The BE WITH Project: A Partially Nested Randomized Control Trial (PN-RCT) (NCT07204444) | Clinical Trial Compass
CompletedNot Applicable
The BE WITH Project: A Partially Nested Randomized Control Trial (PN-RCT)
United States671 participantsStarted 2021-06-01
Plain-language 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. 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.
Who can participate
Age range55 Years
SexALL
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Inclusion criteria
✓. 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,
✓. 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,
Exclusion criteria
✕. 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.
✕. 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.