Scaling up e-Connect in Juvenile Probation Settings
Primary Purpose
Suicide
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
e-Connect
Sponsored by
About this trial
This is an interventional prevention trial for Suicide
Eligibility Criteria
Sample: County Probation Staff
Inclusion Criteria:
- All probation agency leadership and officers employed by the partnering sites who are (a) at least 18 years of age and (b) conversant in English in participating study counties are eligible
Exclusion Criteria:
- There are no exclusionary criteria and no special classes of participants.
Sample: County Treatment Staff
Inclusion Criteria:
- All treatment staff (agency directors, supervisors and clinical line staff) employed by participating treatment agencies who are at least 18 years of age and conversant in English in participating study counties will be asked to participate
Exclusion Criteria:
- There are no exclusionary criteria and no special classes of participants.
Sample: Local Facilitators
Inclusion Criteria:
- All county/local Justice Diversion Alternatives Initiative (JDAI) representatives that work with partnering sites who (a) are at least 18 years of age and (b) conversant in English in participating study counties are eligible
Exclusion Criteria:
- There are no exclusionary criteria and no special classes of participants.
Sample: Probation Youth
Inclusion Criteria:
- All youth who are on probation who are (a) 10-18 years of age and (b) conversant in English in participating study counties are eligible;
Exclusion Criteria:
- There are no exclusionary criteria and no special classes of participants.
Sites / Locations
- Columbia University and New York State Psychiatric Instititute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
e-Connect
Standard of Care
Arm Description
County receives training and materials and subsequently begins the e-Connect intervention
Standard of care practice in counties prior to the implementation of e-Connect
Outcomes
Primary Outcome Measures
Treatment initiation
Date of first behavioral health appointment/contact; extracted from Indiana Probation management information system (MIS)
Secondary Outcome Measures
Treatment engagement
# of weeks in treatment, via termination date; extracted from MIS, Medicaid data
Screen/Identify Youth Service Need
Via e-Connect system and recorded in Caseload Explorer: YASI Orbis, Chestnut Information indicates whether screening has occurred; Extracted from MIS
Cross-system Referral
Indicated by Referral Date; extracted from MIS
Uptake Adoption of e-Connect system
Acceptability, uptake and sustainability of e-Connect (BH and JJ staff; External and Local facilitators
Uptake Adoption - MIS
Number of eligible youth screened via e-Connect
Fidelity to use of e-Connect system
Measured by Stages of Implementation Completion (SIC) tool. indicated by implementation stages complete; time to stage completion; activities completed w/in each stage)
Fidelity of Facilitation
Checklists (self and observer) documenting completeness of activities; External/Local Facilitation activity tracker
Acceptability of e-Connect by the family
PO completes family debriefing checklist: family receptivity to screening results and referral plan
Sustainability of e-Connect protocol
Measured using MIS
Sustainability achieved in implementation process
Stages of Implementation Completion (SIC) tool measures - Implementation stages complete; time to stage completion; activities completed within each stage measured by the SIC tool
Full Information
NCT ID
NCT05541926
First Posted
September 9, 2022
Last Updated
August 15, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
Indiana University School of Medicine, George Mason University, Chestnut Health Systems, National Institute of Mental Health (NIMH), Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT05541926
Brief Title
Scaling up e-Connect in Juvenile Probation Settings
Official Title
Scaling up eConnect in Juvenile Probation Settings: a Hybrid Implementation Effectiveness Trial of a Digital Suicide Risk/Behavior Identification and linkage-to Treatment System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Indiana University School of Medicine, George Mason University, Chestnut Health Systems, National Institute of Mental Health (NIMH), Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We propose to conduct research on strategies that support the successful scale-up of an evidence-based, suicidal risk and behavior identification and cross-system linkage programs for justice-involved youth (e-Connect), and to rigorously evaluate the implementation activities and associated costs that support that scale-up of e-Connect within 9 Indiana counties. Guided by the GPM and EPIS frameworks, this 4-year study will comprise 3 project phases: (1) Scale-Up Strategy Efforts, focused on preparing for scale-up; (2) e-Connect-scaleup implementation (2a Exploration and Preparation and 2b Implementation and Sustainment); and (3) Scale-Up Effectiveness Trial/Outcome Evaluation. The current project draws on lessons learned from the e-Connect efficacy trial in NYS and research team leadership will serve as External Facilitators to support 9 Local Facilitators to ensure the successful transfer of knowledge, skill and expertise in delivering e-Connect in a new JJ system and geographic context, utilizing implementation strategies to support the more widespread, sustained and rigorous adoption of e-Connect. The study will include a learning community created by External Facilitators for Local Facilitators to provide support, to exchange strategies to handle implementation issues, to develop competencies in facilitation, and to guide implementation throughout the program. The learning community will help Local Facilitators navigate through the implementation stages of the study.
Detailed Description
The proposed study will examine strategies to bolster the successful scale-up of e-Connect, one of the few evidence-based suicide behavior identification and cross-system linkage programs for youth on under community supervision. This proposal is from two PIs with complimentary expertise in the justice system, implementation science, clinical decision support systems, and use of large administrative data sets, and is supported by a strong multi-disciplinary team to achieve study aims. Guided by the gateway provider model (GPM) and the Exploration, Preparation, Implementation Sustainment (EPIS) implementation framework, we now propose to extend our work of e-Connect, to develop and test a "purveyor model" of implementation scale-up (i.e. e-Connect-scaleup). In e-Connect-scaleup, research team leadership will serve as External Facilitators to support Local Facilitators to ensure the successful transfer of knowledge, skill and expertise in delivering e-Connect in a new JJ system and geographic context, utilizing implementation strategies to support the more widespread, sustained and rigorous adoption of e-Connect. Working in 9 Indiana counties, randomly assigned to one of three waves in a stepped-wedge, implementation-effectiveness hybrid type-2 design, the specific aims are to examine the clinical and cost-effectiveness of e-Connect-scaleup on (i) identification of youth service need (SB and BH correlates) in juvenile probationers; (ii) cross-system (probation-BH agency) referral; and (iii) youth BH service use (initial BH contact; primary outcome) by comparing the performance of e-Connect to (a) standard probation officer practice (baseline) and (b) to rates achieved in the prior efficacy trial of e-Connect (Aim 1). We will examine potential mediating or moderating effects of EPIS/GPM inner and outer context factors We will also determine whether, at scale, e-Connect can reduce race or gender health disparities in SB/BH service need identification, cross-system referral and youth SB/BH service use (e.g. as compared to standard probation practice (baseline), which would replicate the disparity-reducing performance of e-Connect in NYS (Aim 2). Finally, we will examine the implementation of e-Connect-scaleup in terms of fidelity and acceptability and compare advancement through the stages of implementation through to sustainment across the 9 counties in order to demonstrate the feasibility of scaling-up e-Connect in probation settings beyond NYS (Aim 3). We will elucidate the inner- and outer-level EPIS- and GPM- derived factors that promote or hinder delivery of implementation strategies and practice change to inform scale up across a variety of contexts.
Settings. The sample for the proposed study will be recruited from probation staff, partnering treatment agency staff, and probation youth from 9 counties in Indiana, which are distributed across the state geographically. The counties range in population density, with 5 qualifying as Rural/Mixed and 4 as Urban. Each county participating in the proposed study is also a member of the Indiana Juvenile Detention Alternatives Initiative, a nationwide juvenile justice reform effort funded by the Annie E. Casey Foundation and adopted in nearly a third of Indiana counties. The focus of JDAI is to limit the unnecessary detainment of low-risk probation youth. Each JDAI county has developed committees of staff and community members that use a data-driven process, one of the JDAI core strategies, to identify targets of intervention, assess effectiveness of the interventions, and continue monitoring progress to develop future interventions. Recognizing the benefits of JDAI, Indiana was the second state to institute a central JDAI office to support statewide expansion. Each JDAI county has a dedicated coordinator who will also act as Local Facilitator for e-Connect. See the map indicating the location of participating sites relative to other JDAI counties and juvenile detention centers.
Design, Sample Size and Randomization. In the proposed cluster randomized stepped-wedge design, 9 Indiana counties will be randomized - stratified by population density/urbanicity (as a proxy for staffing and resource availability) - to one of 3 waves of e-Connect-scale-up at 3-month intervals.
We will examine the clinical and cost-effectiveness of e-Connect-scaleup on (i) identification of youth service need (SB and BH correlates) in juvenile probationers; (ii) cross-system (probation-BH agency) referral; and (iii) youth BH service use (initial BH contact; primary outcome) by comparing the performance of e-Connect to (a) standard probation officer practice (baseline) and (b) to rates achieved in the prior efficacy trial of e-Connect (Aim 1). We will examine potential mediating or moderating effects of EPIS/GPM inner (e.g. staff knowledge, organizational functioning) and outer context factors (e.g. youth age, county rate of SB) on e-Connect-scaleup outcomes. We will also determine whether, at scale, e-Connect can reduce race or gender health disparities in SB/BH service need identification, cross-system referral and youth SB/BH service use (e.g. as compared to standard probation practice (baseline), which would replicate the disparity-reducing performance of e-Connect in NYS (Aim 2). Finally, we will evaluate the implementation of e-Connect-scaleup in two ways (Aim 3). First, we will examine the fidelity and acceptability of e-Connect-scaleup, including facilitation strategies. Second, we will document processes of scaling up e-Connect, comparing advancement through the stages of implementation through to sustainment across the 9 counties in order to demonstrate the feasibility of scaling-up e-Connect in probation settings beyond NYS; we will explore the role of site differences and other EPIS and GPM factors on implementation completion (Aim 3). By randomizing sites to e-Connect-scaleup across time, the control group (which is changing over time) is taken to be the sites that have not yet rolled out e-Connect-scaleup by a particular time, treatment as usual (TAU). Data on these behavioral health care cascade outcomes are collected in each county pre and post randomization to e-Connect-scaleup allowing for within site estimates of change while controlling for secular changes over time. We will also examine potential effect modifiers of e-Connect by youth, staff and county level inner and outer setting factors. To examine impact and success of implementation strategies, we will compare stages of implementation completion as well as feasibility and acceptability cross the 9 new counties, exploring the role of site differences as well as other EPIS factors (outer-, inner-context level) on implementation completion. There are two limitations to cluster randomized deigns: potential of uneven distribution of potentially confounding variables within a cluster (i.e. county) as well as interrelationship between variables. Our proposed stratification plan and use of propensity matching will address issues related to confounding. We calculated our ability to detect an effect of e-Connect-scaleup (i.e. power) using a conservative intraclass correlation coefficient (ICC) of .65, denoting a moderate-large positive correlation between outcomes within a county to address issues of interrelationship between variables at the county level.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Stepped-wedge design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3629 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
e-Connect
Arm Type
Experimental
Arm Description
County receives training and materials and subsequently begins the e-Connect intervention
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of care practice in counties prior to the implementation of e-Connect
Intervention Type
Behavioral
Intervention Name(s)
e-Connect
Intervention Description
Implementation of the e-Connect system
Primary Outcome Measure Information:
Title
Treatment initiation
Description
Date of first behavioral health appointment/contact; extracted from Indiana Probation management information system (MIS)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Treatment engagement
Description
# of weeks in treatment, via termination date; extracted from MIS, Medicaid data
Time Frame
3 years
Title
Screen/Identify Youth Service Need
Description
Via e-Connect system and recorded in Caseload Explorer: YASI Orbis, Chestnut Information indicates whether screening has occurred; Extracted from MIS
Time Frame
3 years
Title
Cross-system Referral
Description
Indicated by Referral Date; extracted from MIS
Time Frame
3 years
Title
Uptake Adoption of e-Connect system
Description
Acceptability, uptake and sustainability of e-Connect (BH and JJ staff; External and Local facilitators
Time Frame
6 months
Title
Uptake Adoption - MIS
Description
Number of eligible youth screened via e-Connect
Time Frame
3 years
Title
Fidelity to use of e-Connect system
Description
Measured by Stages of Implementation Completion (SIC) tool. indicated by implementation stages complete; time to stage completion; activities completed w/in each stage)
Time Frame
3 years
Title
Fidelity of Facilitation
Description
Checklists (self and observer) documenting completeness of activities; External/Local Facilitation activity tracker
Time Frame
3 years
Title
Acceptability of e-Connect by the family
Description
PO completes family debriefing checklist: family receptivity to screening results and referral plan
Time Frame
3 years
Title
Sustainability of e-Connect protocol
Description
Measured using MIS
Time Frame
1 year, 4 months
Title
Sustainability achieved in implementation process
Description
Stages of Implementation Completion (SIC) tool measures - Implementation stages complete; time to stage completion; activities completed within each stage measured by the SIC tool
Time Frame
1 year, 4 months
Other Pre-specified Outcome Measures:
Title
Suicidal Behavior, Non-Suicidal Self-Injury (NSSI), BH knowledge
Description
Measured during pre-post quizzes following web-based training modules; developed for study
Time Frame
3 years
Title
Perceived importance of screening and referral to BH - Exploration Phase services
Description
Subscales for screening - Measure assessing perceived importance of activities associated with screening, referral and linkage - developed by JJTRIALS research cooperative.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Sample: County Probation Staff
Inclusion Criteria:
All probation agency leadership and officers employed by the partnering sites who are (a) at least 18 years of age and (b) conversant in English in participating study counties are eligible
Exclusion Criteria:
There are no exclusionary criteria and no special classes of participants.
Sample: County Treatment Staff
Inclusion Criteria:
All treatment staff (agency directors, supervisors and clinical line staff) employed by participating treatment agencies who are at least 18 years of age and conversant in English in participating study counties will be asked to participate
Exclusion Criteria:
There are no exclusionary criteria and no special classes of participants.
Sample: Local Facilitators
Inclusion Criteria:
All county/local Justice Diversion Alternatives Initiative (JDAI) representatives that work with partnering sites who (a) are at least 18 years of age and (b) conversant in English in participating study counties are eligible
Exclusion Criteria:
There are no exclusionary criteria and no special classes of participants.
Sample: Probation Youth
Inclusion Criteria:
All youth who are on probation who are (a) 10-18 years of age and (b) conversant in English in participating study counties are eligible;
Exclusion Criteria:
There are no exclusionary criteria and no special classes of participants.
Facility Information:
Facility Name
Columbia University and New York State Psychiatric Instititute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Scaling up e-Connect in Juvenile Probation Settings
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