iKinnect2.0 App for Suicide Risk in Youth

No longer recruiting at 1 trial location

Overseen By Allison Ruork, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Evidence-Based Practice Institute, Seattle, WA

Disqualifiers: Non-English speakers, No smartphone, others

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an app called iKinnect2.0 to help reduce suicide risk in young people involved with the juvenile justice system. The study compares iKinnect2.0 with a control app, Life360, to determine which provides more effective support to youth and their caregivers. The trial targets youth aged 15-21 who have been arrested and are at significant risk for suicide, along with their primary caregivers. The goal is to assess whether the app can improve coping strategies and parent-youth relationships, ultimately reducing the risk of suicide. Participants will use the app regularly over a 16-week period. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could significantly impact the well-being of at-risk youth.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the iKinnect2.0 app is safe for youth?

Research shows that iKinnect2.0 aims to reduce risky behaviors in young people, including those related to suicide and self-harm. Although specific safety data on the iKinnect2.0 app is not available, the app serves as a tool to prevent harmful actions by providing support and resources to improve mental health.

The study is labeled as "Not Applicable" in terms of phase, indicating it is not a traditional drug or medical device trial. Instead, it examines the app's usage and its impact on behavior. Generally, mental health support apps are considered safe, as they do not involve invasive procedures or medications.

In summary, while specific safety data for iKinnect2.0 is lacking, the app aims to create a safe and supportive environment to help young people manage suicidal thoughts and behaviors. Prospective participants should know that the app's primary purpose is to offer mental health resources and support, which are generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iKinnect2.0 app because it offers a novel approach to managing suicide risk in youth through digital intervention. Unlike traditional therapies that often require in-person sessions with mental health professionals, iKinnect2.0 provides a convenient, accessible option that can be used anytime via a mobile app. This app is designed to engage users multiple times a day, potentially increasing its effectiveness by integrating support into daily life. By leveraging technology, iKinnect2.0 aims to provide timely resources and support, which could significantly enhance existing treatment methods for young people at risk.

What evidence suggests that the iKinnect2.0 app is effective for reducing suicide risk in youth?

Research has shown that iKinnect2.0, an app tested in this trial, might help reduce suicidal thoughts and behaviors in young people within the juvenile justice system. Studies have found that users of iKinnect2.0 report fewer issues with self-harm and behavior. Additionally, parents of these young people often feel more confident in preventing suicide and managing parenting challenges. The app includes tools to help young people manage stress and improve mental health. These early results suggest it could effectively prevent suicide. ^{1 2 3 5 6}

Who Is on the Research Team?

Cindy Schaeffer, PhD

Principal Investigator

University of Maryland

Linda A. Dimeff, PhD

Principal Investigator

Evidence-Based Practice Institute

Are You a Good Fit for This Trial?

This trial is for English-speaking youth aged 15-21 at high risk of suicide, with a history of self-harm or attempts, who use a smartphone with data and live with their primary caregiver. Caregivers must also participate, be fluent in English, and have a smartphone. Youth should be involved in juvenile justice services.

Inclusion Criteria

I live with my parent or guardian almost every day of the week.

I am a young person at risk of suicide and willing to talk about it with my parent.

PARENT/GUARDIAN: Fluent in English

Exclusion Criteria

To ensure consistency of planned and actual enrollment, particularly of Black youth, researchers will begin to exclude youth of certain races once pre-established recruitment milestones for a specific racial group is achieved.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Testing

Usability and acceptability testing of iKinnect2.0 features with target end-users and stakeholders

8 weeks

Randomized Controlled Trial

Participants are randomly assigned to iKinnect2.0 or Life360 control app for a 16-week trial to test the efficacy of iKinnect2.0 in reducing suicidal behaviors and improving coping strategies

16 weeks

Assessments at baseline, 4, 8, and 16 weeks

Follow-up

Participants are monitored for safety and effectiveness after the trial

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active Control App
• iKinnect2.0

Trial Overview

The study compares iKinnect2.0, an app designed to help prevent suicide among young people involved in the juvenile justice system, against Life360 (a control app) plus electronic resources on suicide prevention over a period of 16 weeks.

How Is the Trial Designed?

Group I: iKinnect2.0 Experimental Treatment 1 Intervention

Parent-Youth dyads assigned to the iKinnect2.0 condition will be given access to the iKinnect2.0 app that has been developed for this study. Parent and youth will be asked to download the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial. The app is designed to be used several times throughout each day.

Group II: Attention-Control Placebo App & Supporting Materials Placebo Group 1 Intervention

Parent-Youth dyads assigned to the control condition will be asked to download the free Life360 app to their phone during the baseline assessment process and will also be given access to an online suicide resources brochure. Participants will be asked to use the control-condition app and associated materials as often as they would like throughout the duration of the 16 week trial.

Who Is Running the Clinical Trial?

Evidence-Based Practice Institute, Seattle, WA

Lead Sponsor

Trials

9

Recruited

29,800+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of Maryland

Collaborator

Trials

171

Recruited

325,000+

Published Research Related to This Trial

In a study of 32 adolescent psychiatric inpatients, researchers used daily diaries to track risk factors for suicidal ideation, demonstrating that combining multiple risk factors significantly improved the prediction of suicidal crises, with accuracy rates reaching an area under the ROC curve (AUC) of 0.80-0.91.

The findings suggest that mobile technology can effectively identify early signs of suicide-related crises, which could enhance clinical decision-making and intervention strategies for at-risk youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Intensive Longitudinal Data to Identify Early Predictors of Suicide-Related Outcomes in High-Risk Adolescents: Practical and Conceptual Considerations. Czyz, EK., Yap, JRT., King, CA., et al.[2022]

The LifeBuoy app, designed based on dialectical behavior therapy (DBT), is being tested in a randomized controlled trial with 378 young adults aged 18 to 25 to evaluate its effectiveness in reducing suicidal thoughts and improving mental well-being.

This study is significant as it is the first to assess a DBT-informed smartphone app for suicide prevention in young adults, incorporating safety measures like clinical psychologist support for participants at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Health Intervention (LifeBuoy App) to Help Young People Manage Suicidal Thoughts: Protocol for a Mixed-Methods Randomized Controlled Trial. Han, J., McGillivray, L., Wong, QJ., et al.[2020]

A pilot study involving 60 students across eight schools demonstrated that machine learning models can effectively identify suicide risk based on language samples collected during therapy sessions, with models achieving good accuracy (AUC up to 0.78).

The integration of voice collection technology into therapists' workflows shows promise for enhancing risk identification in adolescents, potentially leading to earlier interventions for those at risk of suicide or self-harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility Study Using a Machine Learning Suicide Risk Prediction Model Based on Open-Ended Interview Language in Adolescent Therapy Sessions. Cohen, J., Wright-Berryman, J., Rohlfs, L., et al.[2022]

The STOP-SAS is a reliable and valid web-based questionnaire designed to assess suicide risk in children and adolescents, developed through extensive collaboration and testing with 395 adolescents, 110 children, 637 parents, and 716 clinicians.

The questionnaire demonstrated excellent internal consistency across all user groups and strong correlations with the established Columbia Suicide Severity Rating Scale (C-SSRS), indicating its effectiveness in identifying suicidality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and psychometric properties of the Suicidality: Treatment Occurring in Paediatrics (STOP) Suicidality Assessment Scale (STOP-SAS) in children and adolescents. Flamarique, I., Santosh, P., Zuddas, A., et al.[2022]

Real-time monitoring technology offers promising opportunities to study suicidal thoughts and behaviors in youth, but researchers must be cautious and fully understand the limitations of these methods before widespread adoption.

The article outlines future directions for research, including new questions and analytical methods, while also addressing potential technical, logistical, and ethical challenges that may arise in implementing real-time monitoring for at-risk youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time Monitoring of Suicide Risk among Adolescents: Potential Barriers, Possible Solutions, and Future Directions. Kleiman, EM., Glenn, CR., Liu, RT.[2023]

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]

Machine learning methods, including decision trees and random forests, did not improve the classification of suicide attempt history among youth in medical settings, indicating that the relationships may be primarily linear rather than complex.

Key factors associated with suicide attempts included a history of suicide planning, active and passive suicidal ideation, and nonsuicidal self-injury, highlighting the need for focused suicide risk screenings in pediatric healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using machine learning to classify suicide attempt history among youth in medical care settings. Burke, TA., Jacobucci, R., Ammerman, BA., et al.[2021]

The study evaluated the feasibility of two mental health apps, BackUp and mEMA, for treating depressed outpatients with suicidal ideation, involving 17 participants over a 3-month period.

Both apps were found to be usable and acceptable, scoring above the thresholds for usability and satisfaction, but the study did not meet the criteria for sufficient uptake, indicating that further exploration is needed for integrating these apps into routine mental healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of using smartphone apps as treatment components for depressed suicidal outpatients. Nuij, C., van Ballegooijen, W., de Beurs, D., et al.[2023]

The pilot phase of the SmartCrisis 2.0 trial demonstrated that a smartphone-based safety plan for patients with recent suicidal behavior is feasible and well-accepted, with a participation rate of 77% and high satisfaction ratings (overall satisfaction score of 9.6 out of 10).

Patients found the safety plan useful (7.4/10) and easy to use (8.9/10), with common coping strategies including walking and exercise, indicating that the app could be a valuable tool in clinical practice for supporting mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based safety plan for suicidal crisis: The SmartCrisis 2.0 pilot study. Porras-Segovia, A., De Granda-Beltrán, AM., Gallardo, C., et al.[2023]

The mobile app developed as part of the SERO suicide prevention program aims to reduce suicides and suicide attempts by enhancing self-management for individuals at risk, incorporating strategies like safety planning and mood tracking.

The app's design was informed by collaboration among health professionals, individuals at risk, and their families, ensuring it addresses real needs and integrates essential suicide prevention strategies effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SERO - A New Mobile App for Suicide Prevention. Meier, L., Gurtner, C., Nuessli, S., et al.[2022]

Citations

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clinicaltrials.gov/study/NCT04909203?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Evidence-Based%20Practice%20Institute,%20Seattle,%20WA%22)&viewType=Table&rank=2

iKinnect2.0 for Juvenile Justice Involved Youth at Risk ...

0 participants will report a significantly greater decrease in youths' suicidal, NSSI, and conduct-problem behaviors, and less recidivism. Furthermore, ...

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clinicaltrial.be/en/details/19814?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

iKinnect2.0 for Juvenile Justice Involved Youth at Risk f...

iKinnect parents will report greater increases in parenting and suicide prevention efficacy. iKinnect youth will report greater decreases in ...

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withpower.com/trial/phase-self-injurious-behavior-2022-80257

iKinnect2.0 App for Suicide Risk in Youth

Trial Overview The study compares iKinnect2.0, an app designed to help prevent suicide among young people involved in the juvenile justice system, against ...

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aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04909203?keyword=%22Self-Harm%22

iKinnect2.0 for Juvenile Justice Involved Youth at Risk ...

iKinnect parents will report greater increases in parenting and suicide prevention efficacy.~2. iKinnect youth will report greater decreases in suicidal, NSSI, ...

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ikinnectapp.com/about

About

iKinnect2.0 extends the original technology by building in powerful suicide prevention tools to reduce teen suicide. In addition to its original features ...

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aging.networkofcare.org

aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04909203?keyword=%22Suicidality%22

iKinnect2.0 for Juvenile Justice Involved Youth at Risk ...

This project seeks to significantly expand iKinnect to prevent NSSI, suicidal behaviors (ideation, planning, attempts), and death by suicide in JJ-involved ...