iKinnect2.0 App for Suicide Risk in Youth
Recruiting in Palo Alto (17 mi)
+1 other location
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Evidence-Based Practice Institute, Seattle, WA
Disqualifiers: Non-English speakers, No smartphone, others
Trial Summary
What is the purpose of this trial?This study is a 16-week intent-to-treat randomized controlled trial (RCT) with 120 suicidal juvenile justice (JJ)-involved transition-age (TA) youth (age 15-21 years) and a primary caregiver (dyads). Dyads will be randomly assigned to iKinnect2.0 (n=60 dyads) or Life360 (control app) plus an electronic suicide resources brochure (n=60 dyads). This design will test iKinnect2.0's new features for suicide prevention against TA youth awareness of and access to high-quality suicide prevention resources, while simultaneously testing features relating to conduct problems and parent management against parents knowing the TA youth's whereabouts in real-time and controlling for dyad member engagement in technology (Life360). Participants will be assessed at baseline, 4, 8 and 16 weeks. Primary youth-reported outcomes relating to suicide risk include: Suicidal behaviors (ideation, planning, attempts), non-suicidal self-injurious behaviors, self-efficacy in coping with distress, and use of imminent distress coping strategies (behavioral skills, use of crisis stabilization plan). Youth will also report on their criminal behavior. Primary caregiver-reported outcome variables relating to youth suicide include: Self-efficacy in applying family-based suicide-prevention strategies and reported use of those strategies; caregivers will also report on their own functioning (efficacy/confidence in parenting skills, life stress), TA youth functioning (internalizing and externalizing symptoms), parental management behaviors (expectation clarity, parental monitoring, discipline effectiveness/consistency, use of rewards), and parent-youth relationship quality (communication, conflict, support). App satisfaction and use of technology outcomes (i.e., degree of app usage, features used) will be examined and reported descriptively.
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 data supports the effectiveness of the iKinnect2.0 treatment for suicide risk in youth?
Research shows that smartphone apps for mental health, like safety planning and self-monitoring apps, are considered usable and acceptable by patients with suicidal thoughts. These apps can help manage suicidal ideation by providing support and strategies, suggesting that similar apps like iKinnect2.0 could be effective in helping youth at risk.
12345How is the iKinnect2.0 treatment different from other treatments for suicide risk in youth?
The iKinnect2.0 treatment is unique because it uses a mobile app to monitor and assess suicide risk in real-time, allowing for immediate intervention and support, unlike traditional methods that rely on periodic assessments.
678910Eligibility Criteria
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.
I am a parent or guardian aged 18 or older.
+7 more
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.
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: iKinnect2.0Experimental Treatment1 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 MaterialsPlacebo Group1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Maryland, BaltimoreBaltimore, MD
Evidence-Based Practice InstituteSeattle, WA
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Who Is Running the Clinical Trial?
Evidence-Based Practice Institute, Seattle, WALead Sponsor
National Institute of Mental Health (NIMH)Collaborator
University of MarylandCollaborator
References
The feasibility of using smartphone apps as treatment components for depressed suicidal outpatients. [2023]Mental health smartphone apps could increase the safety and self-management of patients at risk of suicide, but it is still unclear whether it is feasible to integrate such apps into routine mental healthcare. This study reports on the feasibility of using a safety planning app (BackUp) and a self-monitoring app (mEMA) as components of the routine treatment of depressed outpatients with suicidal ideation. Clinicians were trained in working with both of the apps, and they invited their eligible patients with suicidal ideation for study participation. Patients used the apps for 3 months and discussed these with their clinician during treatment. Patients completed assessments at baseline (T0), 4 weeks (T1) and post-test (T2, 12 weeks after baseline). Both patients and clinicians also participated in telephone interviews. Feasibility was assessed in terms of usability (score > 70 on System Usability Scale, SUS), acceptability (score > 20 on Client Satisfaction Questionnaire-8, CSQ-8), and uptake (sufficient rates of component completion and app usage in treatment). The sample included 17 adult outpatients (52.9% male, age range 20-50 years) diagnosed with a depressive disorder and suicidal ideation at baseline. BackUp was rated by patients at above the cut-off scores for usability (SUS mean score at T1 75.63 and at T2 77.71) and acceptability (CSQ-8 mean score at T1 23.42 and at T2 23.50). mEMA was similarly rated (SUS mean score at T1 75.83 and at T2 76.25; CSQ-8 mean score at T1 23.92 and at T2 22.75). Telephone interviews with patients and clinicians confirmed the usability and acceptability. The uptake criteria were not met. Our findings suggest that mobile safety planning and mobile self-monitoring can be considered acceptable and usable as treatment components for depressed suicidal outpatients, but the integration of apps into routine treatment needs to be further explored.
Smartphone-based safety plan for suicidal crisis: The SmartCrisis 2.0 pilot study. [2023]Here we present the findings of the pilot phase of the SmartCrisis 2.0 Randomized Clinical Trial. This pilot study aimed to explore the feasibility and acceptability of a safety plan contained in a smartphone app. Our sample consisted patients with a history of recent suicidal behaviour who installed a smartphone-based safety plan. To explore the satisfaction with of the safety plan, two patient satisfaction surveys were conducted: one qualitative and one quantitative. To explore the objective use of the safety plan, we gained access to texts contained in the safety plans completed by the patients. Participation rate was 77%, while 48.9% patients completed both satisfaction surveys at the end of the pilot phase. N = 105 successfully installed the safety plan. In a scale from 1 to 10, users rated the usefulness of the security plan at 7.4, the usability at 8.9, the degree to which they would recommend it to others at 8.6 and the overall satisfaction with the project including evaluations at 9.6. The most widely completed tab was warning signs. Feeling sad or lonely was the warning sign most commonly reported by patients. The second most completed tab was internal coping strategies. Walking or practicing any other exercise was the strategy most commonly resorted to. Our smartphone-based safety plan appears to be a feasible intervention. Data obtained from this pilot study showed high participation rates and high acceptability by patients. This, together with the general satisfaction with the project, supports its implementation in the clinical practice.
SERO - A New Mobile App for Suicide Prevention. [2022]Mobile apps indicate a positive effect on suicidal ideation and potential impact on suicide attempts. As part of the SERO suicide prevention program, Lucerne Psychiatry in collaboration with partner organizations aims to reduce suicides and suicide attempts in its service area, and to improve the self-management of suicidal individuals with a mobile app. The concept for such an app was developed in a trialog with health professionals, persons at risk and their relatives and its functions were compared to six known essential app-based strategies for suicide prevention, such as the development of a safety plan, access to support networks and tracking of mood. We present the concept and architecture for the app and discuss potential added value, which may result from the intertwining of the strategies within the app, which will be available in its first version in late 2022.
A Mobile Health Intervention (LifeBuoy App) to Help Young People Manage Suicidal Thoughts: Protocol for a Mixed-Methods Randomized Controlled Trial. [2020]Self-help smartphone apps offer a new opportunity to address youth suicide prevention by improving access to support and by providing potentially high fidelity and cost-effective treatment. However, there have been very few smartphone apps providing evidence-based support for suicide prevention in this population. To address this gap, we developed the LifeBuoy app, a self-help smartphone app informed by dialectical behavior therapy (DBT), to help young people manage suicidal thoughts in their daily life.
The feasibility of using smartphone apps to manage self-harm and suicidal acts in adolescents admitted to an inpatient mental health ward. [2022]Label="OBJECTIVE" NlmCategory="OBJECTIVE">The aim of this study is to assess the feasibility (uptake, retention and adherence) and acceptability of a combination of smartphone apps to deliver a digitized safety plan, BeyondNow, and personalized management strategies, BlueIce, with adolescents discharged from a mental health inpatient ward following self-harm, suicidal ideation and/or behavior.
A Feasibility Study Using a Machine Learning Suicide Risk Prediction Model Based on Open-Ended Interview Language in Adolescent Therapy Sessions. [2022]As adolescent suicide rates continue to rise, innovation in risk identification is warranted. Machine learning can identify suicidal individuals based on their language samples. This feasibility pilot was conducted to explore this technology's use in adolescent therapy sessions and assess machine learning model performance.
Development and psychometric properties of the Suicidality: Treatment Occurring in Paediatrics (STOP) Suicidality Assessment Scale (STOP-SAS) in children and adolescents. [2022]To create a self-reported, internet-based questionnaire for the assessment of suicide risk in children and adolescents.
Using Intensive Longitudinal Data to Identify Early Predictors of Suicide-Related Outcomes in High-Risk Adolescents: Practical and Conceptual Considerations. [2022]Mobile technology offers new possibilities for assessing suicidal ideation and behavior in real- or near-real-time. It remains unclear how intensive longitudinal data can be used to identify proximal risk and inform clinical decision making. In this study of adolescent psychiatric inpatients (N = 32, aged 13-17 years, 75% female), we illustrate the application of a three-step process to identify early signs of suicide-related crises using daily diaries. Using receiver operating characteristic (ROC) curve analyses, we considered the utility of 12 features-constructed using means and variances of daily ratings for six risk factors over the first 2 weeks postdischarge (observations = 360)-in identifying a suicidal crisis 2 weeks later. Models derived from single risk factors had modest predictive accuracy (area under the ROC curve [AUC] 0.46-0.80) while nearly all models derived from combinations of risk factors produced higher accuracy (AUCs 0.80-0.91). Based on this illustration, we discuss implications for clinical decision making and future research.
Using machine learning to classify suicide attempt history among youth in medical care settings. [2021]The current study aimed to classify recent and lifetime suicide attempt history among youth presenting to medical settings using machine learning (ML) as applied to a behavioral health screen self-report survey.
Real-Time Monitoring of Suicide Risk among Adolescents: Potential Barriers, Possible Solutions, and Future Directions. [2023]Recent advances in real-time monitoring technology make this an exciting time to study risk for suicidal thoughts and behaviors among youth. Although there is good reason to be excited about these methods, there is also reason for caution in adopting them without first understanding their limitations. In this article, we present several broad future directions for using real-time monitoring among youth at risk for suicide focused around three broad themes: novel research questions, novel analytic methods, and novel methodological approaches. We also highlight potential technical, logistical, and ethical challenges with these methodologies, as well as possible solutions to these challenges.