iCHART Intervention for Teen Suicidal Behavior

Recruiting at 13 trial locations

Overseen By Brandie George-Milford, MA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Manic, Psychotic, Intellectual disability, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new program called iCHART, designed to help teens at risk of suicidal behavior. iCHART combines a mobile app for safety planning, a mental health questionnaire, and supportive text messages to encourage adherence to treatment plans. The trial compares this approach with the usual care provided by doctors to determine if iCHART can more effectively reduce suicidal events. Teens aged 12-18 who have recently experienced depression or suicidal thoughts may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity for teens to contribute to innovative mental health solutions.

Will I have to stop taking my current medications?

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

What prior data suggests that this protocol is safe for teens?

Research has shown that the iCHART program, which includes a safety planning app, a mental health check, and supportive text messages, has been studied before. These tools aim to assist teens at risk of suicide by simplifying the process of following a safety plan and connecting with mental health resources.

In past studies, iCHART was safely used with teens, with no reports of serious side effects. Instead, it appeared to reduce suicidal thoughts and behaviors. The safety planning app replaces a paper version, enhancing usability, while the supportive text messages encourage adherence to personalized care plans. This approach has been tested with teens before without major problems, indicating it is well-tolerated.

Overall, while every treatment carries some risks, iCHART appears safe based on past research. It provides a set of tools to help teens manage their mental health more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iCHART intervention for teen suicidal behavior because it integrates modern technology into traditional care. Unlike the standard paper-based safety plans, iCHART uses a Safety Planning App that allows primary care providers to efficiently create personalized care plans via a digital platform. Additionally, it includes a Mental Health Screener to gather detailed information about mental health symptoms and treatment preferences, enabling more tailored and effective treatment strategies. The intervention also sends supportive text messages to encourage engagement with the safety plan and recommended treatments, providing ongoing support beyond the initial patient visit. This combination of technology and personalized care offers a promising new approach to improve adherence and outcomes for suicidal youth.

What evidence suggests that the iCHART intervention is effective for reducing teen suicidal behavior?

Research shows that iCHART, one of the interventions in this trial, can reduce suicide-related events by 50% compared to regular care. This program includes a safety planning app, a mental health screener for creating personalized plans, and motivational text messages. Early findings suggest that digital tools in primary care improve safety and treatment involvement for at-risk teens. Previous studies have demonstrated that similar methods help create effective and personalized safety plans. Overall, iCHART aims to better identify and manage risks in teens, potentially leading to fewer suicide-related incidents. Participants in the trial will either receive the iCHART intervention or Treatment As Usual (TAU), which involves standard care practices. ^{2 6 7 8 9}

Who Is on the Research Team?

Stephanie Stepp, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for English-speaking teens aged 12-18 with depression or suicidal behavior, and their parents who are over 18 and speak English. Teens must have had recent suicidal thoughts or a history of attempts. Parents need to be biological/adoptive or legal guardians. Teens with severe mental conditions, life-threatening medical issues, intellectual disabilities, or without access to a phone/tablet are excluded.

Inclusion Criteria

Only 1 parent/caregiver will be engaged in research, but in case 1 parent is unavailable, the other may be engaged (meaning it doesn't have to be the same parent participating in assessments/interviews throughout youth study participation).

CAREGIVERS/PARENTS

Parents are considered biological/adoptive parents or have court documentation that they can provide consent for research as a legal guardian of a youth.

Exclusion Criteria

I do not have a severe mental health crisis, life-threatening condition needing immediate care, or a cognitive disability that prevents understanding of the study.

Exclusion criteria include conditions that might impair their ability to effectively deploy ETUDES interventions, including:

There are no specific exclusion criteria for caregivers and providers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are enrolled in the iCHART intervention or Treatment As Usual (TAU) to test the effectiveness in reducing suicide-related events

6 months

Regular visits as per primary care provider's schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of suicidal ideation and behavior

12 months

What Are the Treatments Tested in This Trial?

Interventions

• iCHART
• Treatment As Usual

Trial Overview The iCHART intervention aims to reduce suicide-related events in at-risk teens by half compared to usual treatment (TAU). The study will enroll 900 adolescents in a randomized controlled trial comparing iCHART's effectiveness against TAU while assessing factors that affect implementation like acceptability and cost.

How Is the Trial Designed?

Group I: iCHART Experimental Treatment 1 Intervention

iCHART is an intervention that includes 3 components previously studied in within the ETUDES Center including a: 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 (instead of a paper based version); 2. Mental Health Screener questionnaire that gathers additional mental health symptoms, treatment preferences, and family's readiness for treatment engagement to help 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. Participants will receive usual care at their pediatric primary care practice following screening including information, psychoeducation, and referral to a mental health treatment provider.

Group II: Treatment As Usual (TAU) Active Control 1 Intervention

Participants in this group will receive usual care from their primary care provider or mental health care provider which may include development of a paper safety plan.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

University of Oregon

Collaborator

Trials

91

Recruited

46,700+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The Concise Health Risk Tracking Self-Report (CHRT-SR14) effectively predicts suicide attempts and events in high-risk adolescents, showing at least 80% sensitivity, which is crucial for early intervention.

In a study of 251 adolescents undergoing intensive outpatient treatment, those who experienced suicidal events had significantly higher scores on the CHRT-SR14, indicating its potential utility in identifying individuals at greater risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting future suicidal events in adolescents using the Concise Health Risk Tracking Self-Report (CHRT-SR). Mayes, TL., Killian, M., Rush, AJ., et al.[2021]

The study will evaluate a blended intervention combining online cognitive-behavioral therapy (CBT) sessions with face-to-face therapy to reduce suicidal ideation in adolescents, using a cluster randomized controlled trial design in school settings.

Outcomes will be measured at multiple follow-up points (post-intervention, 3, 6, and 12 months) to assess not only suicidal ideation but also related factors like depressive symptoms and emotional regulation, providing comprehensive insights into the intervention's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the Effectiveness of a Blended Intervention to Reduce Suicidal Ideation among School Adolescents in Chile: A Protocol for a Cluster Randomized Controlled Trial. Núñez, D., Gaete, J., Meza, D., et al.[2022]

In a study of 167 adolescents aged 13-18 who attempted suicide, 25.5% did not attend any follow-up care, highlighting a significant gap in post-discharge support for this vulnerable group.

Adolescents who complied with follow-up care tended to have more severe mental health issues, such as higher levels of depression and anxiety, suggesting that those in greater need of support may be less likely to seek it, but scheduling follow-up appointments before discharge improved compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive factors of post-discharge follow-up care among adolescent suicide attempters. Granboulan, V., Roudot-Thoraval, F., Lemerle, S., et al.[2019]

The review highlights that there are effective treatment models and service delivery strategies available for addressing depression and suicidality in adolescents, emphasizing the importance of evidence-based care.

It calls for future research and quality improvement initiatives to better connect scientific findings with community practices, aiming to enhance mental health and well-being among young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving care for depression and suicide risk in adolescents: innovative strategies for bringing treatments to community settings. Asarnow, JR., Miranda, J.[2023]

In a study of 1356 suicidal adolescents, mental health service use was found to be low (around 11%-30%) despite the high risk for suicide and depression, highlighting a significant gap in care.

The only factor that significantly predicted increased mental health service use was receiving routine physical care, suggesting that integrating physical and mental health services could improve access to necessary mental health support for at-risk youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Care Resources and Mental Health Service Use Among Suicidal Adolescents. LeCloux, M., Maramaldi, P., Thomas, K., et al.[2022]

The intervention designed for adolescents at risk of suicide is based on effective strategies used for suicidal adults, focusing on reducing suicide risk and addressing emotional distress and interpersonal issues.

This program consists of five intensive weekly sessions followed by three months of email follow-up, aiming to provide immediate support and foster hope for both adolescents and their parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-brief crisis interpersonal psychotherapy based intervention for suicidal children and adolescents. Klomek, AB., Catalan, LH., Apter, A.[2021]

The study analyzed responses from 49 patients regarding helpful aspects of their treatment for suicidal risk, leading to the development of a reliable coding system to identify major themes in their experiences.

Insights gained from 52 patients on what they learned from their clinical care can inform future suicide-specific treatments, highlighting the importance of patient feedback in improving therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Treatment of Suicidal Risk. Schembari, BC., Jobes, DA., Horgan, RJ.[2022]

In a randomized controlled trial with 148 U.S. Army Soldiers, the Collaborative Assessment and Management of Suicidality (CAMS) was found to significantly reduce suicidal ideation (SI) compared to enhanced care as usual (E-CAU) by 3 months, with a strong effect size (Cohen's d = 0.93).

Both CAMS and E-CAU led to improvements in various behavioral health outcomes, but CAMS showed a notable advantage in reducing suicidal thoughts, highlighting its potential as an effective intervention for Soldiers with significant suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of the Collaborative Assessment and Management of Suicidality versus Enhanced Care as Usual With Suicidal Soldiers. Jobes, DA., Comtois, KA., Gutierrez, PM., et al.[2019]

The CAMS-4Teens intervention was found to be feasible and acceptable for treating adolescents with suicidal thoughts, with high adherence from clinicians during the pilot trial involving 22 participants.

Preliminary results indicated a large effect size in reducing suicidal thoughts among participants, suggesting that CAMS-4Teens may be as effective as established interventions for adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative Assessment and Management of Suicidality for Teens: A Promising Frontline Intervention for Addressing Adolescent Suicidality. Adrian, M., Blossom, JB., Chu, PV., et al.[2022]

The integrated suicide-violence prevention program significantly improved self-esteem among adolescents, with 24 participants in the experimental group showing notable differences compared to the control group of 25.

The program also effectively reduced aggression and suicidal ideation in participants, indicating its potential as a valuable strategy for promoting mental health in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The development of an integrated suicide-violence prevention program for adolescents]. Park, HS.[2022]

The evaluation of adolescent suicide attempters focuses on identifying risk factors and motivations that could lead to future attempts, which helps tailor the intensity and type of care needed.

Key treatment strategies include creating a no-suicide contract, providing family education, addressing co-occurring mental health issues, and improving social skills, all aimed at reducing the likelihood of future suicide attempts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The aftercare of adolescents with deliberate self-harm. Brent, DA.[2022]

Over 90% of adolescents recently hospitalized for suicide risk reported having access to their safety plans after discharge, indicating high retention and potential for use during critical periods.

While safety plan use and suicidal ideation both declined over time, the relationship between them varied by sex: girls showed a correlation in changes, while boys' safety plan use decreased regardless of their suicidal ideation changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety plan use in the daily lives of adolescents after psychiatric hospitalization. May, AM., Al-Dajani, N., Ballard, ED., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04000399

BRITEPath, Component 3 of iCHART (Integrated Care to ... BRITEPath (BP) aims to support co-located mental health clinicians in the development of a high quality, effective, and personalized safety plan for ...

2. trialx.com trialx.com/clinical-trials/listings/266717/clinical-trial-for-integrated-care-to-help-at-risk-teen-ichart-intervention/?&radius=50

Clinical Trial for Integrated Care to Help At Risk Teen ... Based on previous work, the investigators hypothesize that iCHART, compared to TAU, will decrease suicidal-related events by 50%, and the ...

3. reporter.nih.gov reporter.nih.gov/project-details/10649853

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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12378765/

Suicide Prevention in Youth - PMC This review presents new research pertinent to youth suicide prevention with a focus on suicide risk screening; therapeutic interventions, ...

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

Study Protocol The proposed study will help Pediatric Primary Care (PPC) providers to identify and manage adolescents at risk for suicidal behavior, which will ultimately ...

6. 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- ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05748730/clinical-trial-for-integrated-care-to-help-at-risk-teen-ichart-intervention

Clinical Trial for Integrated Care to Help At Risk Teen ... Based on previous work, the investigators hypothesize that iCHART, compared to TAU, will decrease suicidal-related events by 50%, and the ...

8. trial.medpath.com trial.medpath.com/clinical-trial/8d39d0261263c078/britepath-component-3-ichart

BRITEPath, Component 3 of iCHART (Integrated Care to Help ... Hypothesis: The use of BRITEPath will decrease depressive symptoms, distress, and suicidality (any self-injurious ideation, urges, or behavior) as well as ...

9. publications.aap.org publications.aap.org/pediatrics/article/153/1/e2023064800/196189/Suicide-and-Suicide-Risk-in-Adolescents

Suicide and Suicide Risk in Adolescents | Pediatrics Suicide is the second leading cause of death for 10- to 24-year-olds in the United States and is a global public health issue.