NCT06093737

Brief Summary

The goal of this clinical trial is to examine the impact of the Communities Organizing for Power through Empathy (COPE) intervention in adults in communities having recently experienced or at risk of experiencing disaster. The main questions it aims to answer are:

  • How does the COPE intervention affect individual mental health?
  • How does the COPE intervention affect protective factors like coping and social support?
  • How does the COPE intervention affect community resilience?
  • How does delivery of the COPE intervention in partnership with a broad-based organization affect participant recruitment and retention, as well as outcomes? Participants will participate in the three session COPE intervention. Researchers will compare individuals who participate in the COPE intervention to individuals who participate in house meetings to see if the COPE intervention improves mental health, coping, social support and community resilience. Researchers will also examine factors that affect implementation and intervention delivery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

2.2 years

First QC Date

October 12, 2023

Last Update Submit

October 17, 2023

Conditions

Keywords

mental healthcommunity-based participatory researchemotional wellbeingperceived stress

Outcome Measures

Primary Outcomes (7)

  • Change in perceived stress from baseline

    Measured using Perceived Stress Scale, a 10-item scale that measures the degree to which a person appraises situations in their life as stressful.

    T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)

  • Change in depression symptoms from baseline

    Measured using The Depression, Anxiety, and Stress Scale (DASS), a set of three self-report scales designed to measure depression, anxiety and stress.

    T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)

  • Change in anxiety symptoms from baseline

    Measured using The Depression, Anxiety, and Stress Scale (DASS), a set of three self-report scales designed to measure depression, anxiety and stress.

    T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)

  • Change in stress symptoms from baseline

    Measured using The Depression, Anxiety, and Stress Scale (DASS), a set of three self-report scales designed to measure depression, anxiety and stress.

    T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)

  • Change in perceived social support from baseline

    Measured using the Multidimensional Scale of Perceived Social Support (MSPSS) is a 12 item scale, assessing perceived social support and connection.

    T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)

  • Change in coping from baseline

    Measured using the Coping Self-Efficacy Scale (CSES) short form, a 12-item measure of confidence in managing stressors.

    T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)

  • Change in community resilience from baseline

    Measured using the Communities Advancing Resilience Toolkit (CART), a 21-item measure of community resilience items across 4 interrelated domains that both reflect and contribute to community resilience: (1) Connection and Caring; (2) Resources; (3) Transformative Potential; and (4) Disaster Management.

    T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)

Secondary Outcomes (3)

  • Intervention acceptibility

    After delivery of 3rd session

  • Intervention appropriateness

    After delivery of 3rd session

  • Intervention feasibility

    After delivery of 3rd session

Other Outcomes (3)

  • Interviews

    From date of first intervention delivery until 3 months post-date of delivery of final intervention session

  • Focus groups

    From date of first intervention delivery until 3 months post-date of delivery of final intervention session

  • Intervention fidelity

    At each intervention session.

Study Arms (2)

COPE Intervention

EXPERIMENTAL

Is a three session brief group psychoeducational intervention. Session 1 is 4 hours, Session 2 and 3 are 1.5 hours. It is delivered in groups of 8-15 people with sessions spaced 1 month apart.

Behavioral: COPE: Communities Organizing for Power through Empathy

House Meeting Control

ACTIVE COMPARATOR

Is a 1.5 hour group meeting delivered in groups of 8-15 people spaced 1 month apart.

Behavioral: COPE: Communities Organizing for Power through Empathy

Interventions

A three session brief group psychoeducational intervention. Session 1 is 4 hours, Session 2 and 3 are 1.5 hours. It is delivered in groups of 8-15 people with sessions spaced 1 month apart.

COPE InterventionHouse Meeting Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals 18 years of age or older who are staff or members of an organization that is part of Together Baton Rouge and who participate in the intervention or are/were involved in the adaptation or implementation of the brief intervention in any capacity

You may not qualify if:

  • Persons who are not 18 years of age or older and persons who are not staff or members of an organization that is part of Together Baton Rouge and/or not involved with the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Together Baton Rouge

Baton Rouge, Louisiana, 70802, United States

RECRUITING

Related Publications (1)

  • Scott J, Powell T, Lee-Johnson NM. The Communities Organizing for Power Through Empathy (COPE) Community-Based Intervention to Improve Adult Mental Health During Disasters and Crises: Protocol for a Stepped-Wedge Cluster Randomized Trial. JMIR Res Protoc. 2025 May 20;14:e63723. doi: 10.2196/63723.

MeSH Terms

Conditions

Psychological Well-BeingAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorMental DisordersBehavioral Symptoms

Study Officials

  • Jennifer L Scott, PhD, LCSW

    Louisiana State University Health Sciences Center in New Orleans

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer L Scott, PhD, LCSW

CONTACT

Tara L Powell, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 23, 2023

Study Start

March 25, 2023

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations