The BE WITH Project: A Partially Nested Randomized Control Trial (PN-RCT) (BE_WITH)

University of Florida

Status: Completed

Conditions: Thwarted Belongingness; Help-Seeking Behavior; Suicide Ideations; Suicide Risk; Loneliness; Older Adults; Social Functioning; Social Isolation; Perceived Burdensomeness; Mental Health; Quality of Life; Depression

Treatments: Behavioral: standardized and manualized warm calls from providers trained in the BE training + ASIST training; Behavioral: standardized and manualized warm calls from providers trained in the BE training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07204444

90INNU0021 (Other Grant/Funding Number)

90INNU0021-03-00

Details and patient eligibility

About

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. 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.

Full 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.

Enrollment: 671 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for older adult participants:

1. Provision of verbal informed consent,
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.

Inclusion Criteria for trained providers:

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 for older adult participants:

1. Had a dementia diagnosis, or another form of cognitive impairment, and/or hearing impairment that would preclude phone conversation, and
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 helpers:

1. Does not have ongoing interactions with potential old adult participants (i.e. is a part of an optimized nutrition service provider in which they do not serve the same older adults consistently over time), and
2. Participation in another warm calling behavioral treatment or intervention study simultaneously occurring in this state.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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671 participants in 3 patient groups

BE Condition

Experimental group

Description:

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

Treatment:

Behavioral: standardized and manualized warm calls from providers trained in the BE training

BE + ASIST Condition

Experimental group

Description:

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)

Treatment:

Behavioral: standardized and manualized warm calls from providers trained in the BE training + ASIST training

Control

No Intervention group

Description:

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.