Tailoring Overdose Education for Black Churches

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05645016

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Overdose	Behavioral: COEST	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The design is a two-arm cluster randomized trial with randomization at the level of the church (4 Churches), and analyses at the level of the individual participants (i.e., church members).The design is a two-arm cluster randomized trial with randomization at the level of the church (4 Churches), and analyses at the level of the individual participants (i.e., church members).

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Church-Tailored Opioid Overdose Education and Naloxone Distribution to Target Overdose and Stigma Among African-American Communities

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2025

Anticipated Study Completion Date :

Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adapted Comprehensive Overdose Education and Skills Training (COEST)	Behavioral: COEST Adapted version of our COEST training, targeting Black church members.

Arm

Intervention/Treatment

Experimental: Adapted Comprehensive Overdose Education and Skills Training (COEST)

Behavioral: COEST

Adapted version of our COEST training, targeting Black church members.

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.
Age 18 and older.

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

New York State Psychiatric Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jermaine D. Jones, Associate Professor of Clinical Neurobiology, New York State Psychiatric Institute

ClinicalTrials.gov Identifier:

NCT05645016

Other Study ID Numbers:

8208

First Posted:

Dec 9, 2022

Last Update Posted:

Dec 9, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Drug Overdose

Opiate Overdose

Study Results

No Results Posted as of Dec 9, 2022