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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
University of Florida
Study ID
NCT07204444
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • standardized and manualized warm calls from providers trained in the BE training — BEHAVIORAL
    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 — BEHAVIORAL
    Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration

Study Details

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.

Key Dates

Start date
Jun 1, 2021
Status verified
Jun 2025
Primary completion
Oct 25, 2024
Completion
Oct 25, 2024

Study Design

Enrollment
671 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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)
  • No Intervention: 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.

Primary Outcome Measure

Social Provisions Scale (SPS-5) [ Time Frame: Baseline, Week 2, Week 4, Week 6 and Week 8 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Older Adults' Homes; Treatment Provided Over the PhoneAtlantaGeorgia30318-

Find similar trials in Atlanta, GA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Older Adults' Homes; Treatment Provided Over the Phone· Atlanta, GA

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