Actively Recruiting

Phase Not Applicable
Age: 12Years - 18Years
All Genders
NCT05748730

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

Led by University of Pittsburgh · Updated on 2025-07-18

900

Participants Needed

13

Research Sites

222 weeks

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

This protocol will test the effectiveness of an intervention, iCHART (integrated Care to Help At-Risk Teens) and facilitate recruitment for other studies in the larger ETUDES Center grant, which are focused on treatment development for target risk factors for suicidal behavior, specifically, sleep, anhedonia, and stress related to cybervictimization. This study will recruit 900 adolescents which will be enrolled in a randomized controlled trial to test iCHART and will be randomized to iCHART or treatment as usual (TAU). Based on previous work, the investigators hypothesize that iCHART, compared to TAU, will decrease suicidal-related events by 50%, and the effects will be mediated by increases in referrals, treatment engagement, and safety planning. The investigators will use implementation science methods to assess contextual factors (i.e., barriers and facilitators) and implementation outcomes specifically, acceptability, feasibility, appropriateness, and cost for our predictive algorithm and iCHART to inform future implementation efforts and promote health equity.

CONDITIONS

Official 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 who speak English
  • Youth with current depression or suicidal behavior as indicated by PHQ-9M criteria
  • 50% of youth with depression will also have suicide risk as defined
  • Parents/caregivers must be at least 18 years old and able to speak English
  • Parent/caregiver must be biological, adoptive, or legal guardian with consent ability
  • Only one parent/caregiver will participate in the study assessments
Not Eligible

You will not qualify if you...

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

AI-Screening

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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

CONTACT

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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