Community Resilience Learning Collaborative and Research Network

NCT03977844 | Completed

• 1 other identifier: 2000008324
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

C-LEARN is designed to determine how to build service program and individual client capacity to improve mental health-related quality of life among individuals at risk for depression, with exposure to social risk factors or concerns about environmental hazards in areas of Southern Louisiana at risk for events such as hurricanes and storms. The study uses a Community Partnered Participatory Research (CPPR) framework to incorporate community priorities into study design and implementation. The first phase of C-LEARN is assessment of community priorities, assets, and opportunities for building resilience through key informant interviews and community agency outreach. Findings from this phase will inform the implementation of a two-level (program-level and individual client level) randomized study in up to six South Louisiana communities. Within communities, health and social-community service programs will be randomized to Community Engagement and Planning (CEP) for multi-sector coalition support or Technical Assistance (TA) for individual program support to implement evidence-based and community-prioritized intervention toolkits, including an expanded version of depression collaborative care and resources (referrals, manuals) to address social risk factors such as financial or housing instability and for a community resilience approach to disaster preparedness and response. Within each arm, the study will randomize individual adult clients to one of two mobile applications that provide informational resources on services for depression, social risk factors, and disaster response or also provide psychoeducation on Cognitive Behavioral Therapy to enhance coping with stress and mood. Planned data collection includes baseline, 6-month and brief monthly surveys for clients, and baseline and 12-month surveys for administrators and staff. Due to COVID-19 pandemic interruption of the study, the recruitment into the randomized controlled trials was halted. A third study part was added to assess the impact of the pandemic on participating study agencies and the community.

Conditions

Depression; Social Stress; Anxiety; Quality of Life; Disaster

Outcome Measures

Primary Outcomes (2)

• Mental Health Related Quality of Life

  Changes in mental health-related quality of life defined by Short Form Survey (SF-12), Mental Health Composite Score (MCS). Survey scored from 0-100 using algorithm for comparison to normative data. Scores interpreted in relation to the normative mean score of 50. \>50 = better mental health quality of life than the mean; \<50 indicates worse physical or mental health quality of life than the mean.

  Baseline and 6 months.

• Depression

  Depression severity defined by the Personal Health Questionnaire-8 (PHQ-8). Each item is scored 0-3 (0= not at all; 3= nearly every day), yielding a possible total between 0 and 24. PHQ-8 score of 10 or greater indicates at least moderate depression. Score of 20 or more indicates likely severe or major depression.

  Baseline and 6 months.

Secondary Outcomes (17)

• Resilience

  Baseline and 6 months.

• Physical Health Related Quality of life

  Baseline to 6 months.

• Mental Wellness Indicator

  Baseline and 6 months.

• Social Determinants of Health

  Baseline and 6 months.

• Behavioral Health Hospitalization

  Baseline and 6 months.

Other Outcomes (6)

• Medication for a mental health disorder

  Baseline and 6 months.

• Barriers to care

  Baseline and 6 months.

• Alcohol use

  Baseline and 6 months.

Study Arms (4)

Technical Assistance

ACTIVE COMPARATOR

Technical Assistance. At the community program level of randomization, community agencies and their staff will be invited to access weekly webinars and toolkits to improve their abilities to support clients' depression care, disaster preparedness and recovery, financial security, and housing security.

Other: Technical Assistance

Community Engagement and Planning

EXPERIMENTAL

Community Engagement and Planning. At the community program level of randomization, community agencies and their staff will be invited to access weekly webinars and toolkits to improve their abilities to support clients' depression care, disaster preparedness and recovery, financial security, and housing security. In addition, community agencies will be invited to meet with one another to develop novel and investigator supported coalitions using principles of community partnered participatory research that will adapt toolkits and other local assets to seek to enhance community resilience related to threats of disaster risk, financial insecurity, housing insecurity, mental health, or other coalition-determined domains.

Other: Technical Assistance; Other: Community Engagement and Planning

Community Resources (CR)

ACTIVE COMPARATOR

Community Resources (CR). At the Individual level of randomization, individuals in the Community Resources (CR) arm will receive access to toolkits and local resources related to depression care, disaster preparedness and recovery, financial security, and housing security.

Other: Community Resources (CR)

Community Resources (CR) + eBT

EXPERIMENTAL

Community Resources + eBT. At the Individual level of randomization, individuals in the CR+eBT arm will receive access to toolkits and local resources related to depression care, disaster preparedness and recovery, financial security, and housing security, along with an interactive component to support CBT-informed coping with mood and stressors at the individual level.

Other: Community Resources (CR); Other: Community Resources + eBT

Interventions

Technical Assistance OTHER

TA for Individual Programs TA uses experts to train program staff via webinars and site visits, using the same toolkits as CEP, in a "train the trainer" approach. TA provides a series of webinars and as needed site visits, focused in the example of depression care on team support for assessment, treatment support as appropriate with medication and/or psychotherapy, case management and educational resources and access to intervention toolkits. It also includes webinars and training toolkits for agencies on domains of social risk factors for health (financial security and housing security) as well as disaster preparedness and recovery.

Community Engagement and Planning; Technical Assistance

Community Engagement and Planning OTHER

CEP for Coalitions CEP creates multi-sector networks to collaborate in evidence-based and community-prioritized toolkits or intervention materials. CEP supports a series of biweekly to monthly meetings to develop network and individual program capacity, prepare stakeholders as co-leads, and create a written training plan following CPPR principles \[48, 64\]. CEP councils consider local context, i.e., cultural assets and stakeholder input. Disaster preparedness and public health sectors will be encouraged to offer education/resources on social determinants and disasters within CEP training plans. CEP will be supported by a Learning Collaborative, meeting 2-3 times, using activities such as project examples, tabletop exercises and self-assessment to identify gaps and formulate goals for improvement.

Community Engagement and Planning

Community Resources (CR) OTHER

The CR app will primarily provide informational resources and referral information relevant to the local community. We will identify resources for depression, social determinants and disaster preparedness and response within each community during planning with local stakeholders.

Community Resources (CR); Community Resources (CR) + eBT

Community Resources + eBT OTHER

The CR+eCBT app consists of the functionality of the CR app along with an interactive component to support CBT-informed coping with mood and stressors at the individual level. This component was developed previously by our group using participatory methods with community partners and includes interactive support to enhance social support networks, support cognitive restructuring (framed through partnered input as "Catch it, Check it, Change it"), and encourage pleasant activities \[65\]. Participants will receive text message notifications (with frequency set by participants, up to several times per day) and can either reply back to messages to explore content or click a link in the message to access the interactive mobile app.

Community Resources (CR) + eBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• English reading and writing fluency
• Resident of Southeast Louisiana
• Employed at a participating community agency
• years of age or older
• English fluency in reading and writing
• Resident of Southeast Louisiana
• Client of a participating community agency
• Access to a phone that receives SMS text messages
• (PHQ-8 ≥ 10 OR MCS-12 ≤ 40) OR
• (Disaster exposure AND housing insecurity) OR
• (Disaster exposure AND financial insecurity)

You may not qualify if:

• Grossly intoxicated
• Mentally incapacitated

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• National Academies of Sciences - Gulf Research Program: collaborator
• University of California, Los Angeles: collaborator
• University of Southern California: collaborator

Study Sites (1)

Lsuhsc-No

New Orleans, Louisiana, 70112, United States

Location

Related Publications (5)

• Springgate BF, Arevian AC, Wennerstrom A, Johnson AJ, Eisenman DP, Sugarman OK, Haywood CG, Trapido EJ, Sherbourne CD, Everett A, McCreary M, Meyers D, Kataoka S, Tang L, Sato J, Wells KB. Community Resilience Learning Collaborative and Research Network (C-LEARN): Study Protocol with Participatory Planning for a Randomized, Comparative Effectiveness Trial. Int J Environ Res Public Health. 2018 Aug 7;15(8):1683. doi: 10.3390/ijerph15081683.

  PMID: 30720791 BACKGROUND

• Acosta JD, Augustine LA, Birch TL, et al. Strengthening the Response to Disasters and Trauma. In: Plough AL, ed. Community Resilience. Oxford University Press; 2021:140-153. doi:10.1093/oso/9780197559383.003.0012

  BACKGROUND

• Palinkas LA, Springgate BF, Sugarman OK, Hancock J, Wennerstrom A, Haywood C, Meyers D, Johnson A, Polk M, Pesson CL, Seay JE, Stallard CN, Wells KB. A Rapid Assessment of Disaster Preparedness Needs and Resources during the COVID-19 Pandemic. Int J Environ Res Public Health. 2021 Jan 7;18(2):425. doi: 10.3390/ijerph18020425.

  PMID: 33430355 RESULT

• Everett A, Sugarman O, Wennerstrom A, et al. Community-informed strategies to address trauma and enhance resilience in climate-affected communities. Traumatology. 2020;26(3):285-297. doi:10.1037/trm0000225

  RESULT

• Pollock MJ, Wennerstrom A, True G, Everett A, Sugarman O, Haywood C, Johnson A, Meyers D, Sato J, Wells KB, Arevian AC, Massimi M, Berry J, Riefberg L, Onyewuenyi N, Springgate B. Preparedness and Community Resilience in Disaster-Prone Areas: Cross-Sectoral Collaborations in South Louisiana, 2018. Am J Public Health. 2019 Sep;109(S4):S309-S315. doi: 10.2105/AJPH.2019.305152.

  PMID: 31505147 RESULT

Related Links

• The official webpage for the C-LEARN study. Includes intervention materials, additional academic publications, presentations, and more.

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Health Planning Technical Assistance; Community Resources

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations

Study Officials

• Benjamin Springgate, MD

  LSUHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Client-level participants are unaware of which arm to which the agencies from which they have been recruited have been assigned at the community agency level randomization. Providers are unaware of which clients have been recruited into the study, as well as to which arm the clients have been assigned at the individual level randomization for the technological mobile phone intervention. Outcomes assessors at follow-up assessments are unaware of which arm the participants have been assigned at either the community or individual level.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Community agencies are randomized to participate in either of two intervention arms. Clients recruited at agencies in either community-level intervention arm are randomized at individual level to participate in one of two technology interventions. 2 arms at community level of randomization, 2 arms at individual level of randomization.

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 6, 2019
• Study Start: November 11, 2019
• Primary Completion: July 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)