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iCHART Intervention for Teen Suicidal Behavior

N/A

Recruiting

Led By Stephanie Stepp, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Caregivers/parents must be able to speak English.

Be younger than 65 years old

Must not have

current manic or psychotic episode, presence of a life-threatening medical condition requiring immediate treatment, intellectual or developmental disability precluding comprehension of study procedure.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if an intervention, iCHART, can help reduce the risk of suicidal behavior in teens. 900 teens will be randomly assigned to either iCHART or usual treatment. Results will be assessed to see if iCHART can decrease suicidal-related events by 50%.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

As this is an intervention focused on care coordination rather than medication, traditional side effects aren't applicable. However, there may be emotional or psychological impacts from participating in the therapy sessions which will vary individually.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I (or my caregiver/parent) can speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Depression Severity

Suicidal Ideation and Behavior

Secondary study objectives

Application Utilization

Intervention Acceptability (intervention liked by study population)

Intervention Appropriateness (intervention fits or matches study population needs)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: iCHARTExperimental Treatment1 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 Control1 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.

0 / 2Eligibility criteria met