Digital Intervention for Suicide Prevention

Overseen By Brandie George-Milford

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Intellectual delay, Developmental disorder, others

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

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital program called iCHART/cASAP, designed to help prevent suicide among teens. It supports pediatricians by using an app for safety planning and a mental health questionnaire to tailor treatment plans. Teens will also receive motivational texts and access to educational modules. The trial seeks teens aged 12-17 who have recently experienced moderate to severe depression or suicidal thoughts and have a smartphone. As an unphased trial, this study provides a unique opportunity for teens to access innovative digital support tools and contribute to important mental health research.

Will I have to stop taking my current medications?

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

What prior data suggests that this digital intervention is safe for adolescents?

Research has shown that digital tools like iCHART/cASAP are generally safe. These tools, studied separately, have shown promise in reducing the risk of suicidal thoughts. Although digital health tools are mostly safe, they can sometimes cause mood issues or worsen mental health symptoms in a small number of people.

This study has not yet reached a stage that provides complete safety data. However, since these tools have been used before, most people are likely to tolerate them well. The researchers aim to offer a safe and effective way to support young people at risk of suicide. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iCHART/cASAP intervention for suicide prevention because it offers a digital approach that integrates cutting-edge technology to enhance traditional care. Unlike the standard treatment, which typically involves paper safety plans and referrals, iCHART/cASAP includes a Safety Planning App that streamlines care directly through smartphones. Additionally, it features a computerized intervention with self-led modules and text message support, providing ongoing motivation and personalized mental health insights. These elements aim to engage youth more effectively by leveraging technology for immediacy and accessibility, potentially leading to better adherence and outcomes.

What evidence suggests that this trial's digital interventions could be effective for suicide prevention among adolescents?

Research shows that the iCHART/cASAP program, which participants in this trial may receive, is a promising digital method for preventing suicide among teenagers. Previous studies tested its effectiveness and found that it can help lower the risk of suicide and depression. The program uses technology to offer safety planning and stress management skills, which are crucial for handling tough times. Additionally, the iCHART/cASAP program includes a mental health check and sends supportive text messages to keep teens engaged with their treatment plan. These features aim to create a personalized and supportive experience for at-risk youth, increasing the likelihood they will adhere to their care plan. ^{1 2 3 6 7}

Who Is on the Research Team?

Stephanie Stepp

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for young people who are experiencing depression, suicidal thoughts or behaviors, or have engaged in self-harm. It's aimed at those who could benefit from suicide prevention strategies within pediatric primary care settings.

Inclusion Criteria

Youth: Parent/legal guardian consents for youth to be in study

Youth: English fluency and literacy-own a smart phone or device

Youth: PHQ-9M score indicating moderate or severe depression or suicidal ideation in past month, past 2 weeks, or an attempt in their lifetime

Exclusion Criteria

I can understand and answer questions about my health.

I have been diagnosed with a developmental disorder.

Youth: Evidence of intellectual delay

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

3-month baseline period where all practices provide usual care

3 months

Intervention

Practices are randomized to offer the iCHART-cASAP intervention at one of the four, 3-month intervals

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• iCHART/cASAP
• Treatment as usual

Trial Overview The study is testing a digital suicide prevention tool called iCHART/cASAP against the standard treatment usually given. The goal is to see if this new method can help reduce the risk of suicide among adolescents in a primary care environment.

How Is the Trial Designed?

Group I: iCHART/cASAP Experimental Treatment 1 Intervention

An intervention previously studied in the ETUDES Center along with a computerized version of our As Safe As Possible intervention. 1. Safety Planning App for suicidal youth which enables a primary care provider to streamline the gold standard of care for those with current suicidality symptoms through an app; 2. Mental Health Screener questionnaire that gathers additional mental health symptoms, treatment preferences, and family's readiness for treatment engagement to help a primary care provider make a personalized, tailored treatment plan a suicidal youth is more likely to adhere to; 3. Text Messages which aims to provide texts for 2-3 weeks to motivate you to engage with the safety plan and recommended treatment following the patient visit. 4. cASAP is a computerized version of the As Safe As Possible intervention that offers self-led modules with psychoeducation about safety planning, cognitive-behavioral skills to cope with distress, and facilitate collaboration with parents.

Group II: Treatment as usual Active Control 1 Intervention

When patients disclose suicidal ideation on the PHQ-9, a treatment as usual approach will be given to the patient and their parent by the pediatrician which includes a paper safety plan will be completed and given to the patient and a referral placed for the patient to begin behavioral health services.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Pediatric Research in Office Settings

Collaborator

Trials

2

Recruited

1,900+

Published Research Related to This Trial

A newly developed smoking cessation web app, tested in both Spanish and English, showed significant improvements in user engagement with its third version, which featured a more appealing design and easier access to key tools.

Despite the increased engagement with the app's features, follow-up rates remained low, highlighting the need for ongoing strategies to maintain user participation in online smoking cessation interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and usability of a Spanish/English smoking cessation website: lessons learned. Bond, MH., Bunge, EL., Leykin, Y., et al.[2022]

Among 311,567 users of the iCoach app for smoking cessation, 26,785 steady users were identified, with more intensive app use linked to higher rates of smoking cessation, improved quitting stages, and increased self-efficacy over time.

The most significant improvements in smoking-related outcomes were observed within the first 3 months of app use, particularly among older users and women, who were more likely to engage with the app intensively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Smoking Cessation App Ex-Smokers iCoach and Associations With Smoking-Related Outcomes Over Time in a Large Sample of European Smokers: Retrospective Observational Study. Mansour, MB., Busschers, WB., Crone, MR., et al.[2023]

In a study involving 584 participants, the CureApp Smoking Cessation (CASC) system, which includes a smartphone app and a mobile CO checker, significantly improved the continuous abstinence rate (CAR) from smoking compared to a control app, with rates of 63.9% versus 50.5% from weeks 9 to 24.

The CASC system also showed a higher CAR from weeks 9 to 52 (52.3% vs. 41.5%), indicating its effectiveness in supporting long-term smoking cessation without any reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a smoking cessation smartphone application with a carbon monoxide checker. Masaki, K., Tateno, H., Nomura, A., et al.[2023]

Digital interventions for smoking cessation in patients with serious mental illness (SMI) show promise, with the mSMART MIND program achieving 7-day abstinence rates between 16-40%.

The study found that while adverse events were rare, the overall quality of the included studies was fair to good, highlighting the need for larger trials with standardized measures to better assess effectiveness and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of digital interventions for smoking cessation in patients with serious mental illness. Martinez Agulleiro, L., Patil, B., Firth, J., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06194331

Optimizing Suicide Prevention Strategies for Pediatric ... The study will adapt and collect preliminary effectiveness data on a digital suicide prevention intervention that can be delivered in pediatric primary care ...

2. reporter.nih.gov reporter.nih.gov/search/14EBC10F4A88C0D57598B8961CAA4A01A2FFCEB861BF/project-details/11063233

Optimizing Suicide Prevention Strategies for Pediatric Primary ... In our prior work, we developed and tested the effectiveness of an integrated adolescent suicide prevention intervention, iCHART (integrated Care to Help At- ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/31/NCT06194331/Prot_000.pdf

Study Protocol We will compare iCHART-cASAP vs usual care and the impact on suicide risk and depression assessed at 1-, 3-, and 6-months follow-up. Finally, guided by the ...

4. withpower.com withpower.com/trial/phase-depression-1-2024-63bc2

Digital Intervention for Suicide Prevention The iCHART/cASAP treatment is unique because it is a digital intervention, which means it uses technology to help prevent suicide, unlike traditional methods ...

5. nimh.nih.gov nimh.nih.gov/health/trials/suicide-prevention

Suicide Prevention - National Institute of Mental Health (NIMH) This protocol will test the effectiveness of an intervention, iCHART (integrated Care to Help At-Risk Teens) and facilitate recruitment for other studies in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11548921/

Adverse Events Reporting in Digital Interventions Evaluations ... While overall results support the safety of DHIs, DHIs were linked to mood problems and psychosis exacerbation in a few cases. Additionally, 27% ...

7. jaacap.org jaacap.org/article/S0890-8567(24)01014-1/pdf

PRACTICE-BASED SUICIDE PREVENTION ... iCHART consists of a suite of tools developed and tested indi- vidually but never used together: enhanced screen for relevant comorbidity, a personalized safety ...