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

Launched by UNIVERSITY OF PITTSBURGH · Feb 17, 2023

Keywords

ClinConnect Summary

The iCHART (integrated Care to Help At-Risk Teens) clinical trial is designed to help improve the care of teenagers who are at risk for depression and suicidal behavior. The study will enroll 900 adolescents, aged 12 to 18, who are currently experiencing depression or suicidal thoughts. Participants will be randomly assigned to receive either the iCHART intervention, which aims to provide more support and resources, or the usual treatment they would normally get from healthcare providers. The goal is to see if iCHART can reduce suicidal thoughts and actions by making it easier for teens to get help and engage in treatment.

To be eligible, teens must be between 12 and 18 years old, speak English, and show signs of depression or suicidal thoughts. Their parents or caregivers, who must be at least 18 years old and also speak English, will need to agree to their participation. Participants can expect to receive support tailored to their needs, and their progress will be monitored throughout the study. Importantly, this trial is focused on understanding how to implement this new intervention effectively to ensure it benefits as many at-risk teens as possible in the future.

Gender

ALL

Eligibility 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.