An interventional study of iCHART and Treatment As Usual in Suicide and Depression and Adolescent Behavior, sponsored by University of Pittsburgh. Active, not recruiting at 13 sites in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research
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 cyber-victimization. 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 suicide-related events by 50%. 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.
iCHART is an intervention that includes 3 components previously studied in within the ETUDES Center including the:
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; 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 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 iCHART in pediatric primary care will be viewed as feasible, acceptable, and appropriate by youth and caregivers across different racial and ethnic groups.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 765 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Suicide. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The criteria were revised on the registry on Nov 3, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
YOUTH
CAREGIVERS/PARENTS
Exclusion Criteria:
YOUTH
CAREGIVERS/PARENTS
iCHART is an intervention that includes 3 components previously studied in within the ETUDES Center including a: 1. Safety Planning App for suicidal youth which enables a clinician 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 clinicians 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 you to engage with the safety plan and recommended treatment following the patient visit. Participants will receive psychoeducation and referral to a mental health treatment provider, if needed.
Behavioral: iCHART
Participants in this group will receive usual care from their clinician which may will include development of a paper safety plan.
Behavioral: Treatment As Usual
The Safety Planning App will guide 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 clinicians 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 psychoeducation and referral to a mental health treatment provider, if needed.
Participants in this group will receive usual care from their clinician which may include development of a paper safety plan.
Suicide related event
Suicidal Event definition: combination of items on CSSRS + CASA: actual attempt=yes; interrupted attempt=yes; aborted attempt=yes; preparatory acts=yes; emergency referral=yes in CSSRS and include emergency referral items in CASA that are suicide related (receipt of treatment from a medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center). Note this is a composite score.
Time frame: Cumulative through 6-month follow up
Suicide related event
Suicidal Event definition: combination of items on CSSRS + CASA: actual attempt=yes; interrupted attempt=yes; aborted attempt=yes; preparatory acts=yes; emergency referral=yes in CSSRS and include emergency referral items in CASA that are suicide related (receipt of treatment from a medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center). Note this is a composite score.
Time frame: Cumulative through 12-month follow up
Depression Severity
Total scores from the Patient Health Questionnaire (PHQ-9-M) will be used to assess depression severity.
Time frame: Cumulative 6-month follow up
Time from randomization to first suicide related event
Time of onset to suicide related to event. Dates are collected on CSSRS and CASA when suicidal behavior events occur (CSSRS) and referrals are made to medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center.
Time frame: Cumulative through 6-month follow up
Time from randomization to first suicide related event
Time of onset to suicide related to event. Dates are collected on CSSRS and CASA when suicidal behavior events occur (CSSRS) and referrals are made to medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center.
Time frame: Cumulative through 12-month follow up
Frequency of suicide-related events
Number of suicide related events across sample collected from CSSRS and CASA.
Time frame: Cumulative through 6-month follow up
Frequency of suicide-related events
Number of suicide related events across sample collected from CSSRS and CASA.
Time frame: Cumulative through 12-month follow up
Aborted Attempts
Behavior section, aborted (self-interrupted) attempt endorsed for interval covered on CSSRS.
Time frame: Cumulative through 6-month follow up
Aborted Attempts
Behavior section, aborted (self-interrupted) attempt endorsed for interval covered on CSSRS.
Time frame: Cumulative through 12-month follow up
Interrupted Attempts
Behavior section, interrupted attempt endorsed for interval covered on CSSRS.
Time frame: Cumulative through 6-month follow up
Interrupted Attempts
Behavior section, interrupted attempt endorsed for interval covered on CSSRS.
Time frame: Cumulative through 12-month follow up
Actual attempt (non-fatal)
Behavior section, actual attempt endorsed for the interval covered on CSSRS.
Time frame: Cumulative through 6-month follow up
Actual attempt (non-fatal)
Behavior section, actual attempt endorsed for the interval covered on CSSRS.
Time frame: Cumulative through 12-month follow up
Preparatory acts taken for a suicide attempt
Suicidal behavior indicator endorsed for preparatory acts or behavior toward imminent suicidal behavior endorsed for the interval covered on CSSRS.
Time frame: Cumulative through 6-month follow up
Preparatory acts taken for a suicide attempt
Suicidal behavior indicator endorsed for preparatory acts or behavior toward imminent suicidal behavior endorsed for the interval covered on CSSRS.
Time frame: Cumulative through 12-month follow up
Emergency referral for increased suicidal ideation
Study emergency referral recorded in connection with increased suicidal ideation.
Time frame: Cumulative through 6-month follow up
Emergency referral for increased suicidal ideation
Study emergency referral recorded in connection with increased suicidal ideation.
Time frame: Cumulative through 12-month follow up
Emergency referral for increased suicidal ideation
Designated CASA emergency referral items where the referral is suicide related (on items related to receipt of treatment from a medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center).
Time frame: Cumulative through 6-month follow up
Emergency referral for increased suicidal ideation
Designated CASA emergency referral items where the referral is suicide related (on items related to receipt of treatment from a medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center).
Time frame: Cumulative through 12-month follow up
Service utilization
Frequency and type of concurrent psychiatric services will be measured through the Child and Adolescent Services Assessment (CASA).The CASA is a semi-structured face-to-face interview. The interview mixes close-ended questions that are often answered by "yes" or "no" with open-ended questions that allow elaboration. The CASA is comprised of four sections: The Child Health Services Screen, The Detailed Child Services Form, Attitudes Toward Services for Children and Adolescents, and Family Demographic and Financial Information (in the parent version only).
Time frame: Baseline
Service utilization
Frequency and type of concurrent psychiatric services will be measured through the Child and Adolescent Services Assessment (CASA).The CASA is a semi-structured face-to-face interview. The interview mixes close-ended questions that are often answered by "yes" or "no" with open-ended questions that allow elaboration. The CASA is comprised of four sections: The Child Health Services Screen, The Detailed Child Services Form, Attitudes Toward Services for Children and Adolescents, and Family Demographic and Financial Information (in the parent version only).
Time frame: 6-month follow up
Service utilization
Frequency and type of concurrent psychiatric services will be measured through the Child and Adolescent Services Assessment (CASA).The CASA is a semi-structured face-to-face interview. The interview mixes close-ended questions that are often answered by "yes" or "no" with open-ended questions that allow elaboration. The CASA is comprised of four sections: The Child Health Services Screen, The Detailed Child Services Form, Attitudes Toward Services for Children and Adolescents, and Family Demographic and Financial Information (in the parent version only).
Time frame: 12-month follow up
Safety planning and BRITE app use
Use of the technical components of interventions and web portals of iCHART including: the number and proportion of adolescents, parents, and providers who have engaged with the application components over time and reported pre- and post- updates to the intervention app and web portals: * Completed daily mood rating (yes/no) * Number of mood ratings * Personalized the app by adding/updating Content (yes/no) * Completed activities on the app (yes/no) * Number of completed activities * Number of logins
Time frame: Post-intervention-through 3 months (adolescents & caregivers)
Intervention Acceptability
Acceptability of the iCHART intervention will be assessed through the 4 item Acceptability of Intervention Measure (AIM). Scales can be created for by averaging responses. Scale values range from 1 to 5. Higher scores indicate greater acceptability. The items include questions to determine if intervention is appealing to, liked by, welcomed by, and approved by study population.
Time frame: Post-intervention-1 month follow up (adolescents, caregivers)
Intervention Usability
Usability of the iCHART intervention will be assessed through the Post System Satisfaction Usability Questionnaire (PSSUQ). PSSUQ follows a 7-point Likert Scale (+ NA option). The overall result is calculated by averaging the scores from the 7 points of the scale. It also has 3 sub-scales, namely system usefulness, information quality, and interface quality. The sub-scales provide a more detailed breakdown of different factors affecting the intervention. PSSUQ score starts with 1 (strongly agree) and ends with 7 (strongly disagree). The lower the score, the better the performance and satisfaction.
Time frame: Post-intervention-1 month follow up (adolescents, caregivers)
Intervention Feasibility
Feasibility of the iCHART intervention will be assessed through the 4 item Feasibility of Intervention Measure (FIM). Scales can be created for by averaging responses. Scale values range from 1 to 5. Higher scores indicate greater feasibility. The items include questions to determine if intervention is easy to use and seems possible or doable to implement in study population.
Time frame: Post-intervention-1 month follow up (adolescents, caregivers)
Intervention Appropriateness
Intervention appropriateness of the iCHART intervention will be assessed through 4 item Intervention Appropriateness Measure (IAM). Scales can be created for by averaging responses. Scale values range from 1 to 5. Higher scores indicate greater appropriateness. The items include questions to determine if intervention is a good match, fitting, suitable, or seems applicable to the study population.
Time frame: Post-intervention-1 month follow up (adolescents, caregivers)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All requests for study data will follow NIMH's data sharing and data use policies. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies, including those funded by the innovation contests. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case report forms, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. For descriptive/raw data, study investigators/study staff will upload to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis all analyzed data being uploaded prior to primary paper publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 3 months and ending 5 years following "main outcomes" article publications.
Access criteria: In addition to public access to the NDCT, proposals should be directed to georgeba2@upmc.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.
Started Jan 2023 (actual). Primary completion is estimated for Apr 2027, 51 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 51 months is above that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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