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.