Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03977844
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2019-05-30
Brief Title:
Community Resilience Learning Collaborative and Research Network
Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Organization:
Louisiana State University Health Sciences Center in New Orleans
Study Overview
Official Title:
Community Resilience Learning Collaborative and Research Network
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
C-LEARN
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
Detailed Description:
C-LEARNs overall aim is to determine how best to improve resilience particularly mental health-related quality of life for individual adult clients of diverse health and community-social service programs through alternative strategies to build capacity of programs to provide services for depression social risk factors and disaster-related concerns as well as through alternative forms of individual client information technology support for addressing the same range of issues
Specific aims are
To engage communities in South Louisiana in a community learning initiative on how to best build capacity to enhance resilience to depression adverse social determinants of health and disaster exposure This aim includes a qualitative assessment of local community resilience priorities and assets to inform study implementation
To compare the effectiveness for improving mental health quality of life MHRQL primary and coping with stressors and other resilience outcomes secondary of two program-level interventions to build capacity for resilience programs 1 Technical Assistance TA to individual programs vs 2 Community Engagement and Planning CEP to support multi-sector coalitions
To compare the effectiveness for improving MHRQL and other resilience outcomes of two mobile apps CR and CReCBT 1 CR - An app providing only information on community resources or 2 CReCBT - An app providing information on community resources and education on a cognitive behavioral therapy eCBT based approach to enhance individual resilience ie coping with mood and stressors
To describe strategies CEP coalitions used to address depression social determinants and disaster resilience to inform interpretation and dissemination of findings
Design
The design has an overall CPPR approach to implement a 2 by 2 randomized comparative effectiveness trial Randomization occurs at the program level to either CEP or TA where a program is a discrete services program with its own staff and clients there may be multiple programs within a given administrative agency including different geographic sites such as clinics Further programs may offer services in different content areas such as physical health mental health social services disaster services faith-based etc referred to as different sectors In addition individual participants will be randomized to one of two mobile apps for coping with stressors and disasters
The project and design phase has been led by a Leadership Council including academic community and health system participants who have guided all aspects of the study and operate under CPPR principles1 Initial leaders are academic and community partners from the Community and Patient Partnered Research Network CPPRN across South Louisiana and Los Angeles with additional stakeholder advisors from New Orleans Baton Rouge and Coastal South Louisiana planned for as engagement of communities proceeds2 The Council reviews work group recommendations and facilitates larger community input and approval through a stakeholder advisory committee and larger community conferences one of which occurred prior to publishing this phase pre-program recruitment of the protocol
Interventions
The main comparators are CEP and TA Healthcare and community-based programs that are assigned to CEP and TA will both receive training and support for implementation of an expanded model of evidence-based depression collaborative care that also addresses social determinants and disaster readiness The depression toolkits to be used are from studies on adults including racialethnic minority and low-income groups with community health worker manuals from prior work in New Orleans adapted for community-based programs in the Community Partners In Care CPIC study3-7 Toolkits use a team-based stepped-care approach supporting assessment referral and treatment outcomes monitoring and care adjustment with specialty supervision and case managers for coordination and client education While based on components of collaborative care for depression clinical assessment and medication management for physicians clinical assessment and CBT for licensed counselors case management support for screening education and patient activation problem solving care coordination and outreach team management support the interventions will also include resources to address main social determinants eg povertyfinancial planning housing resources and disaster preparednessresponse such as online resources developed after LACCDR8 Initial adaptations have been made with stakeholder input but work groups will continue to refine some materials prior to client recruitment The differences between CEP and TA are described in the following sections
CEP for Coalitions CEP creates multi-sector networks to collaborate in evidence-based and community-prioritized toolkits or intervention materials910 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 principles111 CEP councils consider local context ie cultural assets and stakeholder input Disaster preparedness and public health sectors will be encouraged to offer educationresources 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 811
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 with outside referral for intensive support such as for full supervision in CBT TA provides a series of webinars and as needed primary care site visits focused on team support for assessment treatment support as appropriate with medication andor psychotherapy case management and educational resources and access to intervention toolkits TA experts may include a psychiatrist CBT expert therapist case manager support staff and community leader to engage service programs The team will include experts on components such as financial planning and disaster preparedness
Individual-Level Mobile Apps
C-LEARN will compare two mobile apps created as part of this study referred to as CR and CReCBT that permit interactive text messaging mobile web or interactive voice response IVR interactions using an information technology platform Chorus specifically designed for participatory development2 Each mobile app will be adapted through workgroups with stakeholders in order to tailor content to each community The CR app will primarily provide informational resources and referral information relevant to the local community The study team and investigators will identify resources for depression social determinants and disaster preparedness and response within each community during planning with local stakeholders The CReCBT 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 12 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
Measures and outcomes primarysecondary are identified elsewhere in the clinicaltrialsgov submission Randomization sampling and proposed statistical analysis details are available in the protocol also included with this submission
Part three added during the pandemic consisted of qualitative interviews to assess the impact of the pandemic on organizations and communities in Southeast Louisiana
Human Subjects Protection All procedures will have prior review and approval from the LSU Health Sciences Center-New Orleans LSUHSC-NO Institutional Review Board IRB and partnering research institutions will enter into reliance agreements with LSUHSC-NO The study currently has IRB approval to conduct qualitative interviews and to consent and enroll participating agencies administrators and providers
Specific aims are
To engage communities in South Louisiana in a community learning initiative on how to best build capacity to enhance resilience to depression adverse social determinants of health and disaster exposure This aim includes a qualitative assessment of local community resilience priorities and assets to inform study implementation
To compare the effectiveness for improving mental health quality of life MHRQL primary and coping with stressors and other resilience outcomes secondary of two program-level interventions to build capacity for resilience programs 1 Technical Assistance TA to individual programs vs 2 Community Engagement and Planning CEP to support multi-sector coalitions
To compare the effectiveness for improving MHRQL and other resilience outcomes of two mobile apps CR and CReCBT 1 CR - An app providing only information on community resources or 2 CReCBT - An app providing information on community resources and education on a cognitive behavioral therapy eCBT based approach to enhance individual resilience ie coping with mood and stressors
To describe strategies CEP coalitions used to address depression social determinants and disaster resilience to inform interpretation and dissemination of findings
Design
The design has an overall CPPR approach to implement a 2 by 2 randomized comparative effectiveness trial Randomization occurs at the program level to either CEP or TA where a program is a discrete services program with its own staff and clients there may be multiple programs within a given administrative agency including different geographic sites such as clinics Further programs may offer services in different content areas such as physical health mental health social services disaster services faith-based etc referred to as different sectors In addition individual participants will be randomized to one of two mobile apps for coping with stressors and disasters
The project and design phase has been led by a Leadership Council including academic community and health system participants who have guided all aspects of the study and operate under CPPR principles1 Initial leaders are academic and community partners from the Community and Patient Partnered Research Network CPPRN across South Louisiana and Los Angeles with additional stakeholder advisors from New Orleans Baton Rouge and Coastal South Louisiana planned for as engagement of communities proceeds2 The Council reviews work group recommendations and facilitates larger community input and approval through a stakeholder advisory committee and larger community conferences one of which occurred prior to publishing this phase pre-program recruitment of the protocol
Interventions
The main comparators are CEP and TA Healthcare and community-based programs that are assigned to CEP and TA will both receive training and support for implementation of an expanded model of evidence-based depression collaborative care that also addresses social determinants and disaster readiness The depression toolkits to be used are from studies on adults including racialethnic minority and low-income groups with community health worker manuals from prior work in New Orleans adapted for community-based programs in the Community Partners In Care CPIC study3-7 Toolkits use a team-based stepped-care approach supporting assessment referral and treatment outcomes monitoring and care adjustment with specialty supervision and case managers for coordination and client education While based on components of collaborative care for depression clinical assessment and medication management for physicians clinical assessment and CBT for licensed counselors case management support for screening education and patient activation problem solving care coordination and outreach team management support the interventions will also include resources to address main social determinants eg povertyfinancial planning housing resources and disaster preparednessresponse such as online resources developed after LACCDR8 Initial adaptations have been made with stakeholder input but work groups will continue to refine some materials prior to client recruitment The differences between CEP and TA are described in the following sections
CEP for Coalitions CEP creates multi-sector networks to collaborate in evidence-based and community-prioritized toolkits or intervention materials910 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 principles111 CEP councils consider local context ie cultural assets and stakeholder input Disaster preparedness and public health sectors will be encouraged to offer educationresources 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 811
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 with outside referral for intensive support such as for full supervision in CBT TA provides a series of webinars and as needed primary care site visits focused on team support for assessment treatment support as appropriate with medication andor psychotherapy case management and educational resources and access to intervention toolkits TA experts may include a psychiatrist CBT expert therapist case manager support staff and community leader to engage service programs The team will include experts on components such as financial planning and disaster preparedness
Individual-Level Mobile Apps
C-LEARN will compare two mobile apps created as part of this study referred to as CR and CReCBT that permit interactive text messaging mobile web or interactive voice response IVR interactions using an information technology platform Chorus specifically designed for participatory development2 Each mobile app will be adapted through workgroups with stakeholders in order to tailor content to each community The CR app will primarily provide informational resources and referral information relevant to the local community The study team and investigators will identify resources for depression social determinants and disaster preparedness and response within each community during planning with local stakeholders The CReCBT 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 12 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
Measures and outcomes primarysecondary are identified elsewhere in the clinicaltrialsgov submission Randomization sampling and proposed statistical analysis details are available in the protocol also included with this submission
Part three added during the pandemic consisted of qualitative interviews to assess the impact of the pandemic on organizations and communities in Southeast Louisiana
Human Subjects Protection All procedures will have prior review and approval from the LSU Health Sciences Center-New Orleans LSUHSC-NO Institutional Review Board IRB and partnering research institutions will enter into reliance agreements with LSUHSC-NO The study currently has IRB approval to conduct qualitative interviews and to consent and enroll participating agencies administrators and providers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None