Integrated care intervention for at-risk teens
The Center for Enhancing Triage and Utilization for Depression and Emergent Suicidality (ETUDES) in Pediatric Primary Care-iCHART RCT
This study is testing a new program called iCHART to see if it can help at-risk teens aged 12-18 who are dealing with depression or suicidal thoughts feel safer and get better treatment compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 13 sites (Gibbsboro, New Jersey and 12 other locations) |
| Trial ID | NCT05748730 on ClinicalTrials.gov |
What this trial studies
This intervention, known as iCHART, aims to reduce suicide-related events among adolescents aged 12-18 who are experiencing depression or suicidal behavior. The study will enroll 900 participants in a randomized controlled trial, comparing the iCHART intervention to standard treatment. iCHART includes a safety planning app, a mental health screener, and motivational text messages to enhance treatment engagement and safety planning. The effectiveness of iCHART will be evaluated over six months, focusing on its impact on mental health referrals and treatment adherence.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-18 who are experiencing current depression or suicidal behavior.
Not a fit: Patients who do not speak English or do not meet the criteria for current depression or suicidal behavior may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce suicidal behavior and improve mental health outcomes for at-risk adolescents.
How similar studies have performed: Previous studies have shown promise in using integrated care approaches for mental health, suggesting potential success for this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gibbsboro, New Jersey and 12 other locations
- Gibbsboro — Gibbsboro, New Jersey, United States (Recruiting)
- Conemaugh Memorial Medical Center-Family Medicine — Johnstown, Pennsylvania, United States (Recruiting)
- CHOP Primary Care, CHOP Campus — Philadelphia, Pennsylvania, United States (Recruiting)
- Roxborough — Philadelphia, Pennsylvania, United States (Recruiting)
- CHOP Primary Care, Cobbs Creek — Philadelphia, Pennsylvania, United States (Recruiting)
- Karabots — Philadelphia, Pennsylvania, United States (Recruiting)
- Children's Community Pediatrics (CCP) of Children's Hospital of Pittsburgh UPMC — Pittsburgh, Pennsylvania, United States (Recruiting)
- UPMC Center for Adolescent and Young Adult Health — Pittsburgh, Pennsylvania, United States (Recruiting)
- UPMC Family Medicine — Pittsburgh, Pennsylvania, United States (Recruiting)
- Kids Plus Pediatrics (KPP) — Pittsburgh, Pennsylvania, United States (Recruiting)
- Berks Community Health Center — Reading, Pennsylvania, United States (Recruiting)
- Springfield — Springfield, Pennsylvania, United States (Recruiting)
- CHOP Primary Care, West Chester — West Chester, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie Stepp, PhD — University of Pittsburgh
- Study coordinator: Brandie George-Milford, MA
- Email: georgeba2@upmc.edu
- Phone: 412-246-5629
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.