Older AdultsBE_WITHNCT07204444
The BE WITH Project: A Partially Nested Randomized Control Trial (PN-RCT)
A study testing standardized and manualized warm calls from providers trained in the BE training and standardized and manualized warm calls from providers trained in the BE training + ASIST training in people with Older Adults and Mental Health, run by University of Florida at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if the BE WITH (Belonging through Empathy With Intentional Targeted Helping) innovation delivered to older adults improves their mental health. It will also learn about the treatment components that led to improvements. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults, Mental Health, Depression
- What is being tested?
- standardized and manualized warm calls from providers trained in the BE training and standardized and manualized warm calls from providers trained in the BE training + ASIST training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 671 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 25 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of verbal informed consent,
- Classify as an Older Adult (55+),
- Stated willingness and ability to comply with all study procedures,
- Receive nutrition services through the Aging Services Network (i.e. either HDM (home delivered meals services) or CM (congregate meals)), and
- Be affiliated with one of the 25 senior centers we will contract with through a Memorandum of Understanding.
- Provision of written informed consent,
Show all 10Show fewer
- State willingness to comply with all study procedures,
- Be a staff or volunteer within the ASN (Aging Services Network), specifically within the 25 senior centers we are working with,
- Meet criteria identified by Wymann and colleagues (2009) for being a "natural helpers" (i.e. be warm, empathic, and having ongoing interaction with participants through one's job role), and
- Be recommended by the senior center leadership as meeting these qualifications.
Who cannot join
- Had a dementia diagnosis, or another form of cognitive impairment, and/or hearing impairment that would preclude phone conversation, and
- 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.
- 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), and
- Participation in another warm calling behavioral treatment or intervention study simultaneously occurring in this state.
Trial locations and contacts
1 site in 1 country.
United States1 site
Older Adults' Homes; Treatment Provided Over the Phone
Atlanta, Georgia, 30318
About this study
Official title: 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
The goal of this clinical trial is to learn if the BE WITH (Belonging through Empathy With Intentional Targeted Helping) innovation delivered to older adults improves their mental health. It will also learn about the treatment components that led to improvements. The main questions it aims to answer are:
- Over the course of the 8 week standardized and manualized warm calling treatment, are mental health outcomes improved for the BE and BE + ASIST (Applied Suicide Intervention Skills Training) treatment conditions relative to a control group?
- Are there differential outcomes for older adults who start the treatment at low, medium, or high risk? (as defined by a baseline aggregate of measures)?
- How is this improvement manifested for particular aspects of mental health (i.e. depression, social needs, suicide desire, and overall quality of life)?
Read more
Participants will:
- answer questions from a trained data collector to get their baseline,
- receive 8 weeks of warm calls for 2 months (if assigned to one of the 2 treatment conditions, if assigned to control they will have the option to receive treatment at a later time), and (c) be assessed every 2 weeks.
Read the detailed description
This study is a partially nested randomized controlled trial research design (PN-RCT) with a two-level structure of clients (level-1) nested within callers (level-2) for the two treatment conditions which receive calls. Given that outcomes for older adults receiving calls from the same treatment provider may be more similar than for those who receive calls from a different provider, the use of multilevel modeling can account for these data dependencies. The investigators will be investigating 1) how our BE WITH (Belonging through Empathy With Intentional Targeted Helping) innovation reduces social isolation, loneliness, and elevated suicidality among home delivered meal and former congregate meal 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. The investigators hypothesize that older adults in both treatment conditions will have reduced: social isolation, loneliness, depression, 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. The investigators will also investigate 2) how BE WITH improves the frequency of empathic and suicide intervention best practice behaviors by trained nutrition service providers. 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 skills and suicide intervention skills is challenging, 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.
- Conditions
- Older Adults, Mental Health, Depression, Loneliness, Social Isolation, Suicide Ideations
- Being tested
- standardized and manualized warm calls from providers trained in the BE training, standardized and manualized warm calls from providers trained in the BE training + ASIST training
- Keywords
- mental health clinical trial for older adults
- Medical subject headings
- Psychological Well-Being, Depression, Social Isolation, Social Adjustment, Help-Seeking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized and manualized warm calls from providers trained in the BE trainingBehavioural
Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
standardized and manualized warm calls from providers trained in the BE training + ASIST trainingBehavioural
Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
| Study group | Role | What they receive |
|---|---|---|
| BE Condition | Experimental | The BE condition which involves receiving treatment from providers trained to foster belongingness and empathy, grounded in the befriending literature (Wiles et al., 2019; Fakoya et al., 2021), and narrative reminiscence (Yousefi, 2015). Aging Network Providers trained in BE provide a "small dose of sincere connection" through 5 core components:
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 Receives: Behavioral: standardized and manualized warm calls from providers trained in the BE training |
| BE + ASIST Condition | Experimental | The BE + ASIST condition includes the BE training + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training; Lang et al., 2013). Analogous to CPR, paraprofessionals can learn "suicide first aid." Providers trained in ASIST are equipped to do a 6 step model (Pathway for Assisting Life (PAL)) to help stabilize a person at risk of suicide at the moment it needed the most. The PAL model matches six needs of the older adult-at-risk with six tasks of the treatment provider. These include (1) exploring invitations (i.e. voluntary stopping of eating and drinking, withholding medical treatment, etc.), 2. asking directly about suicide, 3. sincerely hearing the story about suicide, 4. working effectively with ambivalence about dying, and offering a 3rd option (to stay safe for now), 5. developing a mutually endorsed safety plan, and 6. confirming actions (asking the older adult to repeat the plan back to the provider) Receives: Behavioral: standardized and manualized warm calls from providers trained in the BE training + ASIST training |
| Control | No intervention | participants randomized to this condition will not receive call dosages during the clinical trial. However, they will have the option to receive call dosages after the 8 weeks have concluded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Provisions Scale (SPS-5)
The Social Provisions Scale (SPS-5) is a 5-item measure used to evaluate a participant's level of social support. It is a shortened version of the 10-item SPS and designed for use in research studies to reduce participant burden while maintaining strong psychometric properties. The SPS is based on a theory of social support developed by Irwin Weiss and uses one positive item to assess the social provisions of Attachment, Guidance, Social Integration, Reliable alliance, and Reassurance of worth. Each item is rated on a 4-point Likert scale, from "Strongly Disagree" to "Strongly Agree". Sample items include, "There is someone I could talk to about important decisions in my life", "I feel part of a group of people who share my attitudes and beliefs", and "There are people I can count on in an emergency." A total score is calculated by summing the responses to the 5 questions. The scores can range from 5 to 20, with higher scores indicating higher levels of perceived social support.
Measured: Baseline, Week 2, Week 4, Week 6 and Week 8
University of California, Los Angeles Loneliness Scale
The three-item UCLA Loneliness Scale (Hughes et al., 2004) is a widely used instrument for measuring subjective feelings of loneliness. The scale assesses three core dimensions of loneliness through corresponding items: relational connectedness ("How often do you feel that you lack companionship?"), social connectedness ("How often do you feel left out?"), and self-perceived isolation ("How often do you feel isolated from others?"). Participants respond using a 3-point scale ranging from "hardly ever" to "often." Total scores range from 3 to 9, with higher scores indicating greater loneliness. The scale demonstrates good psychometric properties in middle-aged and older adult populations.
Measured: Baseline, Week 2, Week 4, Week 6 and Week 8
Generalized Anxiety Disorder (GAD-7)
The GAD-7 is a 7-item questionnaire designed to assess the symptoms of Generalized Anxiety Disorder (GAD). Each item describes a common GAD symptom and is rated on a four-point scale (0-3) based on how often the individual has experienced that symptom over the past 2 weeks. The 7 questions assess feelings such as nervousness, inability to control worrying, trouble relaxing, restlessness, irritability, and feeling afraid. Sample items include, "how often have you felt nervous, anxious, or on edge", "how often have you worried too much about different things", "how often have you had trouble relaxing", and "fFelt afraid as if something awful might happen." Total scores range from 0 to 21, with higher scores indicating increased anxiety severity. Scores are categorized as: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), and 15-21 (severe anxiety).
Measured: Baseline, Week 2, Week 4, Week 6, Week 8
Patient Health Questionnaire - PHQ-9
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure to assess depressive symptoms in the past 2 weeks (Kroenke et al., 2001). The scale items correspond to the 9 diagnostic criteria for major depressive disorder. Respondents rate the frequency of each symptom on a 4-point scale ranging from "not at all" to "nearly every day." Sample items include "Little interest or pleasure in doing things" and "Poor appetite or overeating." Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. The PHQ-9 includes an additional functional impairment item that assesses how much the problems have affected the respondents' daily activities. The scale has shown strong psychometric properties across diverse populations. Among U.S. older adults, the PHQ-9 showed high sensitivity (88%) and specificity (80%) for identifying major depression, as well as the combination of major and minor depression (Phelan et al., 2010).
Measured: Baseline, Week 2, Week 4, Week 6 and Week 8
Short Form Health Survey (SF-12)
The Short Form Health Survey (SF-12) is a self-reported outcome measure to assess health-related quality of life. The raw answers from the 12 questions are processed to produce two main, standardized summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). We only used the MCS factor in this study as the treatment is targeting mental health. The MCS computed score has a range from 17 to 64 in the analysis and was based on the linear combination of six computed, generated, iterated weights. A low Mental Component Summary (MCS) score indicates poorer self-perceived mental health and lower health-related quality of life.
Measured: Baseline, Week 2, Week 4, Week 6 and Week 8
Interpersonal Needs Questionnaire (INQ-15)
The Interpersonal Needs Questionnaire (INQ; Van Orden et al., 2012) was used to evaluate thwarted belongingness and perceived burdensomeness through 15 items. We used an adapted version tailored specifically for older adults which includes 3-point Likert scale ranging from 1 (Not at all true for me) to 3 (Very true for me). The instrument includes 2 sets of characteristics: (1) the 9-item Thwarted Belongingness (e.g., "I feel disconnected from other people."); and (2) the 6-item Perceived Burdensomeness (e.g., "I think my death would be a relief to the people in my life."). Six questions from the Thwarted Belongingness subscale were reverse-coded when the overall score across questions was computed due to the nature of those questions. In particular, the total score on the INQ is calculated by summing the questions responses to all items and reversing the appropriate ones. As a result, greater scores on each subscale reflect higher levels of the respective construct being measured.
Measured: Baseline, Week 2, Week 4, Week 6 and Week 8
Secondary outcomes (1)
Session Rating Scale
The 4-item Session Rating Scale is a therapeutic practice measure that treatment recipients complete after receiving treatment. This allows trained helpers to make real-time adjustments to improve treatment effectiveness and prevent dropout. Participants marked their responses on a Likert-Scale, ranging from 0 to 10, representing: (a) the quality of the therapeutic relationship, (b) agreement on goals and topics, (c) the relevance and fit of the treatment provider's approach, and (d) the overall effectiveness of the treatment dosage. The scores for each domain were summed to generate a total possible score of 40. A total score below 36 or a score below 9 on any single item is a potential indicator of concern, which should prompt the therapist to discuss the issue openly with the client and make necessary adjustments to the session's direction or approach.
Measured: Baseline, Week 2, Week 4, Week 6 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Jun 2021
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 671 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia State University, Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Laura R Shannonhouse, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204444
- Sponsor's protocol ID
- 90INNU0021-03-00
- Other IDs
- 90INNU0021
- Acronym
- BE_WITH
- Status last verified
- Jun 2025
- First submitted
- 24 Sep 2025
- Last updated
- 12 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share participant data for several reasons: 1. Ensuring participant privacy: De-identification and secure data management are crucial to protect participant information, 2. Financial resources: Data sharing requires additional resources for data preparation, data sharing agreements, storage, and management which were not included in this grant, 3. Addressing potential biases: Sharing data must be done in a way that minimizes bias and allows for fair and transparent use.
Publications
Hill, C. E., Knox, S., Thompson, B.J., & Williams, E. N., (1997). A guide to conducting consensual qualitative research. The Counseling Psychologist, 25, 517-572. 44Hill, C. E., Knox, S., Thompson, B. J., Williams, E. N., Hess, S. A., & Ladany, N. (2005). Consensual qualitative research: An update. Journal of Counseling Psychology, 52, 196-205.
Efron, B. (1971). Forcing a sequential experiment to be balanced. Biometrika, 58(3), 403-417.
Lang, W. A., Ramsay, R. F., Tanney, B. L., Kinzel, T., Turley, B., & Tierney, R. J. (2013). ASIST trainer manual ( 11th ed.). Calgary, Alberta, Canada: LivingWorks Education.
Caplan, G. (1964). Principles of preventive psychiatry.
Yousefi Z, Sharifi K, Tagharrobi Z, Akbari H. The Effect of Narrative Reminiscence on Happiness of Elderly Women. Iran Red Crescent Med J. 2015 Nov 7;17(11):e19612. doi: 10.5812/ircmj.19612. eCollection 2015 Nov.
PubMed 26734470Fakoya OA, McCorry NK, Donnelly M. How do befriending interventions alleviate loneliness and social isolation among older people? A realist evaluation study. PLoS One. 2021 Sep 9;16(9):e0256900. doi: 10.1371/journal.pone.0256900. eCollection 2021.
PubMed 34499682Dale M, Fortin MJ. Spatial analysis: a guide for ecologists. Cambridge University Press; 2014.
Tseng C, Shao Y. Sample size growth with an increasing number of comparisons. J Probab Stat. 2012;2012:1-10.
Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.
PubMed 19565683Chow SC, Shao J, Wang H, Lokhnygina Y. Sample size calculations in clinical research. Chapman and Hall; 2017.
Lohr S, Schochet PZ, Sanders E. Partially Nested Randomized Controlled Trials in Education Research: A Guide to Design and Analysis. NCER 2014-2000. National Center for Education Research; 2014.
Friedman LM, Furberg CD, DeMets DL, Reboussin DM, Granger CB. Fundamentals of clinical trials. Springer; 2015.
Piantadosi S. Clinical trials: a methodologic perspective. John Wiley & Sons; 2017.
Mabli J, Gearan E, Cohen R, Niland K, Redel N, Panzarella E, Carlson B. Evaluation of the effect of the Older Americans Act Title III-C Nutrition Services Program on participants' food security, socialization, and diet quality. Washington, DC: US Department of Health and Human Services, Administration for Community Living; April 1, 2017-07. Retrieved from https://www.sustaintool.org/psat/.
Mabli J, Redel N, Cohen R, Panzarella E, Hu M, Carlson B. Process evaluation of Older Americans Act Title III-C nutrition services program. Washington, DC: US Department of Health and Human Services, Administration for Community Living; 2017-02
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07204444
- Acronym / sponsor ID
- BE_WITH / 90INNU0021-03-00
- Conditions
- Older Adults, Mental Health, Depression, Loneliness, Social Isolation, Suicide Ideations
- Keywords
- mental health clinical trial for older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 671 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Georgia State University, Department of Health and Human Services
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 2 Oct 2025 (actual)
- Results
- Posted 12 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if the BE WITH (Belonging through Empathy With Intentional Targeted Helping) innovation delivered to older adults improves their mental health. It will also learn about the treatment components that led to improvements. The main questions it aims to answer are:
- Over the course of the 8 week standardized and manualized warm calling treatment, are mental health outcomes improved for the BE and BE + ASIST (Applied Suicide Intervention Skills Training) treatment conditions relative to a control group?
- Are there differential outcomes for older adults who start the treatment at low, medium, or high risk? (as defined by a baseline aggregate of measures)?
- How is this improvement manifested for particular aspects of mental health (i.e. depression, social needs, suicide desire, and overall quality of life)?
Participants will:
- answer questions from a trained data collector to get their baseline,
- receive 8 weeks of warm calls for 2 months (if assigned to one of the 2 treatment conditions, if assigned to control they will have the option to receive treatment at a later time), and (c) be assessed every 2 weeks.
Detailed description
This study is a partially nested randomized controlled trial research design (PN-RCT) with a two-level structure of clients (level-1) nested within callers (level-2) for the two treatment conditions which receive calls. Given that outcomes for older adults receiving calls from the same treatment provider may be more similar than for those who receive calls from a different provider, the use of multilevel modeling can account for these data dependencies. The investigators will be investigating 1) how our BE WITH (Belonging through Empathy With Intentional Targeted Helping) innovation reduces social isolation, loneliness, and elevated suicidality among home delivered meal and former congregate meal 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. The investigators hypothesize that older adults in both treatment conditions will have reduced: social isolation, loneliness, depression, 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. The investigators will also investigate 2) how BE WITH improves the frequency of empathic and suicide intervention best practice behaviors by trained nutrition service providers. 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 skills and suicide intervention skills is challenging, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BE Condition | Experimental | Behavioral: standardized and manualized warm calls from providers trained in the BE trainingThe BE condition which involves receiving treatment from providers trained to foster belongingness and empathy, grounded in the befriending literature (Wiles et al., 2019; Fakoya et al., 2021), and narrative reminiscence (Yousefi, 2015). Aging Network Providers trained in BE provide a "small dose of sincere connection" through 5 core components: 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 |
| BE + ASIST Condition | Experimental | Behavioral: standardized and manualized warm calls from providers trained in the BE training + ASIST trainingThe BE + ASIST condition includes the BE training + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training; Lang et al., 2013). Analogous to CPR, paraprofessionals can learn "suicide first aid." Providers trained in ASIST are equipped to do a 6 step model (Pathway for Assisting Life (PAL)) to help stabilize a person at risk of suicide at the moment it needed the most. The PAL model matches six needs of the older adult-at-risk with six tasks of the treatment provider. These include (1) exploring invitations (i.e. voluntary stopping of eating and drinking, withholding medical treatment, etc.), 2. asking directly about suicide, 3. sincerely hearing the story about suicide, 4. working effectively with ambivalence about dying, and offering a 3rd option (to stay safe for now), 5. developing a mutually endorsed safety plan, and 6. confirming actions (asking the older adult to repeat the plan back to the provider) |
| Control | No intervention | –participants randomized to this condition will not receive call dosages during the clinical trial. However, they will have the option to receive call dosages after the 8 weeks have concluded. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provision of verbal informed consent,
- Classify as an Older Adult (55+),
- Stated willingness and ability to comply with all study procedures,
- Receive nutrition services through the Aging Services Network (i.e. either HDM (home delivered meals services) or CM (congregate meals)), and
- Be affiliated with one of the 25 senior centers we will contract with through a Memorandum of Understanding.
Key exclusion criteria (5 listed)
- Had a dementia diagnosis, or another form of cognitive impairment, and/or hearing impairment that would preclude phone conversation, and
- 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.
- 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), and
- Participation in another warm calling behavioral treatment or intervention study simultaneously occurring in this state.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardized and manualized warm calls from providers trained in the BE trainingWeekly call dosages averaging 20-30 minutes each, for 8 weeks duration | Behavioural | BE Condition |
| standardized and manualized warm calls from providers trained in the BE training + ASIST trainingWeekly call dosages averaging 20-30 minutes each, for 8 weeks duration | Behavioural | BE + ASIST Condition |
Primary outcome
Social Provisions Scale (SPS-5)
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
The Social Provisions Scale (SPS-5) is a 5-item measure used to evaluate a participant's level of social support. It is a shortened version of the 10-item SPS and designed for use in research studies to reduce participant burden while maintaining strong psychometric properties. The SPS is based on a theory of social support developed by Irwin Weiss and uses one positive item to assess the social provisions of Attachment, Guidance, Social Integration, Reliable alliance, and Reassurance of worth. Each item is rated on a 4-point Likert scale, from "Strongly Disagree" to "Strongly Agree". Sample items include, "There is someone I could talk to about important decisions in my life", "I feel part of a group of people who share my attitudes and beliefs", and "There are people I can count on in an emergency." A total score is calculated by summing the responses to the 5 questions. The scores can range from 5 to 20, with higher scores indicating higher levels of perceived social support.
University of California, Los Angeles Loneliness Scale
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
The three-item UCLA Loneliness Scale (Hughes et al., 2004) is a widely used instrument for measuring subjective feelings of loneliness. The scale assesses three core dimensions of loneliness through corresponding items: relational connectedness ("How often do you feel that you lack companionship?"), social connectedness ("How often do you feel left out?"), and self-perceived isolation ("How often do you feel isolated from others?"). Participants respond using a 3-point scale ranging from "hardly ever" to "often." Total scores range from 3 to 9, with higher scores indicating greater loneliness. The scale demonstrates good psychometric properties in middle-aged and older adult populations.
Generalized Anxiety Disorder (GAD-7)
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
The GAD-7 is a 7-item questionnaire designed to assess the symptoms of Generalized Anxiety Disorder (GAD). Each item describes a common GAD symptom and is rated on a four-point scale (0-3) based on how often the individual has experienced that symptom over the past 2 weeks. The 7 questions assess feelings such as nervousness, inability to control worrying, trouble relaxing, restlessness, irritability, and feeling afraid. Sample items include, "how often have you felt nervous, anxious, or on edge", "how often have you worried too much about different things", "how often have you had trouble relaxing", and "fFelt afraid as if something awful might happen." Total scores range from 0 to 21, with higher scores indicating increased anxiety severity. Scores are categorized as: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), and 15-21 (severe anxiety).
Patient Health Questionnaire - PHQ-9
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure to assess depressive symptoms in the past 2 weeks (Kroenke et al., 2001). The scale items correspond to the 9 diagnostic criteria for major depressive disorder. Respondents rate the frequency of each symptom on a 4-point scale ranging from "not at all" to "nearly every day." Sample items include "Little interest or pleasure in doing things" and "Poor appetite or overeating." Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. The PHQ-9 includes an additional functional impairment item that assesses how much the problems have affected the respondents' daily activities. The scale has shown strong psychometric properties across diverse populations. Among U.S. older adults, the PHQ-9 showed high sensitivity (88%) and specificity (80%) for identifying major depression, as well as the combination of major and minor depression (Phelan et al., 2010).
Short Form Health Survey (SF-12)
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
The Short Form Health Survey (SF-12) is a self-reported outcome measure to assess health-related quality of life. The raw answers from the 12 questions are processed to produce two main, standardized summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). We only used the MCS factor in this study as the treatment is targeting mental health. The MCS computed score has a range from 17 to 64 in the analysis and was based on the linear combination of six computed, generated, iterated weights. A low Mental Component Summary (MCS) score indicates poorer self-perceived mental health and lower health-related quality of life.
Interpersonal Needs Questionnaire (INQ-15)
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
The Interpersonal Needs Questionnaire (INQ; Van Orden et al., 2012) was used to evaluate thwarted belongingness and perceived burdensomeness through 15 items. We used an adapted version tailored specifically for older adults which includes 3-point Likert scale ranging from 1 (Not at all true for me) to 3 (Very true for me). The instrument includes 2 sets of characteristics: (1) the 9-item Thwarted Belongingness (e.g., "I feel disconnected from other people."); and (2) the 6-item Perceived Burdensomeness (e.g., "I think my death would be a relief to the people in my life."). Six questions from the Thwarted Belongingness subscale were reverse-coded when the overall score across questions was computed due to the nature of those questions. In particular, the total score on the INQ is calculated by summing the questions responses to all items and reversing the appropriate ones. As a result, greater scores on each subscale reflect higher levels of the respective construct being measured.
1 secondary outcome
Session Rating Scale
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundHill, C. E., Knox, S., Thompson, B.J., & Williams, E. N., (1997). A guide to conducting consensual qualitative research. The Counseling Psychologist, 25, 517-572. 44Hill, C. E., Knox, S., Thompson, B. J., Williams, E. N., Hess, S. A., & Ladany, N. (2005). Consensual qualitative research: An update. Journal of Counseling Psychology, 52, 196-205.
- BackgroundEfron, B. (1971). Forcing a sequential experiment to be balanced. Biometrika, 58(3), 403-417.
- BackgroundLang, W. A., Ramsay, R. F., Tanney, B. L., Kinzel, T., Turley, B., & Tierney, R. J. (2013). ASIST trainer manual ( 11th ed.). Calgary, Alberta, Canada: LivingWorks Education.
- BackgroundCaplan, G. (1964). Principles of preventive psychiatry.
- Background: PubMed 26734470Yousefi Z, Sharifi K, Tagharrobi Z, Akbari H. The Effect of Narrative Reminiscence on Happiness of Elderly Women. Iran Red Crescent Med J. 2015 Nov 7;17(11):e19612. doi: 10.5812/ircmj.19612. eCollection 2015 Nov.
- Background: PubMed 34499682Fakoya OA, McCorry NK, Donnelly M. How do befriending interventions alleviate loneliness and social isolation among older people? A realist evaluation study. PLoS One. 2021 Sep 9;16(9):e0256900. doi: 10.1371/journal.pone.0256900. eCollection 2021.
- BackgroundDale M, Fortin MJ. Spatial analysis: a guide for ecologists. Cambridge University Press; 2014.
- BackgroundTseng C, Shao Y. Sample size growth with an increasing number of comparisons. J Probab Stat. 2012;2012:1-10.
- Background: PubMed 19565683Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.
- BackgroundChow SC, Shao J, Wang H, Lokhnygina Y. Sample size calculations in clinical research. Chapman and Hall; 2017.
- BackgroundLohr S, Schochet PZ, Sanders E. Partially Nested Randomized Controlled Trials in Education Research: A Guide to Design and Analysis. NCER 2014-2000. National Center for Education Research; 2014.
- BackgroundFriedman LM, Furberg CD, DeMets DL, Reboussin DM, Granger CB. Fundamentals of clinical trials. Springer; 2015.
- Individual participant dataSharing planned: No. There is no plan to share participant data for several reasons: 1. Ensuring participant privacy: De-identification and secure data management are crucial to protect participant information, 2. Financial resources: Data sharing requires additional resources for data preparation, data sharing agreements, storage, and management which were not included in this grant, 3. Addressing potential biases: Sharing data must be done in a way that minimizes bias and allows for fair and transparent use.
Related trials for Older Adults
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
RecruitingPhase 1
A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures
Focal Seizures
RecruitingObservational study
Validation of the D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Children Aged 8 to 18 Months
Pediatric Feeding Disorder, Feeding Difficulties in Infants and Young Children
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Active, not recruitingPhase 1/2
Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
RSV Infection, Human Metapneumovirus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura R Shannonhouse, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized and manualized warm calls from providers trained in the BE training and standardized and manualized warm calls from providers trained in the BE training + ASIST training in people with Older Adults and Mental Health, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Provisions Scale (SPS-5) (time frame: Baseline, Week 2, Week 4, Week 6 and Week 8). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07204444, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.