An interventional study of e-Connect in Suicide, sponsored by New York State Psychiatric Institute. Recruiting at 1 site in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Prevention
Among 386 studies in Suicide with a site in United States — 99 open to participants now, 113 under way, 2 of them phase 3. Suicide · United States.
Among the 386 studies in Suicide with a site in United States, this one is the 18th largest by planned enrollment of the 348 interventional ones, is one of 31 that started in 2023, is one of 288 with no phase, reaches primary completion later than 74 of the 112 other live ones, and was the 264th registered.
607 studies on the registry are indexed under Suicide; 162 are open to participants now.
This study's planned enrollment of 3,629 is above the median of 104 across 490 interventional studies indexed under Suicide.
Browse Suicide studies →99 of the 386 studies in Suicide with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 114 Suicide studies recruiting now, 54 (47%) set no upper age limit and 57 (50%) stop at 75 or younger; 52 take children under 18; 24 take healthy volunteers.
This study: 10 Years and older · all sexes · no healthy volunteers.
The full table on the hub →386 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 31 started in 2023.
Median enrollment 91 across the 348 interventional studies, 172 across the 36 observational. Of the 251 that completed or were terminated, 103 (41%) have results posted.
15 of 386 have an industry lead sponsor. The 10 most frequent:
New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
New York State Psychiatric Institute has 9 studies filed under Suicide — fewer than ten, so there is no comparison to draw.
43 of the studies in Suicide with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05696691Phase 3The University of Texas Health Science Center at San AntonioKetamine & Crisis Response Plan for Suicidal Ideation in the ED | 2026-12-31 |
| NCT05558332University of California, IrvineYouth Nominated Support Team | 2026-11 |
| NCT06470867VA Office of Research and DevelopmentRandomized Controlled Effectiveness Trial of VA S.A.V.E. | 2026-11-27 |
| NCT05897164Evidence-Based Practice Institute, Seattle, WAMobile Technology to Reduce Teen Substance Misuse | 2026-11-30 |
| NCT06460220Jennifer HughesSAFETY-Parent: Online Learning Module to Support Parents of Suicidal Youth | 2026-12 |
Among the 386 studies in Suicide with a site in United States, from their registry updates:
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.
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 promotes SB/BH service need identification, cross-system referral and youth SB/BH service use as compared with standard probation practice (baseline), for all youth on probation, regardless of youth clinical need or demographic characteristics, which would replicate previous 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 promotes SB/BH service need identification, cross-system referral and youth SB/BH service use as compared with standard probation practice (baseline), for all youth on probation, regardless of youth clinical need or demographic characteristics, which would replicate previous 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.
Sample: County Probation Staff
Inclusion Criteria:
Exclusion Criteria:
Sample: County Treatment Staff
Inclusion Criteria:
Exclusion Criteria:
Sample: Local Facilitators
Inclusion Criteria:
Exclusion Criteria:
Sample: Probation Youth
Inclusion Criteria:
Exclusion Criteria:
County receives training and materials and subsequently begins the e-Connect intervention
Behavioral: e-Connect
Standard of care practice in counties prior to the implementation of e-Connect
Implementation of the e-Connect system
Treatment initiation
Date of first behavioral health appointment/contact; extracted from Indiana Probation management information system (MIS)
Time frame: 3 years
Treatment engagement
\# of weeks in treatment, via termination date; extracted from MIS, Medicaid data
Time frame: 3 years
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
Time frame: 3 years
Cross-system Referral
Indicated by Referral Date; extracted from MIS
Time frame: 3 years
Uptake Adoption of e-Connect system
Acceptability, uptake and sustainability of e-Connect (BH and JJ staff; External and Local facilitators
Time frame: 6 months
Uptake Adoption - MIS
Number of eligible youth screened via e-Connect
Time frame: 3 years
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)
Time frame: 3 years
Fidelity of Facilitation
Checklists (self and observer) documenting completeness of activities; External/Local Facilitation activity tracker
Time frame: 3 years
Acceptability of e-Connect by the family
PO completes family debriefing checklist: family receptivity to screening results and referral plan
Time frame: 3 years
Sustainability of e-Connect protocol
Measured using MIS
Time frame: 1 year, 4 months
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
Time frame: 1 year, 4 months
Suicidal Behavior, Non-Suicidal Self-Injury (NSSI), BH knowledge
Measured during pre-post quizzes following web-based training modules; developed for study
Time frame: 3 years
Perceived importance of screening and referral to BH - Exploration Phase services
Subscales for screening - Measure assessing perceived importance of activities associated with screening, referral and linkage - developed by JJTRIALS research cooperative.
Time frame: 2 months
Plan to share: No
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Apr 2028, 59 months after the start.
Of 308 non-industry interventional studies with no phase under Suicide, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's planned 59 months is above that.
Counting every sponsor, half of 319 studies reached it within 30 months; a quarter within 15 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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