RecruitingNot ApplicableNCT05748730

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

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


Sponsor

University of Pittsburgh

Enrollment

900 participants

Start Date

Jan 26, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the iCHART intervention — an integrated care program delivered through primary care settings — to support teenagers aged 12–18 who are experiencing depression or suicidal thoughts, connecting them with mental health resources and their families. **You may be eligible if...** - You are a young person aged 12–18 who speaks English - You have current depression symptoms (PHQ-9M score of 11 or higher) and/or suicidal thoughts in the past month - Your parent or caregiver is 18 or older and willing to participate **You may NOT be eligible if...** - You are currently experiencing a manic or psychotic episode - You have a life-threatening medical condition requiring immediate treatment - You have an intellectual or developmental disability that would prevent understanding the study materials - You are already receiving intensive mental health treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALiCHART

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.

BEHAVIORALTreatment 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.


Locations(13)

Gibbsboro

Gibbsboro, New Jersey, United States

Conemaugh Memorial Medical Center-Family Medicine

Johnstown, Pennsylvania, United States

CHOP Primary Care, CHOP Campus

Philadelphia, Pennsylvania, United States

Roxborough

Philadelphia, Pennsylvania, United States

CHOP Primary Care, Cobbs Creek

Philadelphia, Pennsylvania, United States

Karabots

Philadelphia, Pennsylvania, United States

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

Pittsburgh, Pennsylvania, United States

UPMC Center for Adolescent and Young Adult Health

Pittsburgh, Pennsylvania, United States

UPMC Family Medicine

Pittsburgh, Pennsylvania, United States

Kids Plus Pediatrics (KPP)

Pittsburgh, Pennsylvania, United States

Berks Community Health Center

Reading, Pennsylvania, United States

Springfield

Springfield, Pennsylvania, United States

CHOP Primary Care, West Chester

West Chester, Pennsylvania, United States

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NCT05748730


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