Clinical Trial for Integrated Care to Help At Risk Teen (iCHART) Intervention
Recruiting · NCT05748730 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Pittsburgh
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
13 locations listed across 2 US states.
- 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