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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03586895
Other study ID # 7588
Secondary ID R01MH113599
Status Suspended
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date March 2025

Study information

Verified date August 2023
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators propose to create e-Connect, a new service delivery model that will enable real time identification and targeted, county-specific referral and linkage of participants with suicidal behavior (SB) and related behavioral health (BH) problems. e-Connect will: (i) establish and formalize interagency referral decisions based on clinical need, jointly derived by JJ (juvenile justice) and BH agencies; (ii) train probation staff to increase BH/SB understanding; (iii) utilize an existing evidence-based (EB) BH/SB screen; and (iv) develop a mobile application to seamlessly integrate screening, classification of clinical need and development of a related referral plan. There are 4 project phases: Development, Baseline, Implementation, and Sustainment/Evaluation. After development, activities take place in 10 NY (New York) counties and all study counties will begin the intervention at the same time. The investigators will examine changes in outcomes (e.g., service use) relative to baseline in (i) identification of participants service need (SB and BH correlates) in juvenile probationers; (ii) cross-system (probation-BH agency) referral; and (iii) participants BH service use (access and engagement). Analyses will further consider contributions of multi-level factors (e.g., staff, organizational, family, and community) that influence implementation (feasibility, acceptability, sustainability) of e-Connect across various probation department processing categories (e.g. status offenders, diversion cases). The investigators will consider the role of mediating elements (e.g., probation practices) in explaining the association between e-Connect and identification, referral, and service use.


Description:

While youth at all juvenile justice (JJ) processing points are at increased risk for suicidal behavior (SB) and associated behavioral health (BH) issues, those supervised in community settings (e.g., probation), may be at greatest risk: (a) protocols for identification and service referral are far more common in secure settings, (b) national policy increasingly favors community supervision/diversion over incarceration, (c) participants supervised in the community have far more access to means and opportunity than do those in secure settings, and (d) the multi- system coordination challenges to accessing BH care for community JJ participants are far greater than for those secure care. The investigators propose to adapt and test the utility of a multi-level service delivery model that increases identification of SB and related BH problems, guides targeted referral, trains staff and structures interagency collaboration to increase uptake of BH services by participants on probation; and document the organizational elements required to widely-implement this model in juvenile probation and community treatment settings. The model is based on our earlier, evidence-based linkage protocols from Project Connect, and capitalizes on technological advances unavailable at Connect's 2007 development, so as to address earlier implementation issues. Working in 10 NYS counties, project specific aims are (1) to develop technologically advanced cross-system identification/linkage service model that trains staff, formalizes interagency collaboration and referral decision-making and uses a mobile application to seamlessly combine (a) screening for SB and related BH problems, (b) classification of clinical need and (c) county-specific streamlined referral plans for BH services; (2) to examine the degree to which, compared to Baseline, e- Connect improves (a) intermediary PO practice outcomes (service need identification, cross-system referral) and increasing (b) participants BH service use (access, engagement); and (3) to elucidate multi-level factors (e.g., staff, organizational, participants/family, community,) that influence implementation (feasibility, acceptability, sustainability) of e-Connect across various probation department processing categories (e.g. status offenders, diversion cases) to inform comprehensive scale-up. The theoretically based mechanisms (e.g., changes in staff knowledge and self-efficacy; agency structural characteristics) by which PO practice change affects BH service use will also be examined. Guided by the GPM and CFIR framework, this 5-year study will comprise 4 project phases: (1) Development, (2) Baseline data collection, (3) Implementation, and (4) Sustainment. After development, it was originally planned that counties would be randomized to one of 4 Waves to begin implementation of e-Connect at 4-month intervals in a stepped-wedge design. Implementation activities continue for 18m and sites' use of e-Connect protocols after 18m will be an indication of sustainability. However, at the beginning of the trial, the state in which the current study was implemented introduced the raise the age policy requiring all adjusted youths on probation to receive an evidence-based BH screen. Thus, in order to be compliant with state mandates, all study counties had to begin the intervention at the same time, requiring a 'flattening' of the step-wedge design into a simple pre-post design. Due to this change, analyses were simplified as described in the statistical analysis section. This initiative is one of the first to address SB and advance JJ participants enrollment in BH treatment. Because the investigators propose addressing risk and acute SB, this study has the likelihood of identifying and linking to services high-risk, high need participants that are often overlooked.


Recruitment information / eligibility

Status Suspended
Enrollment 12838
Est. completion date March 2025
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years and older
Eligibility Sample: County Probation Leadership (Executive and Supervisory) and Line (Juvenile Probation Officers) Staff Inclusion Criteria: Probation Officers ages 21-70 years old with active employment at the probation department working with youth, or supervise those working with youth in one of the following capacities: probation supervision, assessment, and referral, or engage in work that is related to policies, procedures, and decisions around these activities in 10 site counties Exclusion Criteria: There are no exclusionary criteria and no special classes of participants. Sample: Youth on Probation Inclusion Criteria: All new intakes ages 10-18 years old Exclusion Criteria: There are no exclusionary criteria and no special classes of participants.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
e-Connect
e-Connect

Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (4)

Lead Sponsor Collaborator
Columbia University Chestnut Health Systems, George Mason University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Suicidal Behavior, Non-Suicidal Self-Injury (NSSI), BH knowledge Measured during pre-post quizzes following web-based training modules; developed for study Years 1-5
Other Perceived importance of screening and referral to BH - Baseline Phase services Subscales for screening - Measure assessing perceived importance of activities associated with screening, referral and linkage - developed by JJTRIALS research cooperative. 2 months
Primary Behavioral health treatment initiation Date of first behavioral health appointment/contact extracted from state management information system (MIS) Monthly in years 2- 5
Secondary Behavioral health referral Clinically appropriate referral made by probation officer to behavioral health provider, based on screening results, indicated by referral date extracted from MIS Day one of probation
Secondary Youth screened for risk of suicide Evidence-based screening tool self administered by youth Day one of probation
Secondary Family Experience and Fidelity of e-Connect PO completes family debriefing checklist: family receptivity to screening results and referral plan Bimonthly years 2-5
Secondary e-Connect Sustainability Ongoing use of e-Connect during post implementation phase end of implementation through sustainment period, monthly
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