The BE WITH Project: A Partially Nested Randomized Control Trial (PN-RCT)
NCT ID: NCT07204444
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
671 participants
INTERVENTIONAL
2021-06-01
2024-10-25
Brief Summary
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1. 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?
2. 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)?
3. 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:
1. answer questions from a trained data collector to get their baseline,
2. 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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BE Condition
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
standardized and manualized warm calls from providers trained in the BE training
Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
BE + ASIST Condition
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)
standardized and manualized warm calls from providers trained in the BE training + ASIST training
Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
Control
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.
No interventions assigned to this group
Interventions
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standardized and manualized warm calls from providers trained in the BE training
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 training
Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
Eligibility Criteria
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Inclusion Criteria
2. Classify as an Older Adult (55+),
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)), and
5. Be affiliated with one of the 25 senior centers we will contract with through a Memorandum of Understanding.
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 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
5. Be recommended by the senior center leadership as meeting these qualifications.
Exclusion Criteria
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.
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), and
2. Participation in another warm calling behavioral treatment or intervention study simultaneously occurring in this state.
55 Years
ALL
Yes
Sponsors
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Georgia State University
OTHER
Department of Health and Human Services
FED
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Laura R Shannonhouse, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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Older Adults' Homes; Treatment Provided Over the Phone
Atlanta, Georgia, United States
Countries
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References
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Other Identifiers
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90INNU0021
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
90INNU0021-03-00
Identifier Type: -
Identifier Source: org_study_id