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

Last updated: July 17, 2025
Sponsor: University of Pittsburgh
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Suicide

Treatment

Treatment As Usual

iCHART

Clinical Study ID

NCT05748730
STUDY22020069
P50MH115838
  • Ages 12-18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • YOUTH

  • Youth will be age 12-18 and speak English.

  • Youth will have current depression or suicidal behavior. Suicidal behavior foriCHART (N=900) is defined as past suicidal thoughts in the past two weeks asindicated by PHQ-9M item #9 ≥ 1, and/or past month suicidal thoughts, and/orprior history of attempt as indicated by items on the PHQ-9M; and 300 whoscreen positive for depression (PHQ-9M ≥ "11")

  • 50% of the 300 youth with PHQ-9M ≥ "11" will also be positive for suicide riskas defined for iCHART.

  • CAREGIVERS/PARENTS

  • Parents/caregivers of youth in the study must be at least 18 years old andtheir child must be willing to participate in the study. Caregivers/parentsmust be able to speak English. Parents are considered biological/adoptiveparents or have court documentation that they can provide consent for researchas a legal guardian of a youth. Only 1 parent/caregiver will be engaged inresearch, but in case 1 parent is unavailable, the other may be engaged (meaning it doesn't have to be the same parent participating inassessments/interviews throughout youth study participation).

Exclusion

Exclusion Criteria:

  • YOUTH

  • Exclusion criteria include conditions that might impair their ability toeffectively deploy ETUDES interventions, including:

  • current manic or psychotic episode, presence of a life-threatening medicalcondition requiring immediate treatment, intellectual or developmentaldisability precluding comprehension of study procedure. The latter will will beassessed by parental report of placement in self-contained Special Educationclasses, EHR review, and during the consent/assent and/or baseline to determineif the participant is not understanding research procedures.

  • Participants without access to a phone and/or tablet to interact withcomponents of the intervention that require a phone will be excluded.

  • CAREGIVERS/PARENTS

  • There are no specific exclusion criteria for caregivers and providers. However,as mentioned in the inclusion criteria, caregivers will be excluded if they arenot the biological parent or court-appointed guardian of the youth beinginterviewed.

Study Design

Total Participants: 900
Treatment Group(s): 2
Primary Treatment: Treatment As Usual
Phase:
Study Start date:
January 26, 2023
Estimated Completion Date:
April 30, 2027

Study Description

iCHART is an intervention that includes 3 components previously studied in within the ETUDES Center including the:

  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 youth to engage with the safety plan and recommended treatment following the patient visit.

Aim 1. Test the effectiveness of iCHART in reducing suicide-related events at 6 months, the primary outcome, and examine mediators and moderators of treatment response. The investigators hypothesize: 1) iCHART will reduce suicide-related events and its effects will be mediated by increases in mental health referrals made by pediatric providers (any designated staff member, doctor, nurse on the treatment team); treatment engagement (i.e., follow through with mental health referrals), and safety planning (as evident by EHR reviews); 2) Individual-, family-, and neighborhood-level risk and protective factors will moderate response; and 3) Examine a predictive algorithm to examine heterogeneity of treatment response.

Aim 2. Examine barriers, facilitators, and implementation outcomes specifically, acceptability, feasibility, appropriateness, and cost for the predictive algorithm and iCHART to inform future implementation efforts and promote health equity. Barriers and facilitators that span multiple levels of context (e.g., aspects of clinic workflows, provider beliefs and knowledge) are expected to be uncovered. Further, incorporating the predictive algorithm and iCHART in pediatric primary care will be viewed as feasible, acceptable, and appropriate by youth, caregivers, and providers across different racial and ethnic groups.

Connect with a study center

  • Gibbsboro

    Gibbsboro, New Jersey 08026
    United States

    Active - Recruiting

  • Conemaugh Memorial Medical Center-Family Medicine

    Johnstown, Pennsylvania 15905
    United States

    Active - Recruiting

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

    McMurray, Pennsylvania 15317
    United States

    Site Not Available

  • CHOP Primary Care, CHOP Campus

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • CHOP Primary Care, Cobbs Creek

    Philadelphia, Pennsylvania 19139
    United States

    Active - Recruiting

  • Karabots

    Philadelphia, Pennsylvania 19139
    United States

    Active - Recruiting

  • Roxborough

    Philadelphia, Pennsylvania 19128
    United States

    Active - Recruiting

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

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Kids Plus Pediatrics (KPP)

    Pittsburgh, Pennsylvania 15217
    United States

    Active - Recruiting

  • UPMC Center for Adolescent and Young Adult Health

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • UPMC Family Medicine

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Berks Community Health Center

    Reading, Pennsylvania 19604
    United States

    Active - Recruiting

  • Springfield

    Springfield, Pennsylvania 19064
    United States

    Active - Recruiting

  • CHOP Primary Care, West Chester

    West Chester, Pennsylvania 19380
    United States

    Active - Recruiting

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