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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month follow up
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I (or my caregiver/parent) can speak English.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Depression Severity
Suicidal Ideation and Behavior
Secondary outcome measures
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: 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); 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; 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
1,716 Previous Clinical Trials
16,345,554 Total Patients Enrolled
119 Trials studying Depression
33,195 Patients Enrolled for Depression
Children's Hospital of PhiladelphiaOTHER
706 Previous Clinical Trials
8,570,540 Total Patients Enrolled
16 Trials studying Depression
1,468 Patients Enrolled for Depression
University of OregonOTHER
80 Previous Clinical Trials
45,859 Total Patients Enrolled
11 Trials studying Depression
2,795 Patients Enrolled for Depression

Media Library

iCHART Clinical Trial Eligibility Overview. Trial Name: NCT05748730 — N/A
Depression Research Study Groups: Treatment As Usual (TAU), iCHART
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the objective of this medical experiment?

"This clinical trial is intended to measure the efficacy of an intervention, iCHART, on Suicidal Ideation and Behavior over a 12 Month Follow Up period. Secondary outcomes encompass Application Utilization (i.e., usage metrics for components/portals), Intervention Acceptability (assessed by 4 items in AIM scale 1-5; higher scores indicative of greater acceptability) and Usability (as evaluated with PSSUQ, 7 point Likert Scale + NA option; lower score implies better performance & satisfaction)."

Answered by AI

Are individuals over the age of fifty-years-old able to participate in this investigation?

"The parameters for this medical trial state that 12 to 18 year olds can participate. There are 270 studies suitable for adolescents and 969 clinical trials targeting patients 65 years old or older."

Answered by AI

How many venues are hosting this research experiment?

"This research is recruiting from 5 different sites, including Philadelphia, Pittsburgh and West Chester. To minimize the burden of travelling for enrolled participants, we suggest selecting your closest location to enroll in this study."

Answered by AI

What specific criteria must potential participants meet to enroll in this trial?

"In order to be eligible for this clinical trial, potential enrollees must have a history of depression and suicidal ideation while being between the ages of 12-18. Approximately 900 participants will ultimately join the study."

Answered by AI

Are fresh participants still being enrolled in this research endeavor?

"The information found on clinicaltrials.gov states that this research project is actively recruiting members. This trial was created and last updated on the 23rd of January, 2023 and 17th of February, 2023 respectively."

Answered by AI

What is the highest capacity of enrollees for this experiment?

"Affirmative, clinicaltrials.gov confirms that this investigation is actively recruiting participants since it was first published on January 23rd 2023 and last updated February 17th 2023. The trial hopes to enroll up to 900 individuals from 5 different medical centres."

Answered by AI
~600 spots leftby Apr 2027