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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether iCHART, a care program for at-risk teens, can reduce suicide-related events compared with usual care. It is for teens ages 12–18 who have depression, recent thoughts of suicide, or a past suicide attempt. Teens will be placed in one of the two care groups by chance.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Teens must be ages 12–18 and speak English.
  • Teens must have current depression, thoughts of suicide in the past month, or a past suicide attempt, as measured by a study questionnaire.
  • Parents or caregivers must be at least 18, speak English, and have a child who is willing to join.
  • The participating adult must be a birth or adoptive parent, or a legal guardian with court papers allowing them to give permission for research.
  • Only one parent or caregiver takes part at a time, but another eligible parent may fill in if needed.

Who can't join

  • Teens cannot join during a manic episode (unusually high energy or mood) or a psychotic episode (trouble knowing what is real).
  • Teens cannot join if they have a life-threatening health problem that needs treatment right away.
  • Teens cannot join if an intellectual or developmental disability keeps them from understanding the study steps.
  • Teens cannot join without access to a phone or tablet needed to use parts of the program.
  • Caregivers cannot join if they are not the teen’s parent or court-appointed legal guardian.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (13)

NJ

PA