NCT05541926

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,629

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
May 2023Aug 2027

First Submitted

Initial submission to the registry

September 9, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

May 2, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

4 years

First QC Date

September 9, 2022

Last Update Submit

June 23, 2025

Conditions

Suicide

Outcome Measures

Primary Outcomes (1)

  • Treatment initiation

    Date of first behavioral health appointment/contact; extracted from Indiana Probation management information system (MIS)

    3 years

Secondary Outcomes (10)

  • Treatment engagement

    3 years

  • Screen/Identify Youth Service Need

    3 years

  • Cross-system Referral

    3 years

  • Uptake Adoption of e-Connect system

    6 months

  • Uptake Adoption - MIS

    3 years

  • +5 more secondary outcomes

Other Outcomes (2)

  • Suicidal Behavior, Non-Suicidal Self-Injury (NSSI), BH knowledge

    3 years

  • Perceived importance of screening and referral to BH - Exploration Phase services

    2 months

Study Arms (2)

e-Connect

EXPERIMENTAL

County receives training and materials and subsequently begins the e-Connect intervention

Behavioral: e-Connect

Standard of Care

NO INTERVENTION

Standard of care practice in counties prior to the implementation of e-Connect

Interventions

e-ConnectBEHAVIORAL

Implementation of the e-Connect system

e-Connect

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Sample: County Treatment Staff
  • 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
  • Sample: Local Facilitators
  • 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
  • Sample: Probation Youth
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University and New York State Psychiatric Instititute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Stepped-wedge design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 15, 2022

Study Start

May 2, 2023

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)