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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

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 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

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.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,762 Previous Clinical Trials
16,347,103 Total Patients Enrolled
121 Trials studying Depression
33,055 Patients Enrolled for Depression
University of OregonOTHER
84 Previous Clinical Trials
43,111 Total Patients Enrolled
11 Trials studying Depression
2,942 Patients Enrolled for Depression
Columbia UniversityOTHER
1,471 Previous Clinical Trials
2,535,450 Total Patients Enrolled
47 Trials studying Depression
37,272 Patients Enrolled for Depression

Media Library

iCHART Clinical Trial Eligibility Overview. Trial Name: NCT05748730 — N/A
Depression Research Study Groups: iCHART, Treatment As Usual (TAU)
Depression Clinical Trial 2023: iCHART Highlights & Side Effects. Trial Name: NCT05748730 — N/A
iCHART 2023 Treatment Timeline for Medical Study. Trial Name: NCT05748730 — N/A
~547 spots leftby Apr 2027
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