Clinical trial NCT05541926: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suicide
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Indiana University School of Medicine
name: George Mason University
name: Chestnut Health Systems
name: National Institute of Mental Health (NIMH)
name: Columbia University
First posted: 2022-09-15
Enrollment: 3629
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge design
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Treatment initiation
timeFrame: 3 years
Secondary outcomes:
measure: Treatment engagement
timeFrame: 3 years
measure: Screen/Identify Youth Service Need
timeFrame: 3 years
measure: Cross-system Referral
timeFrame: 3 years
measure: Uptake Adoption of e-Connect system
timeFrame: 6 months
measure: Uptake Adoption - MIS
timeFrame: 3 years
measure: Fidelity to use of e-Connect system
timeFrame: 3 years
measure: Fidelity of Facilitation
timeFrame: 3 years
measure: Acceptability of e-Connect by the family
timeFrame: 3 years
measure: Sustainability of e-Connect protocol
timeFrame: 1 year, 4 months
measure: Sustainability achieved in implementation process
timeFrame: 1 year, 4 months
Other outcomes:
measure: Suicidal Behavior, Non-Suicidal Self-Injury (NSSI), BH knowledge
timeFrame: 3 years
measure: Perceived importance of screening and referral to BH - Exploration Phase services
timeFrame: 2 months
Locations:
city: New York
country: United States
facility: Columbia University and New York State Psychiatric Instititute
state: New York
Study officials:
References: