Actively Recruiting

Phase Not Applicable
Age: 12Years - 18Years
All Genders
ID05748730

The Center for Enhancing Triage and Utilization for Depression and Emergent Suicidality (ETUDES) in Pediatric Primary Care-iCHART Randomized Controlled Trial

Led by University of Pittsburgh · Updated on 2026-06-04

900

Participants Needed

13

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Pittsburgh

Lead Sponsor

C

Children's Hospital of Philadelphia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of the iCHART (integrated Care to Help At-Risk Teens) intervention for adolescents aged 12 to 18 who are experiencing depression or suicidal behavior. This study aims to reduce suicide-related events by comparing iCHART to usual treatment in a randomized controlled trial including 900 participants. The study also examines factors that affect treatment response and uses implementation science to assess barriers, facilitators, and outcomes like acceptability and feasibility to support health equity. iCHART combines three main parts: a Safety Planning App that helps providers deliver care through an app instead of paper, a Mental Health Screener questionnaire to personalize treatment plans, and a series of text messages over 2 to 3 weeks to encourage engagement with safety plans and treatment. Participants are randomly assigned to either receive iCHART or treatment as usual, which may include a paper safety plan and standard care from their providers. Participants will be actively involved through mental health assessments at baseline and follow-up points up to 12 months, including evaluations of depression severity and suicidal thoughts and behaviors. The study also tracks service use, app usage, and participants' views on the intervention's acceptability, usability, feasibility, and appropriateness. This comprehensive monitoring helps understand how well iCHART works and informs future use in pediatric care settings.

CONDITIONS

Brief Title

Clinical Trial for Integrated Care to Help At Risk Teen (iCHART) Intervention

Who Can Participate

Age: 12Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Youth aged 12 to 18 years who speak English
  • Youth with current depression or suicidal behavior as defined by specific questionnaire scores or history
  • Parents or caregivers aged 18 or older who can provide consent and participate in the study
  • Only one parent or caregiver per youth will participate in assessments
  • 50% of youth with depression scores will also screen positive for suicide risk
Not Eligible

You will not qualify if you...

  • Youth currently experiencing a manic or psychotic episode
  • Youth with a life-threatening medical condition requiring immediate treatment
  • Youth with intellectual or developmental disabilities that prevent understanding study procedures
  • Youth without access to a phone or tablet needed for the intervention
  • Caregivers who are not biological parents or court-appointed guardians of the youth

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Outpatient Treatment

Duration - 2 to 3 weeks

Participants receive either the iCHART intervention, which includes a safety planning app, a mental health screener, and personalized text messages for 2-3 weeks to support engagement, or treatment as usual with standard care such as a paper safety plan. Both groups continue usual care at their pediatric primary care practice.

1 baseline visit and multiple follow-up contacts during intervention period

Follow-up Monitoring

Duration - Up to 12 months

Participants are monitored for suicide-related events, depression severity, and service utilization over 12 months following treatment to assess the effectiveness and engagement with the intervention or usual care.

Visits at 1 month, 3 months, 6 months, and 12 months follow-up

Trial Site Locations

Total: 13 locations

1

Gibbsboro

Gibbsboro, New Jersey, United States, 08026

Actively Recruiting

2

Conemaugh Memorial Medical Center-Family Medicine

Johnstown, Pennsylvania, United States, 15905

Actively Recruiting

3

CHOP Primary Care, CHOP Campus

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

4

Roxborough

Philadelphia, Pennsylvania, United States, 19128

Actively Recruiting

5

CHOP Primary Care, Cobbs Creek

Philadelphia, Pennsylvania, United States, 19139

Actively Recruiting

6

Karabots

Philadelphia, Pennsylvania, United States, 19139

Actively Recruiting

7

Children's Community Pediatrics (CCP) of Children's Hospital of Pittsburgh UPMC

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

8

UPMC Center for Adolescent and Young Adult Health

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

9

UPMC Family Medicine

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

10

Kids Plus Pediatrics (KPP)

Pittsburgh, Pennsylvania, United States, 15217

Actively Recruiting

11

Berks Community Health Center

Reading, Pennsylvania, United States, 19604

Actively Recruiting

12

Springfield

Springfield, Pennsylvania, United States, 19064

Actively Recruiting

13

CHOP Primary Care, West Chester

West Chester, Pennsylvania, United States, 19380

Actively Recruiting

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Research Team

B

Brandie George-Milford, MA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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