Contemporary clinical trials · 2025
The Grief Navigation Trial: A multi-site pragmatic comparative effectiveness trial of two interventions to support parents after their child's unexpected or traumatic death.
СтатьяПротокол клинического исследованияПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Agha Elaf, Sutter Carolyn, Ojewuyi Ifeoluwadolapo, Abramsohn Emily M, Andriano Megan, Bell Christal, Calix Anna L, Cherry Jamie Lynn, Downing Kim, Flower Tina, Halm Michelle, Hayes Ashley, Heffernan Marie E, Hill JaShawn, Hoeppner C Zoe, Jacobson Meghan, Jennings Jacquelyn, Kula-Leitner Leslie, Lee SuYeon, Major Deborah R, Makelarski Jennifer A, Maruyama Nancy L, McNicholas Amy, Newton Steve, Shuber Charlotte, Vesco Anthony T, Lindau Stacy Tessler, Michelson Kelly N, Grief Navigation Trial Study Team
Аннотация
BACKGROUND: In the US, ~60,000 people <25 years old die annually. Forty-five percent of pediatric deaths occur traumatically, and the parents' or caregivers' (hereafter 'parents') sole contact with the healthcare system is often the coroner or medical examiner (ME). Parents experience mental and physical health problems following their child's death. There are no evidence-based interventions for MEs supporting bereaved parents. Scalable, systems-level interventions are needed to connect bereaved parents to grief and social care support. This research will build upon the experience of Missing Pieces, a community organization that supports families after pediatric death, and CommunityRX, an evidence-based social care intervention that supports patients and caregivers. This comparative effectiveness trial will test two strategies that help parents and caregivers find support after traumatic or unexpected pediatric death.
METHODS: This pragmatic, comparative effectiveness randomized controlled trial uses a hybrid type 1 implementation-effectiveness design to compare: (1) CommunityRx-Bereavement (the "high touch" intervention), a personalized resource referral intervention involving Grief Navigator support; and (2) general bereavement support information (the "low touch" intervention), including community resources, shared by text message. Parents of deceased children (<25 years old) are referred by MEs to Missing Pieces and cases are randomized. The primary outcomes are complicated grief and self-efficacy for finding resources, evaluated ~6.5 months post-child's death. By taking a community-engaged research approach, community collaborators were included to inform research methods, materials, and dissemination plans.
DISCUSSION: This work fills a knowledge gap regarding evidence-based practices for supporting families after the traumatic or unexpected death of their child.
TRIAL REGISTRATION: NCT06136260.
METHODS: This pragmatic, comparative effectiveness randomized controlled trial uses a hybrid type 1 implementation-effectiveness design to compare: (1) CommunityRx-Bereavement (the "high touch" intervention), a personalized resource referral intervention involving Grief Navigator support; and (2) general bereavement support information (the "low touch" intervention), including community resources, shared by text message. Parents of deceased children (<25 years old) are referred by MEs to Missing Pieces and cases are randomized. The primary outcomes are complicated grief and self-efficacy for finding resources, evaluated ~6.5 months post-child's death. By taking a community-engaged research approach, community collaborators were included to inform research methods, materials, and dissemination plans.
DISCUSSION: This work fills a knowledge gap regarding evidence-based practices for supporting families after the traumatic or unexpected death of their child.
TRIAL REGISTRATION: NCT06136260.