping as they talk with you, and this 
may bring up feelings of anxiety. However, research has shown that by talking about things that are on 
our mind we feel better. If you experience any concern, we are available to answer any questions you may 
have and to provide support. No injury is expected from this study, but if you believe you have been 
harmed, contact the research team as soon as possible. Georgia State University and the research team 
have not set aside funds to compensate for any injury. Overall, we expect the risk of participation will be 
low/minimum. 
 
Participation in this study may benefit you personally. Research has shown that connecting with 
others during crisis, disaster, and pandemic is helpful. Overall, we hope to gain information about the BE 
WITH innovation, and ideally submit BE WITH to be accepted on the National Council on Aging’s 
(NCOA) evidence-based registry to enable warm calling programs to occur across the US. Currently, 
there is no program to make warm calls, or visits remotely on the NCOA registry, so you are helping us 
make that happen. 
 
The alternative to taking part in this study is to not take part in the study. 
 
If you choose to participate, and do not meet eligibility criteria, you will be provided $20 dollars 
for taking the baseline survey and your involvement will be complete at that time. If you do meet criteria 
to be enrolled in the BE WITH program, based on your assigned group, you will be required to take part 
in weekly phone calls and/or complete a survey every other week. If you are eligible and choose to 
participate, you will be mailed $20 cash at the start of the 8 weeks, and $80 in cash after you complete 
the eight-week program. This means that you are entitled to $100 total if you complete the eight-week 
program. 
Your participation is voluntary. You do not have to be involved in this project. If you decide to be 
in the study and then change your mind, you have the right to drop out at any time. You may stop 
participating at any time. If you stop participating, this will not cause you to lose any compensation you 
have already received, but you will not receive any future payments. 
We will keep your records private to the extent allowed by law. The following people will have 
access to any information that you provide: 
● Dr. Shannonhouse  
● GSU Institutional Review Board 
● GSU Office for Human Research Protection (OHRP) 
● The Administration for Community Living (part of the Federal Department of Health and 
Human Services) 

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We will use a code generated from a combination of your initials and county to de-identify you on 
project records to protect your confidentiality. The information gathered from the calls will be stored on 
a password-protected and firewall-protected computer. The key that holds your code will be stored 
separately from the data to protect your privacy. The audio recordings and any transcripts will be 
destroyed within 2 years along with the code key information. Since any information that is sent over the 
internet may not be secure, we are only using data encrypted protocols and are not logging IP addresses. 
Also, only one supervising staff member at the Southern Georgia Regional Commission will know that 
you have elected to participate. That person will not have any access to your phone recordings or surveys 
and will not even know which group you have been assigned to. 
Contact Dr. Laura Shannonhouse at 352.359.0950 or lshannonhouse@coe.ufl.edu 
● If you have questions about the study or your part in it 
● If you have questions, concerns, or complaints about the study 
We will give you a copy of this consent form to keep. 
 
7. 
6        STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
 
1. 
6.1 
 
 
 
 
STUDY 
INTERVENTION(S) 
OR 
EXPERIMENTAL 
MANIPULATION(S) ADMINISTRATION 
 
1. 
6.1.1 STUDY 
INTERVENTION 
OR 
EXPERIMENTAL 
MANIPULATION DESCRIPTION 
 
  
The BE WITH program is grounded in (1) the Befriending and Narrative Reminiscence literature 
which are best practices in working with older adults, and (2) the Interpersonal Psychological Theory of 
Suicide (ITPS)33,34. BE WITH includes an 8-week warm calling treatment that is delivered to older adults 
(racially and economically diverse, urban, suburban, and/or rural). At the start of the program, older 
adults are asked to reminisce about their life, and provide the treatment provider some information that 
can be built upon in subsequent call dosages (see graphic below).   
 
Each week an older adult participant will receive a 20-30 minute "call dosage" from treatment providers 
that are trained in 1 of 2 protocols: 
  
(a) 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 
will also be individuals who need more than connection, but rather targeted intervention as approximately 
20% of older adults receiving home and community-based services are at risk of suicide38.  
  
(b) BE WITH 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 one is needed.  

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(c) control group includes no treatment, or call dosages. Every two weeks graduate research students 
administer the measureset, just as they did for the 2 treatment conditions.   
 
 The same time intervals of outcome measures are administered across all 3 conditions.  
 
2. 
6.1.2 ADMINISTRATION AND/OR DOSING 
 
 
Sixty trained providers (30 in each treatment condition) will provide the treatment to an assigned 
caseload of older adults via the phone. We are working with software developers (i.e. Friendlybuzz) who 
built a system to automatically record the audio files of the treatment dosages. Research team members 
will populate the caseloads of the older adult clients into Friendlybuzz for the treatment providers which 
enables the older adults contact information to remain protected (a requirement of our community 
partners). After caseloads are populated, treatment providers will call into the Friendlybuzz system; 
treatment providers push “1” for their first older adult, “2” for their second, and so on through their 
caseloads of 5-7 older adults each.   
  
Treatment providers will not have any interaction with the older adults outside of providing the 
treatment.  Every two weeks, after two call dosages (20-30 minutes each), data will be independently 
collected from the participants from trained graduate students at Georgia State University. This will go on 
for an additional 3 measurement occasions, for a total of 4 measurement occasions + the baseline (see 
graphic below).   
  
Complete participation includes eight full call dosages between the average of 20-30 minutes 
each. Please see the graphic below for the complete treatment and assessment schedule.  
8. 
 
 
1. 
6.2      FIDELITY 
 

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1. 
6.2.1 INTERVENTIONIST 
TRAINING 
AND 
TRACKING 
 
The five core components to the BE training include: 
 
1. reciprocity: the feeling that both parties are benefiting 
2. intimacy: willingness to share deeply (superficial sharing at first helps build the relationship, but 
deeper sharing is what leads to positive outcomes) 
3. reliability & respect (calling at the time you say you are going to call creates consistency and 
reliability, and that the older adult matters 
4. proximity: feeling more connected to people within your community 
5. autonomy: feeling both parties are willingly participating with each connection 
 
  
Analogous to CPR (lay providers equipped to help someone that is drowning), anyone can learn 
“suicide first aid”, or LivingWorks ASIST. Persons trained in ASIST connect directly with the older adult 
at risk through a six-step model called the Pathway for Assisting Life (PAL). The PAL model matches six 
needs of the older adult-at-risk with six tasks of the caregiver.  
            Persons-at-risk (and helpers) often perceive only two options: (a) to die by suicide, or (b) to live. 
Choosing to live or die can be a tough choice when an individual is struggling with suicidality. The 
ASIST training introduces a third option, which is to stay safe for now. Through engaging the PAL model 
those trained help the patient-at-risk identify ambivalence about dying, confusion, and even reasons for 
living. This is a little miracle that saves lives, as it removes the dichotomy of life/death, and ASIST 
training equips lay providers to do this. Caregivers are not taking away the choice to suicide, and the 
person’s autonomy. Rather, through the intervention, caregivers return autonomy to persons-at-risk by 
helping them identify their own reason(s) to live, and link that to a safety plan that puts suicide on hold 
for the moment, which may turn into staying safe in the long term. The 6 steps of the PAL include: 
  
1. Notice and explore invitations (i.e. voluntary stopping of eating and drinking, withholding 
medical treatment, withdraw, talking directly about suicide, etc.) 
2. Asking directly about suicide 
3. Not only listen, but sincerely hear the story about suicide 
4. Work effectively with ambivalence about dying, which involves listening closely for confusion, 
ambivalence, hesitancy to die by suicide as the person is sharing their story, and offering a 3rd 
option (to stay safe for right now) which is an easier choice to make, and more aligned with the 
reality that there is some hopelessness that things will never change, and offering this 3rd option 
creates space for the opportunity for some things to change 
5. Developing mutually and agreed upon safety plans 
6. Confirming actions (or asking the older adult to repeat the safety plan back to us that we have 
developed together to assess their degree of commitment to it) 
 
  
Success of the training will be evaluated through pre, post and follow up training level outcome 
measures. Further interventionists will be objectively rated by trainers and supervisors.  
 
  
The degree to which those trained adhere to the intervention will be managed with the use of the 
Friendlybuzz system. This enables the research team to track the fidelity and delivery of the intervention 
in real time. This system automatically records and transcribes each treatment dosage, while organizing 
the treatment dosages within each participant, nested within each treatment provider, along with the dates 
and duration of each of the treatment dosages. 
 
 
There will not be any changes to any groups or clusters (i.e. treatment providers’ caseloads of 
older adult participants) unless there is a challenge with a treatment provider.  If there is such a challenge, 

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we will first support the treatment provider through the weekly supervision groups.  If the challenge 
persists or in the very rare case that we have a treatment provider that can no longer provide the treatment, 
any older adult participants that are assigned to the treatment provider will be re-baselined, and re-
randomized to a new treatment provider. Again, we imagine this to be very rare.  
  
2. 
6.3     MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND 
BLINDING 
We will use weighted stratified random assignment41. After participants are baselined, we will score their 
data and assign them a risk tier (low, medium, high). Subsequently, we will randomize them to one of 3 
conditions: BE condition, BE + ASIST condition, or control.  Since the trial is being conducted in cohorts 
(waves), and to ensure the least amount of time between being baselined and starting the treatment, 
participants will be randomized one by one after they are baselined. The weighted component enables 
there to be equal representation of both risk tier and number of participants across all 3 treatment 
conditions within the confines of the ongoing nature of the trial.  
At the time of baseline, participants are assigned 2 codes: one that is fully numeric, and another that is 
alphanumeric. The PI and graduate student(s) will have access to the unblinded data (i.e. both the older 
adults’ names, codes, and baseline data) as the PI is supervising the process and a few graduate students 
will be helping with scoring, and the weighted stratified random assignment.  The methodologist will only 
have access to the participants’ codes and raw data.  They will remain blind to ensure the most objective 
analysis of the data.  
If a participant remains at elevated risk for suicide at the conclusion of the treatment, we will unblind 
them and report to their assigned case manager.  
We will also use separate documents with participant codes only to track the following:  treatment 
condition, rebaselines, any survey/measurement issues, risk tiers, etc. to ensure an additional level of rigor 
in protecting against any bias. Further, in all tracking files that the PI’s research lab utilizes, only 
participant IDs will be utilized (i.e. tracking which participants are up for the next measurement occasion, 
etc.).  
The only potential inadvertent unblinding that we could foresee would be with respect to the use of the 
Friendlybuzz system. The treatment providers do need to know the first names of the older adult 
participants, therefore ONLY their first names will be available.  The data team, however, is completely 
distinct from the treatment team, and will not have access to the Friendlybuzz system.    
3. 
6.4      STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
ADHERENCE 
Participants’ adherence to the study procedures will be tracked in two ways: (1) through the Friendlybuzz 
system (tracking adherence to the treatment), and (2) through lab tracking documents (adherence to the 
measurement, data collection). The Friendlybuzz system will allow us to track in real time the call 
dosages as they are coming in, the duration of those, timing, etc. The lab tracking documents will enable 
us to know which participants need the next measurement occasion for data collection. These two 

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processes remain separate and distinct, to ensure that the treatment is distinct from the measurement of 
the treatment.  
Treatment providers are required to complete training a priori, and utilize the documents and tools (i.e. 
guidelines for making sincere connections, reminiscence table whereby there are questions provided in 
each area of the older adults life for the treatment provider to track and follow up on in subsequent 
sessions, etc.) provided to them to deliver 8 high quality treatment dosages to their caseload of older adult 
participants that are 20-30 minutes in duration each. They are required to track that, as well as attend 
weekly supervision and check in with a supervisor who is tracking their treatment delivery through the 
Friendlybuzz system.  
Participants are required to complete a “participation plan” which will be mailed to them after they are 
baselined, meet eligibility criteria and are randomized.  Those randomized to one of the two treatment 
conditions are required to participate in 8 call dosages and 4 additional measurement occasions.  Those 
randomized to the control group are required to participate in 4 additional measurement occasions and 
provided with the option to receive 8 call dosages 2 months later (delayed waitlist control).  
 
4. 
6.5      CONCOMITANT THERAPY 
N/A 
 
1. 
6.5.1  RESCUE THERAPY 
       
       N/A 
 
9. 
7       STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
1. 
7.1     DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL 
MANIPULATION 
 
Since this study involves older adults there may be death which would result in the participants’ inability 
to continue the study.  
 
2. 
7.2     PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE 
STUDY 
Participants may withdraw voluntarily from the study at any time, and/or the PI may discontinue a 
participant from the study if the participant has cognitive impairment and has somehow not been excluded 
previously. The rationale includes (a) limited/incorrect data being collected from any participant with 
cognitive impairment, and (b) may be potentially distressing to participants with cognitive impairment.  
The only reason this is included here is in the very slight chance that a participant with cognitive 

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impairment gets through the screening processes we have in place, PIs have the obligation to remove 
them from the study.   
 
We will have ongoing contacts with older adult participants throughout the 8-week study.  We anticipate 
low attrition due to weekly doses being provided by the ASN providers we train and supervise to provide 
the treatment as well as every other week data collection by trained graduate students. During supervision 
meetings with both those trained providing the treatment, as well as those collecting the data, any 
challenges will be discussed and addressed.  Data collectors have an “on call” schedule in which at all 
times there are 2 members of the PI’s lab that will be tracking data and data needs. In addition, daily 
tracking will occur by the grant coordinator who will post any missing data through de-identified 
participant ID codes in a shared GroupMe with the trained data collectors to ensure that those “on call” 
can collect that data in real time.   
 
Any participant that chose to withdraw will be supported for their choice.  We anticipate that older adults 
may have health issues, hospitalizations, and/or various other serious adverse events in their lives and we 
will ensure the tracking of these for attrition reasons.  The data to be collected at the time of study 
discontinuation will include the following: 
● The reason(s) for discontinuing the participant from the intervention (for attrition tracking) 
● If the participant is due to complete assessments and whether or not those assessments will be 
administered at the time of discontinuation 
 
For any participants that discontinues due to a health issue, hospitalization or otherwise and wishes to 
continue treatment, we will offer to re-baseline them and re-enroll them in a subsequent wave of 
treatment to ensure that the challenge that existed in their life does not keep them from being able to 
participate.  
3. 
7.3     LOST TO FOLLOW-UP 
 
The following actions must be taken if a participant fails to answer the phone with attempts to administer 
treatment and collect data: 
 
● We will attempt to contact the participant, reschedule the missed survey or call with the trained 
helper within the next 72 hours and ascertain if the participant wishes to and/or should continue in 
the study. 
● Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls or reach out to the 
designated senior center case manager). These contact attempts will be documented in the 
participant’s study file.  
● Should the participant continue to be unreachable, he or she will be considered to have withdrawn 
from the study with a primary reason of lost to follow-up. 
 
As far as any missing data that may result, we are utilizing the Intent to Treat (ITT) approach therefore all 
data from any participants lost to follow-up will be included, and data not collected left blank in the 
longitudinal multilevel modeling analysis.  
10. 
8       STUDY ASSESSMENTS AND PROCEDURES 

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1. 
8.1     ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
 
Research Measures for BE WITH 
Socialization 
 
1. University of California, Los Angeles Loneliness Scale (UCLA) measures loneliness 
 
https://fetzer.org/sites/default/files/images/stories/pdf/selfmeasures/Self_Measures_for_Loneliness_and_I
nterpersonal_Problems_UCLA_LONELINESS.pdf 
 
2. Social Provisions Scale (SPS-5) measures social needs (table 2). 
 
https://www.canada.ca/en/public-health/services/reports-publications/health-promotion-chronic-disease-
prevention-canada-research-policy-practice/vol-39-no-12-2019/original-quantitative-research-social-
provisions-scale.html 
 
Health and Wellbeing 
 
3. Generalized Anxiety Disorder (GAD-7) measures anxiety. 
 
https://adaa.org/sites/default/files/GAD-7_Anxiety-updated_0.pdf 
 
4. Patient Health Questionnaire (PHQ-9) measures depression. 
 
https://med.stanford.edu/fastlab/research/imapp/msrs/_jcr_content/main/accordion/accordion_content3/do
wnload_256324296/file.res/PHQ9%20id%20date%2008.03.pdf 
 
5. Short Form Health Survey (SF-12) measures quality of life. 
 
https://www.hoagorthopedicinstitute.com/documents/content/SF12form.pdf 
 
6. Interpersonal Needs Questionnaire (INQ-15) measures suicide desire. The team will be using the 
thwarted belongingness scale only due to results from previous study. 
https://psy.fsu.edu/~joinerlab/measures/INQ-15.pdf 
7. Session rating scale measures the quality of the therapeutic alliance between a counselor and a 
client. This scale was adapted from a clinical context to assess the alliance between the older adult 
client and the volunteer/provider. 
https://www.uvm.edu/~cpincus/Session%20Rating%20Scale.pdf 
 
Measure 
Acronym What it 
measures 
When to 
measure 
Reliability/ 
Validity 
Number 
of items 
Sponsor 
(ACL) 
Category 

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University of 
California, 
Los Angeles 
Loneliness 
Scale 
UCLA 
Loneliness 
All time 
points 
Cronbach’s 
alpha: 0.72 
Discriminant 
validity and 
convergent 
validity 
demonstrated  
3 items 
Category 2: 
Socialization 
Generalized 
Anxiety 
Disorder 
GAD-7 
Anxiety 
All time 
points 
Cronbach’s 
alpha: 0.92 
 
Good criterion, 
construct, 
factorial and 
procedural 
validity 
demonstrated 
7 items 
Category 3: 
Health and 
Well-being 
Patient Health 
Questionnaire 
PHQ-9 
Depression 
All time 
points 
Cronbach’s 
alpha: 0.89 
Good 
concurrent 
validity when 
compared with 
SRQ-20 (71%, 
p < 0.001) and 
construct 
validity 
demonstrated 
10 items 
Category 3: 
Health and 
Well-being 
Social 
Provisions 
Scale 
SPS-5 
Social Needs 
Being Met 
All time 
points 
Cronbach’s 
alpha: 0.88 
Criterion-
related and 
structural 
validity 
demonstrated 
  
5 items 
Category 2: 
Socialization 
Short Form 
Health Survey 
SF-12 
Quality of 
Life 
All time 
points 
Reliability: test-
retest 
correlation of 
0.76 for 12-item 
Mental 
Component 
Summary 
(MCS) 
 
12 items 
Category 3: 
Health and 
Well-being 

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Relative 
validity 
estimates for 
12-item MCS 
ranged from 
0.60 to 1.07 
(median = 0.97) 
in relation to 
36-item short-
form scale 
Interpersonal 
Needs 
Questionnaire 
INQ-15 
Suicide 
Desire- 
thwarted 
belongingness 
scale only 
All time 
points 
Reliability: 
Thwarted 
Belongingness - 
Cronbach’s 
alpha: ~ 0.85 
 
Good construct 
validity 
(thwarted 
belongingness 
correlated 
significantly 
with loneliness 
and low social 
support) and 
criterion-related 
validity 
(thwarted 
belongingness 
uniquely 
predicts current 
suicidal 
ideation: odds 
ratio = 1.59, p < 
.01) 
15 items 
(8 TB) 
Category 3: 
Health and 
Well-being 
**Please review the table below for a summary of the main mental health measures utilized in this 
PN-RCT. 
 
Participant screening includes administration of the UCLA, INQ, and SPS, scoring them, and assigning a 
risk tier. Participants that are middle or high risk will be enrolled in the trial, whereas those that are low 
risk do not meet eligibility and will be called back to clarify/answer any questions they may have. 
Measures will be scored the same day, risk tiers and randomization assigned the same day, whereas the 
call backs to participants may take up to 72 hours.  
 
Trained graduate student data collectors will be administering all assessments via the phone verbally to 
older adults. Each received training and administered the measure set, was provided with feedback, and 
made adjustments to ensure that the measures were administered with fidelity across the trial. Further, 

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there were notations in Qualtrics to indicate reverse coded items, etc., in which wording may be 
particularly confusing to older adults to remind data collectors to slow down, repeat, and/or rephrase to 
ensure that the older adult understood each and every item.  
 
2. 
8.2     SAFETY ASSESSMENTS 
 
If a participant meets risk criteria for suicide desire at baseline, they are provided in real time, from data 
collectors, local and national resources (i.e. 1-800-SUICIDE, 988, local crisis center, G-CAL, etc.). If 
they remain at heightened risk over time, the PI and research team will communicate that to the senior 
center case manager assigned to their case.  
 
3. 
8.3     ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
1. 
8.3.1  DEFINITION OF ADVERSE EVENTS 
This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any untoward medical 
occurrence associated with the use of an intervention in humans, whether or not considered intervention-
related. 
 
2. 
8.3.2  DEFINITION OF SERIOUS ADVERSE EVENTS 
Refer to your institutional review board for the latest guidance and definition of Serious Adverse Events 
(SAE). In some cases, it may be appropriate to create a list of expected events that do not need to be 
reported to the IRB.  
 
3. 
8.3.3  CLASSIFICATION OF AN ADVERSE EVENT 
1. 
8.3.3.1    SEVERITY OF EVENT 
 
All adverse events will be assessed by the Principal Investigator, Dr. Laura Shannonhouse, and if 
necessary one of the two Co-PIs, Drs. Matthew Fullen or Dr. Erika LeBlanc. For any adverse events 
(AEs) not included in the protocol, the following guidelines will be used to describe severity.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities (i.e. daily life stressor, etc.).  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning (i.e. illness, new 
diagnosis, etc). 
• 
Severe – Events interrupt a participant’s usual daily activity, potentially life-threatening or 
incapacitating (i.e. medical hospitalization, death, etc.) 
 
2. 
8.3.3.2 
 
 
 
 
RELATIONSHIP 
TO 
STUDY 
INTERVENTION/EXPERIMENTAL MANIPULATION 

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All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed by an appropriately-trained clinician/researcher. The degree of certainty about causality will be 
graded using the categories below.  
 
• 
Related – The adverse event is known to occur with the study procedures, there is a reasonable 
possibility that the study procedures caused the adverse event, or there is a temporal relationship 
between the study procedures and the event. Reasonable possibility means that there is evidence 
to suggest a causal relationship between the study procedures and the adverse event. 
• 
Not Related – There is not a reasonable possibility that the study procedures caused the event, 
there is no temporal relationship between the study procedures and event onset, or an alternate 
etiology has been established. 
3. 
8.3.3.3     EXPECTEDNESS  
 
A clinician/researcher with appropriate expertise in the treatment will be responsible for determining 
whether an adverse event (AE) is expected or unexpected. An AE will be considered unexpected if the 
nature, severity, or frequency of the event is not consistent with the risk information previously described 
for the study procedures. 
 
4. 
8.3.4  TIME 
PERIOD 
AND 
FREQUENCY 
FOR 
EVENT 
ASSESSMENT AND FOLLOW-UP 
 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during the treatment, and/or data collection. 
 
All AEs, not otherwise precluded per the protocol, will be captured on our lab tracking file. Information 
to be collected includes event description, time of onset, severity, relationship to study procedures, and 
whether or not the AE will impact the participant’s ability to participate. All AEs occurring while on 
study will be documented appropriately regardless of relationship.  
 
All AEs will attempt to be followed up with resolution, to the degree possible.  However, in some cases, 
resolution may not be possible (i.e. hospitalization, death).  
 
Data collectors will record any AEs that present during data collection, and treatment providers will 
record any AEs that present during treatment.  
 
5. 
8.3.5 ADVERSE EVENT REPORTING  
There are no responsibilities of investigators for reporting of AEs outside of the study team and the 
clinical database with the exception of sustained suicide risk, which as previously noted will be reported 
to the case managers assigned to those particular older adult participants. This is noted in our MOUs with 
the 22 participating counties.  
 

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6. 
8.3.6  SERIOUS ADVERSE EVENT REPORTING  
 
In consultation with the PI, a trained member of the study team will be responsible for conducting an 
evaluation of a serious adverse event and shall report the results with the sponsor, and if relevant the 
participating AAAs (Area Agencies on Aging).  
 
7. 
8.3.7  REPORTING EVENTS TO PARTICIPANTS  
 
N/A 
 
8. 
8.3.8  EVENTS OF SPECIAL INTEREST  
N/A 
 
9. 
8.3.9  REPORTING OF PREGNANCY  
 
N/A 
 
4. 
8.4 
UNANTICIPATED PROBLEMS 
1. 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP). OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
2. 
8.4.2  UNANTICIPATED PROBLEMS REPORTING  
 
The Principal Investigator will report any unanticipated problems (UPs) to the Institutional Review Board 
(IRB) and to the sponsor.  
 
Any UP report will include the following information: 
 

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• 
Grant #/IRB # 
• 
A detailed description of the event, incident, experience, or outcome  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP 
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
 
• 
UPs that are serious adverse events (SAEs) will be reported to the PI’s Office of Research and 
Compliance (IRB) within 7 days of when they arise 
• 
If there are any deviations from the protocol, a protocol deviation form will be submitted to the 
Office of Research and Compliance within 7 days of the deviation 
• 
Upon reconciliation of the deviation, the PI will provide written documentation through federal 
monitoring reports of any AEs and/or protocol deviations 
 
3. 
8.4.3 REPORTING 
UNANTICIPATED 
PROBLEMS 
TO 
PARTICIPANTS  
N/A 
 
11. 
9         STATISTICAL CONSIDERATIONS  
 
1. 
9.1 
STATISTICAL HYPOTHESES 
 
Primary Endpoint(s):  
We hypothesize that older adults in both calling conditions will have reduced: social isolation, loneliness, 
depression, anxiety, mental health distress, and suicide desire; and they will have increased: social 
connection, social support, and well-being over time and in comparison to those in the control condition.  
 
Secondary Endpoint(s): 
We hypothesize that volunteers in both treatment conditions will demonstrate positive global counseling 
behaviors: demographics, The Empathy scale; however, those trained in BE WITH will more often 
employ suicide intervention practices when needed: SIRI-2. 
 
2. 
9.2 
SAMPLE SIZE DETERMINATION 
 
To determine appropriate sample sizes, we used formulas developed for PN-RCTs with continuous 
outcomes76 and binary outcomes77 as well as results from a closely related study52 that tested the effect of 
the ASIST intervention with similar outcome measures. To detect an effect size of .40 with a continuous 
outcome, utilizing a Type I error rate of .05, power of .80, ICC of .20, and R2 of .50 (for baseline 
covariate), we need 270 older adults with 30 volunteers each calling 6 older adults. For a binary outcome 
under the same assumptions,78,79 we would require 414-522 older adults with 46-58 volunteers for most 
estimates of the probability of an outcome in the treatment and control groups. Recruiting 540 older 

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adults (180 in each condition) and 60 volunteers (30 for each treatment condition) provides an adequate 
sample to evaluate major effects of interest in all proposed analyses.80 
 
3. 
9.3 
POPULATIONS FOR ANALYSES 
The population for analysis includes all randomized participants who met inclusion criteria.  We are using 
the Intention-to-Treat (ITT) Approach, meaning that even those participants that had an AE or dropped 
out of the treatment will still be included.  
 
4. 
9.4 
STATISTICAL ANALYSES 
1. 
9.4.1 GENERAL APPROACH 
For descriptive statistics, categorical and continuous data will be presented percentages, means with 
standard deviations, and ranges. For qualitative research, procedural and interpretive rigor will be 
monitored and maintained with the use of particular CQR methodology such as Consensual Qualitative 
Research43,44 paired with odds ratio analysis to ensure that there are no demographic or treatment 
confounders. For inferential tests, we will use p-value at .01 and confidence intervals for statistical 
significance, along with effect sizes, etc. Covariates and confounders are pre-specified in the sections 
below. Checks of assumptions (e.g., normality) underlying statistical procedures will be performed and 
any corrective procedures needed and recommended by our biostatistician will be applied. 
 
2. 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 
This validation study is a partially nested randomized controlled trial design (PN-RCT74-77) with a two-
level structure of clients (level-1) nested within callers (level-2) for the two treatment conditions which 
receive calls. Given that outcomes for older adults receiving calls from the same volunteer may be more 
similar than for those who receive calls from a different volunteer, the use of multilevel modeling can 
account for these data dependencies. Analyses will investigate the effect of treatment conditions (BE, BE 
WITH, and control) on post-intervention outcomes while controlling for baseline responses (prior to 
intervention). Furthermore, analyses will explore differences between treatment conditions in longitudinal 
trends of client state as well as how volunteers utilize specific intervention skills over time. For this 
longitudinal data, a lower level of nesting will be included in the analysis: weekly call and state data 
(level 1) nested within older adults (level 2) nested within volunteers (level 3). However, the PN-RCT 
design would only have levels 1 and 2 for the control group. 
 
3. 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
Analysis of the secondary endpoint(s) are not dependent on findings of the primary endpoint. The SIRI-2, 
an objective measure of suicide intervention skills, is calculated by comparing the trained helpers 
(paraprofessionals’) ratings of how helpful or harmful a suicide intervention response was to a suicidal 
scenario to expert, criterion ratings.  The top score one can make on the SIRI-2 is a 13, with 60 being 
fairly common in crisis center volunteers and most lay providers scoring in the 90s.  Higher scores mean 
lower skills on SIRI-2, and the PI on this team developed new scoring and subscales45 which also gets at 

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the degree to which a trained helper may underestimate the harmfulness of a response or overestimate the 
helpfulness of responses, enabling a second more nuanced scoring process. The Empathy scale is a Likert 
type self-report measure that is continuous. Repeated Measures ANOVA will be used to assess the degree 
to which trained helpers’ suicide intervention skills and empathy are impacted as a result of the training 
(pre/post training measures) as well as at the end of the treatment (third and final measurement occasion). 
Demographics, prior training, prior experience and role will be evaluated as potential confounders. 
Results of RMANOVA will be presented with standard errors or effect size. Multiple imputation will be 
used to address any missing data.  
 
4. 
9.4.4 SAFETY ANALYSES 
N/A 
 
5. 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
For primary endpoints, tests of baseline equivalence will be run to ensure fair comparison across 
treatment groups, ensure outcomes can be attributable to the treatment, for enhancing validity, and for 
informing decisions about pooling data. 
 
6. 
9.4.6 PLANNED INTERIM ANALYSES  
 
Since the clinical trial is structured to occur in cohorts, the longitudinal multilevel modeling (growth 
modeling) analysis will be run after each cohort is completed.  Despite early cohorts being underpowered, 
we find significant value in understanding if the data are trending in the expected directions, and/or if 
there are any issues that need to be addressed.  The methodologist running the analysis will remain 
unblinded throughout the analysis process.  There are no temporary suspension or safety findings that 
would prompt temporary suspension of the treatment.  The frequency of monitoring the end points is 
daily as older adult participants are on a rolling recruitment and finishing their treatment at different 
points in time. There is no effect of the interim analysis on the final analysis as it is the same analysis. 
Type I error results when running many different types of tests, however we are running the main analysis 
with an underpowered sample so that we are learning and understanding as we go.  The final analysis will 
be the same code just with all the participants across all 4 cohorts.  
7. 
9.4.7 SUB-GROUP ANALYSES 
Sub-group analyses on the primary endpoints will be assessed in two ways: (a) multi-level modeling by 
treatment severity group (same primary analysis, conducted independently for low, medium, and high risk 
patients), and (b) cluster analysis to explore any potential differential treatment effects across predefined 
patient subgroups (e.g., age, sex, race, etc.). Interaction terms between any subgroup variables (i.e. age, 
sex, baseline severity) and treatment condition will be included to assess whether the trajectory of 
outcomes over time varied by subgroup. This approach will enable the examination of both between- and 
within-patient variability while accounting for repeated measures and clustering. 
Since the secondary endpoints are serving as a fidelity check (i.e. trained helpers increased skills, retained 
skills, etc.) and were are only planning for approximately 60 trained helpers, which would be under 
powered, any differences in sub-groups, we imagine will be challenging to detect.  Despite this, 

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RMANOVA assesses mean differences across multiple time points, accounting for the within-subject 
correlation inherent in repeated measurements. Sub-group analysis will include testing interaction effects 
between time and categorical subgroup variables (e.g., age, sex, race) to determine if outcome trajectories 
differ across these groups. 
 
8. 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
While individual participant data will be tracked by measure and time point, results will be presented in 
group form. 
 
9. 
9.4.9 EXPLORATORY ANALYSES 
In addition to the main clinical trial analysis, and sub-group analyses this team will run a series of 
additional analyses to learn the most from this trial.  These include a series of moderation analyses, both 
cross-sectionally and longitudinally, as there is literature to support rurality as a moderator, as well as the 
therapeutic alliance. We also plan to run an analysis on the long-term effects of the treatment. We will 
analyze qualitative data using Consensual Qualitative Research methodology, as well as Content Analysis 
to look both across participants, and deeply at each treatment dosage of a random sample of participants. 
Finally, we will be evaluating the treatment dosages by applying a quantitative coding protocol and 
running additional multilevel modeling, and triangulation between the measurement data described above 
and these coded audio files of treatment dosages.  
 
12. 
10       SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
1. 
10.1 
REGULATORY, 
ETHICAL, 
AND 
STUDY 
OVERSIGHT 
CONSIDERATIONS 
 
1. 
10.1.1 INFORMED CONSENT PROCESS 
 
1. 
10.1.1.1    CONSENT/ASSENT AND OTHER INFORMATIONAL 
DOCUMENTS PROVIDED TO PARTICIPANTS 
 
Informed Consent for Older Adult Clients 
Title: A partially nested randomized controlled trial of the BE WITH innovation 
Principal Investigator: Dr. Laura Shannonhouse 
Sponsor: Administration for Community Living 
 
I. Introduction and Key Information: The purpose of the study is to investigate the BE WITH 
innovation. You are invited to participate because you are an older adult receiving now, or who recently 
received, home and community-based services from a Meals on Wheels organization or County Senior 

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Center with whom we collaborate. A total of up to 1100 older adults will be recruited for this project. If 
you choose to participate, you will take a survey that will determine your eligibility, and you will be 
compensated for your time to take this survey. If you meet eligibility for the program, your role in the 
study will require up to 40 minutes each week (for 8 weeks). Depending on your randomly assigned 
group, this time may be spent talking on the phone, and/or answering a short survey. The risks of being in 
this study include potentially experiencing some minimal worry or anxiety when you are talking about 
any stressors you may be experiencing, however research has shown that talking about it helps in the long 
run. This study is designed to benefit you, as the BE WITH program is designed to give more 
interpersonal connections to older persons. Overall, we hope to learn from you about how nutrition 
services can provide more support to older adult clients. 
 
II. Purpose: The purpose of the study is to investigate the BE WITH training for nutrition service 
volunteers and understand how it impacts the wellbeing of nutrition service clients. You are invited to 
take part in this research study because you are, or have recently been, a nutrition service client. A total of 
60 volunteers will be invited to take part in this study along with up to 1100 older adults. 
 
III. Procedures: If you decide to take part, you will talk to a student by phone who will ask you some 
questions in a survey. You will receive $20 for taking this survey. Based on that survey, if you meet 
criteria for the program, we will contact you, and you will be assigned to either a study group or a control 
group. If you are assigned to the study group, you will be called by a volunteer once per week for 8 
weeks, and using an audio feature on teleconferencing software, both you and the volunteer will be 
recorded. However, all identifying information will be removed from the recordings. During this project, 
you may receive a call from a number you do not recognize. This will be the software we are using to 
connect you with volunteers, and to keep both of your identities safe. Once the call is recorded, no one 
will be able to connect your name or number to the recording. All involvement with this project will be 
done remotely, therefore you can participate from your home. All participants who enroll in the program 
are asked to spend 15-20 minutes completing a survey every other week over the phone. 
 
IV. Future Research: Researchers will remove information that may identify you and may use your data 
for future research. If we do this, we will not ask for any additional consent from you. 
 
IV. Risks: There is the possibility that participation in this project may cause you to feel some worry or 
concern - for example, the volunteer may ask you about how you’re coping with a current life stressor 
you are experiencing as they talk with you, and this may bring up feelings of anxiety. However, research 
has shown that by talking about things that are on our mind we feel better. If you experience any concern, 
we are available to answer any questions you may have and to provide support. No injury is expected 
from this study, but if you believe you have been harmed, contact the research team as soon as possible. 
The research team and their affiliates have not set aside funds to compensate for any injury. Overall, we 
expect the risk of participation will be low/minimum. 
 
IV. Benefits: Participation in this study may benefit you personally. Research has shown that connecting 
with others during crisis, disaster, and pandemic is helpful. Overall, we hope to gain information about 
the BE WITH innovation, and ideally submit BE WITH to be accepted on the National Council on 
Aging’s (NCOA) evidence-based registry to enable warm calling programs to occur across the US. 
Currently, there is no program to make warm calls, or visits remotely on the NCOA registry, so you are 
helping us make that happen. 
 
VII. Alternatives: The alternative to taking part in this study is to not take part in the study. 
 
VIII. Compensation: If you choose to participate, and do not meet eligibility criteria, you will be 
provided $20 dollars for taking the baseline survey and your involvement will be complete at that time. If 

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you do meet criteria to be enrolled in the BE WITH program, based on your assigned group, you will be 
required to take part in weekly phone calls and/or complete a survey every other week. If you are eligible 
and choose to participate, you will be mailed $20 cash at the start of the 8 weeks, and $80 in cash after 
you complete the eight-week program. This means that you are entitled to $100 total if you complete the 
eight-week program. 
 
IX. Voluntary Participation and Withdrawal: Your participation is voluntary. You do not have to be 
involved in this project. If you decide to be in the study and then change your mind, you have the right to 
drop out at any time. You may stop participating at any time. If you stop participating, this will not cause 
you to lose any compensation you have already received, but you will not receive any future payments. 
 
X. Confidentiality: We will keep your records private to the extent allowed by law. The following people 
will have access to any information that you provide: 
● Dr. Shannonhouse and Kirsty Houston 
● Institutional Review Board 
● The Administration for Community Living (part of the Federal Department of Health and Human 
Services) 
 
We will use two different codes to ensure we de-identify you from your data.  The first is a numeric code 
that is assigned to you, and the second is a code generated from a combination of your initials and county 
both de-identify you on project records to protect your confidentiality. The information gathered from the 
calls will be stored on a password-protected and firewall-protected computer. The key that holds your 
code will be stored separately from the data to protect your privacy. The audio recordings and any 
transcripts will be destroyed within 5 years of completing the study, along with the code key information. 
Since any information that is sent over the internet may not be secure, we are only using data encrypted 
protocols and are not logging IP addresses. Also, only the case managers at the participating agency will 
know that you have elected to participate. That person will not have any access to any of your data and 
will not even know which group you have been assigned to. 
 
XI. Contact Persons: Contact Dr. Laura Shannonhouse at 352.359.0950 or lshannonhouse@coe.ufl.edu 
● If you have questions about the study or your part in it 
● If you have questions, concerns, or complaints about the study 
The IRB reviews all research that involves human participants. You can contact the IRB if you would like 
to speak to someone who is not involved directly with the study. You can contact the IRB for questions, 
problems, information, input, or questions about your rights as a research participant.  
 
XII. Consent: We will give you a copy of this consent form to keep. 
 
2. 
10.1.1.2   CONSENT PROCEDURES AND DOCUMENTATION 
 
Informed consent will be administered over the phone to potential older adult participants. If they 
consent, older adult participants will be provided the baseline measure set, and informed that they will be 
subsequently contacted after they are assigned a treatment condition. After scoring their measures, and 
weighted stratified random assignment, participants will be mailed a participation plan. A member of the 
research team will also go over the details regarding their participation with them over the phone during 
the call back.  
 
2. 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 

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This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to study participants, investigator, funding agency, and regulatory 
authorities. If the study is prematurely terminated or suspended, the Principal Investigator (PI) will 
promptly inform study participants, the Institutional Review Board (IRB), and sponsor/funding agency 
and will provide the reason(s) for the termination or suspension. Study participants will be contacted, as 
applicable, and be informed of changes to study schedule. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
● Determination of unexpected, significant, or unacceptable risk to participants 
● Insufficient compliance of study staff to the protocol  
● Determination that the primary endpoint has been met 
● Determination of futility 
● The funding that has been secured is cut early and abruptly 
 
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency, sponsor, IRB, or other relevant regulatory or oversight bodies. 
 
3. 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
All records will be kept private to the extent allowed by law. The following people will have access to 
identifiable information: 
● Dr. Shannonhouse and Kirsty Houston 
● Institutional Review Board 
● The Administration for Community Living (part of the Federal Department of Health and Human 
Services) 
 
We will use two different codes to ensure we de-identify you from your data.  The first is a numeric code 
that is assigned to you, and the second is a code generated from a combination of your initials and county 
both de-identify you on project records to protect your confidentiality. The information gathered from the 
calls will be stored on a password-protected and firewall-protected computer. The key that holds your 
code will be stored separately from the data to protect your privacy. The audio recordings and any 
transcripts will be destroyed within 5 years of completing the study, along with the code key information. 
Since any information that is sent over the internet may not be secure, we are only using data encrypted 
protocols and are not logging IP addresses. Also, only the case managers at the participating agency will 
know that you have elected to participate. That person will not have any access to any of your data and 
will not even know which group you have been assigned to. 
 
4. 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
 
After the study is completed, the de-identified, archived data will be stored, and made available for use by 
other researchers including those outside of the study if deemed appropriate. Data will not be transmitted 
to any other entity unless the PI moves universities.  
 

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5. 
10.1.5 KEY 
ROLES 
AND 
STUDY 
GOVERNANCE 
 
Principal Investigator 
Medical Monitor or Independent Safety Monitor 
Dr. Shannonhouse, Ph.D., Associate Professor 
Dr. Barrio Minton, Ph.D., Professor 
University of Florida 
University of Tennessee  
1602 Norman Hall, Gainesville FL 32611 
444 Claxton Education Building, 1122 Volunteer Blvd 
352.359.0950 
865-974-8382 
lshannonhouse@coe.ufl.edu 
cbarrio@utk.edu 
 
6. 
10.1.6 SAFETY OVERSIGHT 
 
Safety oversight will be accomplished through a quality assessment by an outside external evaluator, Dr. 
Casey Barrio Minton, a full professor with program evaluation expertise, millions of dollars in external 
funding, and leadership roles in this content area. She is independent from the study, free of conflicts of 
interest, and will conduct evaluations prior to the start of the trial, monitoring checks during it, and then a 
formalized evaluation after the trial is complete with all levels of participation (i.e. research team 
members, leadership, trained helpers providing the treatment, participants, etc.).  
 
7. 
10.1.7 CLINICAL MONITORING 
 
Clinical coordinators will lead weekly accountability groups with trained helpers. These individuals 
will monitor the administration of the treatment, timing, call dose duration, and provided regular and 
routine feedback to the trained helpers providing the treatment.   
 
8. 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
The PI and methodologist (Drs. Kirpich and Shannonhouse) will perform internal quality management of 
survey data (baseline and 5 measurement occasions) as well as the audio file and transcript data. Quality 
control (QC) procedures will be implemented as follows: 
 
Informed consent --- Study staff will review both the documentation of the consenting process as well as 
a percentage of the completed consent documents.  This review will evaluate compliance with the 
research protocol (and data collection training), accuracy, and completeness of data.  Feedback will be 
provided to data collectors to ensure proper consenting procedures are followed.  
 
Source documents and the electronic data --- Data will be initially captured on source documents (see 
Section 10.1.9, Data Handling and Record Keeping).  To ensure accuracy, study staff will compare a 
representative sample of source data against the database, targeting key data points in that review. 
 
Intervention Fidelity — Consistent delivery of the study interventions will be monitored throughout the 
intervention phase of the study. Procedures for ensuring fidelity of intervention delivery are described in 
Section 6.2.1, Interventionist Training and Tracking.  

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Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern. 
 
Should independent monitoring become necessary, the PI will provide direct access to de-identified 
source data/documents, and reports for the purpose of monitoring and auditing by the sponsor/funding 
agency, and/or inspection by local and regulatory authorities. 
 
9. 
10.1.9 DATA HANDLING AND RECORD KEEPING  
 
1. 
10.1.9.1    DATA COLLECTION AND MANAGEMENT 
RESPONSIBILITIES  
 
Data collection will be the responsibility of the clinical trial data collection staff under the supervision of 
Principal Investigator, Methodologist, and Co-Investigators. While all will be responsible for accuracy, 
completeness, and timeliness of the data reported, the PI and Methodologist are taking lead on tracking 
and cleaning of all data in real time, and will give feedback as needed to data collectors to ensure 
accuracy, completeness, and timeliness. All source documents will be completed in a neat, legible manner 
to ensure accurate interpretation of data.   
 
Data collectors will regularly and routinely log meta-data on the data collection in a share file that is de-
identified.  This enables them to communicate with one another which participants have had data 
collection for which measurement occasions.   
 
Clinical meta-data (i.e. treatment dose date, time, duration, etc.) as well as outcome data (i.e. audio files 
of treatment dosages and transcripts) will be automatically collected via the Friendlybuzz system. 
Friendlybuzz and Qualtrics (two data storage systems) both include password protection and internal 
quality checks. 
 
2. 
10.1.9.2    STUDY RECORDS RETENTION  
 
Study documents will be retained for a minimum of 5 years after the last approval of a marketing 
application or published journal article. These documents should be retained for a longer period, however, 
if required by local regulations. No records will be destroyed without the written consent of the 
sponsor/funding agency, if applicable. It is the responsibility of the sponsor/funding agency to inform the 
investigator when these documents no longer need to be retained. 
10. 
10.1.10 
  PROTOCOL DEVIATIONS   
 
It will be the responsibility of any grant key personnel (i.e. investigators, methodologist, data collectors, 
treatment providers, etc.) to use continuous vigilance to identify and report deviations within 24 hours of 

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identification of the protocol deviation to the Principal Investigator/Project Director. Any and all 
deviations will be reported to the Office of Research and Compliance at the PI’s primary institution, as 
well as the federal sponsor. Finally, if any such deviations occur, they will be discussed as a team to 
ensure learning and prevention of any future deviations.  
 
11. 
10.1.11 
  PUBLICATION AND DATA SHARING POLICY  
 
To determine authorship on manuscripts that emerge from this grant, this team will utilize the APA 
Authorship Determination Scorecard. The structured tool is designed to identify activities, allocate credit, 
and determine an order of authorship in research projects. Based on the significance and workload of each 
activity, points are allocated to the items. Contributors to each article are then evaluated based on their 
involvement with each scholarly activity, and individually assigned a proportional number of points 
relevant to their contributions. The sum of points for each contributor then determines their overall 
contribution score. Authorship is structured in an order of highest scoring contributions to the lowest.  
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: National Institutes of Health (NIH) Public Access Policy, which ensures that the public has 
access to the published results of federally funded research. It requires scientists to submit final peer-
reviewed journal manuscripts that arise from federal funds to the digital archive PubMed Central upon 
acceptance for publication. 
 
Dissemination will be informed by the Yale Center for Clinical Investigation best practices, including (a) 
leveraging existing resources, relationships, and networks fully, (b) delivering scholarly data-driven 
manuscripts, (c) delivering data-driven formal presentations (i.e., conference talks) to inform  practice, 
service delivery, program development, and policy making, (d) translating findings to  communicate 
properly with community members through non-academic outlets (i.e., op-eds; press  releases), (e) 
providing research summaries of relevant key findings for Area Agencies on Aging, (f)  providing an 
expanded research summary (policy research) document to key ASN stakeholders, and (g)  using the 
project work plan to guide efforts.   
 
12. 
10.1.12 
  CONFLICT OF INTEREST POLICY 
 
Any conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any 
aspect of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict of 
interest will be required to disclose those conflicts a priori, and have such conflicts managed in a way that 
is appropriate to their participation in the design and conduct of this trial.  
 
2. 
10.2 
ADDITIONAL CONSIDERATIONS 
There are no additional considerations not currently covered in this protocol template, such as particular 
institutional or IRB-related requirements.  
 

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3. 
10.3 
ABBREVIATIONS AND SPECIAL TERMS 
 
ACL 
Administration for Community Living 
ARC AAA 
Atlanta Regional Commission Area Agency on Aging 
ASIST 
LivingWorks Applied Suicide Intervention Skills Training 
ASN 
Aging Services Network 
BE 
Belonging & Empathy Trained Volunteers 
BE WITH 
Belonging & Empathy With Intentional Targeted Helping 
Co-PIs 
Co-Principal Investigators Dr. Fullen & LeBlanc 
CP 
Community Partners (GA DAS, NC DAAS, ARC AAA) 
DC 
Data Coders / Collectors 
EE 
External Evaluator Dr. Barrio Minton 
GA DAS 
Georgia Department of Aging Services 
IPTS 
Interpersonal Theory of Suicide 
IRB 
Institutional Review Board 
IS 
Implementation Support 
M 
Methodologist Dr. Kirpich 
MHS 
Mental Health Coordinators 
MSS 
Methodology Support Student 
NC DAAS 
North Carolina Division of Aging and Adult Services 
NCOA 
National Council on Aging 
NS 
Nutrition Services 
PD 
Project Director & Co-PI Dr. Shannonhouse 
PN-RCT 
Partially Nested Randomized Controlled Trial 
QR 
Qualitative Researcher Dr. Whisenhunt 
SAE 
Serious Adverse Event 
SILES 
Social Isolation, Loneliness, and Elevated Suicidality 
US 
United States 
VS 
NS Staff & Volunteers 
4. 
10.4 
PROTOCOL AMENDMENT HISTORY 
We will log any changes of IRB-approved versions of the protocol, and contextualize with a description 
of the change and rationale. 
13. 
11 
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