COPE: Strengthening Community Mental Health

Sponsor
Louisiana State University and A&M College (Other)
Overall Status
Recruiting
CT.gov ID
NCT06093737
Collaborator
National Academies of Sciences, Engineering and Medicine (Other), University of Illinois at Urbana-Champaign (Other)
300
1
2
26.3
11.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: COPE: Communities Organizing for Power through Empathy
N/A

Detailed Description

This Community-Based Participatory Research (CBPR) study will follow a multiphase mixed-methods design to adapt, deliver, and assess the efficacy of the Communities Organizing for Power through Empathy (COPE) intervention model. We will partner with a broad-based community organization, Together Baton Rouge, to adapt the intervention model to fit the context of East Baton Rouge Parish (EBRP) and deliver it to members of religious and non-profit institutions.

The objectives of the multi-level COPE intervention model are twofold: (1) reduce psychological distress and amplify protective factors among individuals and communities at risk of experiencing disasters; and (2) build individual and community psychological support response capacity. The intervention will be delivered by trained Community Facilitators (CFs) at community institutions (i.e., churches) to their institutional members. We will conduct a stepped wedge cluster randomized controlled trial (SWCRCT) to examine the impact of the COPE intervention. Measures of mental health, coping, social support and community resilience will be assessed at four timepoints (see timeline for data collection timepoints). We will conduct interviews and group reflections with CFs and participants to gain insight into their experiences with the intervention.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Reducing Disparities in Disaster-Related Mental Health Burden: Adaptation of a Multi-level Intervention to Build Community-based Response Capacity
Actual Study Start Date :
Mar 25, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: COPE Intervention

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
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.

Active Comparator: House Meeting Control

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
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.

Outcome Measures

Primary Outcome Measures

  1. Change in perceived stress from baseline [T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)]

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

  2. Change in depression symptoms from baseline [T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)]

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

  3. Change in anxiety symptoms from baseline [T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)]

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

  4. Change in stress symptoms from baseline [T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)]

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

  5. Change in perceived social support from baseline [T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)]

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

  6. Change in coping from baseline [T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)]

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

  7. Change in community resilience from baseline [T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)]

    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.

Secondary Outcome Measures

  1. Intervention acceptibility [After delivery of 3rd session]

    Measured using the Acceptability of Intervention Measure (AIM), a 4 item measure of agreement with intervention.

  2. Intervention appropriateness [After delivery of 3rd session]

    Measured using the Appropriateness Measure (IAM), a 4 item measure of agreement with the appropriateness of the intervention.

  3. Intervention feasibility [After delivery of 3rd session]

    Measured using the Feasibility of Intervention Measure (FIM), a 4 item measure of agreement with the feasibility of implementing the intervention.

Other Outcome Measures

  1. Interviews [From date of first intervention delivery until 3 months post-date of delivery of final intervention session]

    Semi-structured interviews about experience with participating in or facilitating the intervention

  2. Focus groups [From date of first intervention delivery until 3 months post-date of delivery of final intervention session]

    Periodic reflections conducted with community facilitators.

  3. Intervention fidelity [At each intervention session.]

    Assessed via facilitator observation using a structured fidelity questionnaire/form.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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
Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Together Baton Rouge Baton Rouge Louisiana United States 70802

Sponsors and Collaborators

  • Louisiana State University and A&M College
  • National Academies of Sciences, Engineering and Medicine
  • University of Illinois at Urbana-Champaign

Investigators

  • Principal Investigator: Jennifer L Scott, PhD, LCSW, Louisiana State University Health Sciences Center in New Orleans

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jennifer Lauren Scott, Associate Professor, Louisiana State University and A&M College
ClinicalTrials.gov Identifier:
NCT06093737
Other Study ID Numbers:
  • IRBAM-21-139105
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jennifer Lauren Scott, Associate Professor, Louisiana State University and A&M College
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023