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

Trial Summary

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 data supports the effectiveness of the treatment iCHART/cASAP for suicide prevention?

Digital interventions, like those used for smoking cessation, have shown promise in helping people quit smoking, which suggests they might also be effective for other behavior changes, such as suicide prevention. For example, digital cognitive behavioral therapy (CBT) has been effective in helping people stop smoking, indicating that similar digital approaches could support mental health improvements. ^{1 2 3 4 5}

Is the digital intervention for suicide prevention safe for humans?

The studies on digital interventions for smoking cessation, which may be similar to the digital intervention for suicide prevention, reported no specific adverse events, suggesting they are generally safe for humans. ^{1 3 5 6 7}

How is the iCHART/cASAP treatment for suicide prevention different from other treatments?

The iCHART/cASAP treatment is unique because it is a digital intervention, which means it uses technology to help prevent suicide, unlike traditional methods that might rely on face-to-face therapy or medication. This approach can provide more accessible and immediate support for individuals in need. ^{1 2 4 5 8}

What is the purpose of this trial?

Increasing rates of suicidal thoughts and behaviors among adolescents must be addressed. The study will adapt and collect preliminary effectiveness data on a digital suicide prevention intervention that can be delivered in pediatric primary care settings by front line pediatricians. The study has the potential to offer a low-cost and scalable primary care intervention that may decrease risk of suicide among at-risk youth.

Research Team

Stephanie Stepp

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Canada 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Cancer survivors' views on digital support for smoking cessation and alcohol moderation: a survey and qualitative study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A systematic review of digital interventions for smoking cessation in patients with serious mental illness. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Long-Term Effectiveness of a Clinician-Assisted Digital Cognitive Behavioral Therapy Intervention for Smoking Cessation: Secondary Outcomes From a Randomized Controlled Trial. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Can a smartphone application help Hispanic/Latinx adults quit smoking? A randomized trial secondary analysis. [2023]

6. China pubmed.ncbi.nlm.nih.gov

Development and usability of a Spanish/English smoking cessation website: lessons learned. [2022]

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

A randomized controlled trial of a smoking cessation smartphone application with a carbon monoxide checker. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

Efficacy and utilization of smartphone applications for smoking cessation among low-income adults: Secondary analysis of the iCanQuit randomized trial. [2023]