e-Connect for Suicide Prevention in Youth

Overseen By Katherine S Elkington, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: New York State Psychiatric Institute

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

3629 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is e-Connect for Suicide Prevention in Youth safe for humans?

The research highlights challenges in defining and reporting adverse events (unwanted side effects) in suicide prevention studies, making it hard to evaluate safety. However, using multiple methods like structured follow-up calls can improve detection of these events, suggesting that careful monitoring is important for safety in such interventions. ^{1 2 3 4 5}

How is the e-Connect treatment for suicide prevention in youth different from other treatments?

The e-Connect treatment is unique because it likely involves an online or telecommunication-based approach, which can include e-learning modules or online interventions to improve knowledge and self-confidence in recognizing and addressing suicidal behavior in youth. This method is distinct from traditional face-to-face therapy by providing accessible, flexible, and potentially anonymous support, which can be particularly appealing to young people who may be hesitant to seek in-person help. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment e-Connect for suicide prevention in youth?

Research shows that telecommunication-based interventions, like text messaging, can help reduce suicidal thoughts and behaviors in youths after hospital discharge. Additionally, using smartphone apps for safety planning and personalized management strategies has been found feasible and acceptable for managing self-harm and suicidal acts in adolescents. ^{8 11 12 13 14}

Are You a Good Fit for This Trial?

This trial is for probation agency leadership and officers at least 18 years old who speak English, working in the partnering sites of the study's Indiana counties. There are no specific exclusion criteria or special classes of participants.

Inclusion Criteria

I am a youth on probation, aged 10-18, and speak English.

Exclusion Criteria

There are no exclusionary criteria and no special classes of participants.

Timeline for a Trial Participant

Scale-Up Strategy Efforts

Focused on preparing for scale-up of the e-Connect program

1 year

e-Connect-scaleup Implementation

Implementation of e-Connect in juvenile probation settings, including Exploration and Preparation, and Implementation and Sustainment

2 years

Scale-Up Effectiveness Trial/Outcome Evaluation

Evaluation of the effectiveness of the e-Connect scale-up, including clinical and cost-effectiveness assessments

1 year

Follow-up

Participants are monitored for the sustainability and fidelity of the e-Connect implementation

1 year, 4 months

What Are the Treatments Tested in This Trial?

Interventions

• e-Connect

Trial Overview The trial is testing e-Connect, a program designed to identify suicide risk and behaviors among justice-involved youth and link them across systems. It involves preparing for scale-up, implementing e-Connect in new settings, and evaluating its effectiveness over three phases.

How Is the Trial Designed?

Group I: e-Connect Experimental Treatment 1 Intervention

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

Group II: Standard of Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

Indiana University School of Medicine

Collaborator

Trials

194

Recruited

181,000+

Chestnut Health Systems

Collaborator

Trials

27

Recruited

24,500+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

George Mason University

Collaborator

Trials

60

Recruited

50,200+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

In a study of 181 youth suicide attempters in emergency departments, key factors influencing the decision to admit or discharge included the specific ED site, the presence of a suicide plan, and parental reports of problems.

Hospitalization was linked to better connections to outpatient treatment and increased use of intensive services, highlighting the importance of inpatient care for improving outcomes in high-risk youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors and Outcomes of Psychiatric Hospitalization in Youth Presenting to the Emergency Department with Suicidality. Hughes, JL., Anderson, NL., Wiblin, JL., et al.[2022]

A pilot study of a text-messaging intervention for youths discharged from the hospital after suicidal thoughts showed it was feasible and well-received, helping to reduce suicidal thoughts and behaviors.

The positive results of this intervention led to the Maryland Department of Health expanding the program to offer similar support to all Maryland residents, highlighting its potential effectiveness in suicide prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Text-Messaging Intervention for Suicidal Youths After Emergency Department Discharge. Ryan, TC., Chambers, S., Gravey, M., et al.[2022]

The study involving 20 adolescents discharged from a mental health ward showed that the smartphone apps BeyondNow and BlueIce were feasible and acceptable, with most participants accessing them at least once during the six-week follow-up.

While many participants found the apps easy to use, a significant portion (47%) felt they would not ensure safety during a crisis; however, improvements in suicide resilience were noted, indicating potential benefits in managing self-harm and suicidal behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of using smartphone apps to manage self-harm and suicidal acts in adolescents admitted to an inpatient mental health ward. Muscara, F., Ng, O., Crossley, L., et al.[2022]

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

In the ED-SAFE study, structured telephone follow-up assessments were crucial for identifying adverse events (AEs), detecting 45% of total AEs that were missed by chart reviews alone.

The detection of suicide attempts varied significantly by method, with structured follow-ups identifying 59% of attempts compared to only 18% through chart reviews, highlighting the importance of using multiple detection methods in suicide research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using structured telephone follow-up assessments to improve suicide-related adverse event detection. Arias, SA., Zhang, Z., Hillerns, C., et al.[2021]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Predictors and Outcomes of Psychiatric Hospitalization in Youth Presenting to the Emergency Department with Suicidality. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Brief Text-Messaging Intervention for Suicidal Youths After Emergency Department Discharge. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The feasibility of using smartphone apps to manage self-harm and suicidal acts in adolescents admitted to an inpatient mental health ward. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The 18-month impact of an emergency room intervention for adolescent female suicide attempters. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Telecommunication and suicide prevention: hopes and challenges for the new century. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A systematic review of validated suicide outcome classification in observational studies. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Using structured telephone follow-up assessments to improve suicide-related adverse event detection. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. [2009]

10. United States pubmed.ncbi.nlm.nih.gov

Improving Shared Situation Awareness for High-risk Therapies in Hospitalized Children. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Online suicide risk screening and intervention with college students: a pilot randomized controlled trial. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Effectiveness of adolescent suicide prevention e-learning modules that aim to improve knowledge and self-confidence of gatekeepers: study protocol for a randomized controlled trial. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Electronic bridge to mental health for college students: A randomized controlled intervention trial. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Connect: an effective community-based youth suicide prevention program. [2022]