- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05541926
Scaling up e-Connect in Juvenile Probation Settings
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 Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Katherine S Elkington, Ph.D.
- Phone Number: 646-774-6965
- Email: ke2143@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University and New York State Psychiatric Instititute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: e-Connect
County receives training and materials and subsequently begins the e-Connect intervention
|
Implementation of the e-Connect system
|
No Intervention: Standard of Care
Standard of care practice in counties prior to the implementation of e-Connect
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment initiation
Time Frame: 3 years
|
Date of first behavioral health appointment/contact; extracted from Indiana Probation management information system (MIS)
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment engagement
Time Frame: 3 years
|
# of weeks in treatment, via termination date; extracted from MIS, Medicaid data
|
3 years
|
Screen/Identify Youth Service Need
Time Frame: 3 years
|
Via e-Connect system and recorded in Caseload Explorer: YASI Orbis, Chestnut Information indicates whether screening has occurred; Extracted from MIS
|
3 years
|
Cross-system Referral
Time Frame: 3 years
|
Indicated by Referral Date; extracted from MIS
|
3 years
|
Uptake Adoption of e-Connect system
Time Frame: 6 months
|
Acceptability, uptake and sustainability of e-Connect (BH and JJ staff; External and Local facilitators
|
6 months
|
Uptake Adoption - MIS
Time Frame: 3 years
|
Number of eligible youth screened via e-Connect
|
3 years
|
Fidelity to use of e-Connect system
Time Frame: 3 years
|
Measured by Stages of Implementation Completion (SIC) tool.
indicated by implementation stages complete; time to stage completion; activities completed w/in each stage)
|
3 years
|
Fidelity of Facilitation
Time Frame: 3 years
|
Checklists (self and observer) documenting completeness of activities; External/Local Facilitation activity tracker
|
3 years
|
Acceptability of e-Connect by the family
Time Frame: 3 years
|
PO completes family debriefing checklist: family receptivity to screening results and referral plan
|
3 years
|
Sustainability of e-Connect protocol
Time Frame: 1 year, 4 months
|
Measured using MIS
|
1 year, 4 months
|
Sustainability achieved in implementation process
Time Frame: 1 year, 4 months
|
Stages of Implementation Completion (SIC) tool measures - Implementation stages complete; time to stage completion; activities completed within each stage measured by the SIC tool
|
1 year, 4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suicidal Behavior, Non-Suicidal Self-Injury (NSSI), BH knowledge
Time Frame: 3 years
|
Measured during pre-post quizzes following web-based training modules; developed for study
|
3 years
|
Perceived importance of screening and referral to BH - Exploration Phase services
Time Frame: 2 months
|
Subscales for screening - Measure assessing perceived importance of activities associated with screening, referral and linkage - developed by JJTRIALS research cooperative.
|
2 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8359
- R01MH130845 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicide
-
Syeda AYAT E ZAINAB AliUniversity of Leicester; University of WuerzburgRecruitingSuicide, Attempted | Suicide | Suicide Prevention | Completed SuicidePakistan
-
Seattle Children's HospitalNationwide Children's HospitalRecruitingSuicidal Ideation | Suicide Threat | Suicide and Self-harm | Suicide AttemptsUnited States
-
Vestre Viken Hospital TrustSouth-Eastern Norway Regional Health AuthorityRecruitingEcological Momentary Assessment | Suicide Risk | Suicide Attempt | Suicide Ideation | Suicide PreventionNorway
-
VA Office of Research and DevelopmentNot yet recruitingSuicidal Ideation | Suicide Attempt | Suicide PreventionUnited States
-
Franciscan Hospital For Children, INC.National Institute of Mental Health (NIMH); Harvard UniversityRecruitingSuicidal Ideation | Self-Injurious Behavior | Suicide AttemptsUnited States
-
Mental Health Services in the Capital Region, DenmarkCompletedSuicide Prevention | Suicidal Thoughts | Suicide AttemptsDenmark
-
University Hospital, MontpellierINSERM U960 - Cognitive Neuroscience Laboratory - Paris, FranceTerminatedDepression | History of Suicide AttemptFrance
-
Boston UniversityUnited States Department of Defense; The University of Texas Health Science... and other collaboratorsNot yet recruiting
-
Kaiser PermanenteNational Institute of Mental Health (NIMH); Henry Ford Health System; HealthPartners...Enrolling by invitationSuicide, Attempted | Suicide, FatalUnited States
Clinical Trials on e-Connect
-
Columbia UniversityNational Institute of Mental Health (NIMH); Chestnut Health Systems; George Mason...SuspendedSuicideUnited States
-
Columbia UniversityNational Institute of Mental Health (NIMH)Completed
-
Minnesota Department of HealthCompleted
-
University of South CarolinaNational Institute of Nursing Research (NINR)RecruitingConnect Through PLAY: A Staff-based Physical Activity Intervention for Middle School Youth (Connect)Physical Activity | Obesity PreventionUnited States
-
Northwestern UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedDropout | Attendance and Truancy | Student EngagementUnited States
-
George Washington UniversityBill and Melinda Gates Foundation; Save the Children; Save the Children International...Active, not recruitingContraceptive UsageTanzania
-
RANDNational Institute of Mental Health (NIMH); University of Stellenbosch; Western...Enrolling by invitation
-
University of PittsburghNational Cancer Institute (NCI)CompletedAdvanced CancerUnited States
-
University of RochesterNational Institutes of Health (NIH); National Center for Advancing Translational...TerminatedSuicide, AttemptedUnited States
-
University of RochesterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedFetal Alcohol Spectrum DisordersUnited States