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

Adolescent Behavior Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

iCHART is an intervention that includes 3 components previously studied in within the ETUDES Center including the:

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 youth to engage with the safety plan and recommended treatment following the patient visit.

Aim 1. Test the effectiveness of iCHART in reducing suicide-related events at 6 months, the primary outcome, and examine mediators and moderators of treatment response. The investigators hypothesize: 1) iCHART will reduce suicide-related events and its effects will be mediated by increases in mental health referrals made by pediatric providers (any designated staff member, doctor, nurse on the treatment team); treatment engagement (i.e., follow through with mental health referrals), and safety planning (as evident by EHR reviews); 2) Individual-, family-, and neighborhood-level risk and protective factors will moderate response; and 3) Examine a predictive algorithm to examine heterogeneity of treatment response.

Aim 2. Examine barriers, facilitators, and implementation outcomes specifically, acceptability, feasibility, appropriateness, and cost for the predictive algorithm and iCHART to inform future implementation efforts and promote health equity. Barriers and facilitators that span multiple levels of context (e.g., aspects of clinic workflows, provider beliefs and knowledge) are expected to be uncovered. Further, incorporating the predictive algorithm and iCHART in pediatric primary care will be viewed as feasible, acceptable, and appropriate by youth, caregivers, and providers across different racial and ethnic groups. ;

Related Conditions & MeSH terms

• Adolescent Behavior
• Depression
• Suicide
• Suicide and Depression

• NCT number: NCT05748730
• Study type: Interventional
• Source: University of Pittsburgh
• Contact: Brandie George-Milford, MA
• Phone: 412-246-5629
• Email: georgeba2@upmc.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2023
• Completion date: April 30, 2027