Recruiting

iCHART Intervention

Sponsor:

University of Pittsburgh

Code:

NCT05748730

Conditions

Suicide and Depression

Adolescent Behavior

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

iCHART

Treatment As Usual

Study Details

Brief 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.

Conditions

Suicide and Depression

Adolescent Behavior

Study ID

NCT05748730

Start date

Jan 26, 2023

Status verified date

Jun, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • YOUTH

  • Youth will be age 12-18 and speak English.
  • Youth will have current depression or suicidal behavior. Suicidal behavior for iCHART (N=900) is defined as past suicidal thoughts in the past two weeks as indicated by PHQ-9M item #9 ≥ 1, and/or past month suicidal thoughts, and/or prior history of attempt as indicated by items on the PHQ-9M; and 300 who screen positive for depression (PHQ-9M ≥ "11")
  • 50% of the 300 youth with PHQ-9M ≥ "11" will also be positive for suicide risk as defined for iCHART.
  • CAREGIVERS/PARENTS

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

Exclusion Criteria:

  • YOUTH

  • Exclusion criteria include conditions that might impair their ability to effectively deploy ETUDES interventions, including:
  • current manic or psychotic episode, presence of a life-threatening medical condition requiring immediate treatment, intellectual or developmental disability precluding comprehension of study procedure. The latter will will be assessed by parental report of placement in self-contained Special Education classes, EHR review, and during the consent/assent and/or baseline to determine if the participant is not understanding research procedures.
  • Participants without access to a phone and/or tablet to interact with components 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 are not the biological parent or court-appointed guardian of the youth being interviewed.

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: iCHART

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.

active comparator: Treatment As Usual (TAU)

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.

Interventions

iCHART

The Safety Planning App will guide primary care providers or mental health clinicians in the use of an emotion regulation and safety planning app (BRITE) to be loaded on the phone of depressed and suicidal adolescents in order to improve depression and reduce the likelihood of a suicide attempt.

The Mental Health Screener is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.

The Text Messages is a personalized text messaging intervention for patients and parents that targets engagement with the safety plan to increase the likelihood that a depressed or suicidal patient will maintain or initiate recommended services.

Participants will receive usual care at their pediatric primary care practice following screening including information, psychoeducation, and referral to a mental health treatment provider.

Treatment As Usual

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.

Primary outcome measure

  • Depression Severity [ Time Frame: Baseline ]
  • Depression Severity [ Time Frame: 1 Month Follow Up ]
  • Depression Severity [ Time Frame: 3 Month Follow Up ]
  • Depression Severity [ Time Frame: 6 Month Follow Up ]
  • Depression Severity [ Time Frame: 12 Month Follow Up ]
  • Suicidal Ideation and Behavior [ Time Frame: Baseline ]
  • Suicidal Ideation and Behavior [ Time Frame: 1 month follow up ]
  • Suicidal Ideation and Behavior [ Time Frame: 3 month follow up ]
  • Suicidal Ideation and Behavior [ Time Frame: 6 month follow up ]
  • Suicidal Ideation and Behavior [ Time Frame: 12 month follow up ]

Central Contacts and Locations

Central contacts

Brandie George-Milford, MA

412-246-5629georgeba2@upmc.edu

Locations

Gibbsboro

Recruiting

Gibbsboro, New Jersey, United States, 08026

Contacts

Jeffrey Fendrick, MD

856-783-2802fendrickj@chop.edu

Conemaugh Memorial Medical Center-Family Medicine

Recruiting

Johnstown, Pennsylvania, United States, 15905

Contacts

Jeannie Spencer, MD

(814) 534-9106JSpence@conemaugh.org

CHOP Primary Care, CHOP Campus

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Kathleen Zsolway, DO

215-590-2178zsolway@chop.edu

Roxborough

Recruiting

Philadelphia, Pennsylvania, United States, 19128

Contacts

Maria Dugan, MD

2154833444duganm@chop.edu

CHOP Primary Care, Cobbs Creek

Recruiting

Philadelphia, Pennsylvania, United States, 19139

Contacts

Andrea McGeary, MD

215-476-2223mcgeary@chop.edu

Karabots

Recruiting

Philadelphia, Pennsylvania, United States, 19139

Contacts

Kari Draper, MD

267-425-9800draper@chop.edu

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

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Chris Cepullio, BSN, RN, CPPS

724-933-1100cepulliocm2@upmc.edu

UPMC Center for Adolescent and Young Adult Health

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Ana Radovic, MD

412-692-6677Ana.Radovic@chp.edu

UPMC Family Medicine

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Tracey Conti, MD

412-383-2378conttd@upmc.edu

Jonathan Raviotta, MD

412-383-2378jraviotta@pitt.edu

Kids Plus Pediatrics (KPP)

Recruiting

Pittsburgh, Pennsylvania, United States, 15217

Contacts

Lisa Zur, MPH

412-521-6511Lisa.Zur@pediatricassociates.com

Berks Community Health Center

Recruiting

Reading, Pennsylvania, United States, 19604

Contacts

Helen Wooten

(610) 988-4838HWooten@berkschc.org

Springfield

Recruiting

Springfield, Pennsylvania, United States, 19064

Contacts

Jonathan Lee, MD

610-604-0888leejo@chop.edu

CHOP Primary Care, West Chester

Recruiting

West Chester, Pennsylvania, United States, 19380

Contacts

Wendy Wallace, DO

610-436-8611wallace@chop.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-06-04.