Tailoring Overdose Education for Black Churches

Not Applicable

Suspended

• Conditions: Opioid Overdose
• Interventions: Behavioral: COEST

• Registration Number: NCT05645016
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

Church-based interventions are culturally acceptable, reduce access barriers, and can be brought to scale in under-resourced communities. For Overdose Education and Naloxone Distribution (OEND) to be efficacious in Black churches, tailoring may be needed. For this audience, standard OEND curricula may need to be adapted to their level of knowledge of substance use disorders (SUDs), and limited general mental health literacy, and specifically address stigma related to SUDs and medications for opioid use disorder (MOUD). Finally, a tailored implementation strategy may need to address contextual variations (e.g., denomination and membership size) across churches. The proposed pilot study aims to identify the socio-cultural modifications that will be needed to adapt our previously developed training (i.e., COEST) to target Black communities of faith. In a pilot randomized controlled trial (RTC) of adapted COEST in a stepped-wedge design.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-09
• Study Start: 2023-04-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-12-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Identify as one of the following group members of the Black church: Clergy; Individual with OUD and/or stimulant use disorder; Family member or friend of an individual with OUD; Formerly incarcerated.
2. Age 18 and older.

Exclusion Criteria

1. Unable to provide informed consent.
2. Less than 18 years old.
3. Does not identify as belonging to one of the four stakeholder groups.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adapted Comprehensive Overdose Education and Skills Training (COEST)	COEST	-

Primary Outcome Measures

Name	Time	Method
Change in Frequency of Naloxone Utilization/Overdose Intervention	Baseline and 6 Months after COEST training	All study participants will receive an overdose response kit containing two doses of intranasal naloxone. Participants are asked to notify study staff immediately if they utilize naloxone in an attempt to reverse an opioid overdose.

Secondary Outcome Measures

Name	Time	Method
Opioid Overdose Knowledge Scale (OOKS)	Baseline and 6 Months after COEST training	The OOKS measures knowledge about risk factors for having an opioid overdose, signs of an opioid overdose, actions to be taken in an overdose situation, naloxone effects and administration, adverse effects and aftercare procedures. The scale also identifies misinformation. The OOKS is a 14-item scale (Score Range: 0-45).
Brief Opioid Stigma Scale (BOOS)	Baseline and 6 Months after COEST training	The BOSS was developed to assess stereotype awareness ("aware"), stereotype agreement ("agree"), and self-esteem decrement ("harm") surrounding opioid dependence. The BOSS is a 12-item scale (Score Range: 12-60)

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States