Clinical trial NCT05748730: Clinical Trial for Integrated Care to Help At Risk Teen (iCHART) Intervention
Official title: The Center for Enhancing Triage and Utilization for Depression and Emergent Suicidality (ETUDES) in Pediatric Primary Care-iCHART RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide and Depression
Adolescent Behavior
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: University of Oregon
name: Columbia University
name: Kaiser Permanente
name: National Institute of Mental Health (NIMH)
First posted: 2023-03-01
Enrollment: 900
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses an effectiveness-implementation hybrid type 1 randomized clinical trial (RCT) design.

A qualitative, descriptive design will be used to analyze qualitative aims of this study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Depression Severity
timeFrame: Baseline
measure: Depression Severity
timeFrame: 1 Month Follow Up
measure: Depression Severity
timeFrame: 3 Month Follow Up
measure: Depression Severity
timeFrame: 6 Month Follow Up
measure: Depression Severity
timeFrame: 12 Month Follow Up
measure: Suicidal Ideation and Behavior
timeFrame: Baseline
measure: Suicidal Ideation and Behavior
timeFrame: 1 month follow up
measure: Suicidal Ideation and Behavior
timeFrame: 3 month follow up
measure: Suicidal Ideation and Behavior
timeFrame: 6 month follow up
measure: Suicidal Ideation and Behavior
timeFrame: 12 month follow up
Secondary outcomes:
measure: Service Utilization
timeFrame: Baseline
measure: Service Utilization
timeFrame: 6 month follow up
measure: Service Utilization
timeFrame: 12 month follow up
measure: Application Utilization
timeFrame: Post-intervention-6 month follow up
measure: Intervention Acceptability (intervention liked by study population)
timeFrame: Post-intervention-6 month follow up
measure: Intervention Usability
timeFrame: Post-intervention-6 month follow up
measure: Intervention Feasibility (intervention is implementable in study population)
timeFrame: Post-intervention-6 month follow up
measure: Intervention Appropriateness (intervention fits or matches study population needs)
timeFrame: Post-intervention-6 month follow up
Other outcomes:
Locations:
city: McMurray
country: United States
facility: Children's Community Pediatrics (CCP- Waterdam) of Children's Hospital of Pittsburgh UPMC
state: Pennsylvania
city: Philadelphia
country: United States
facility: CHOP Primary Care, CHOP Campus
state: Pennsylvania
city: Philadelphia
country: United States
facility: CHOP Primary Care, Cobbs Creek
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Center for Adolescent and Young Adult Health
state: Pennsylvania
city: West Chester
country: United States
facility: CHOP Primary Care, West Chester
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Stephanie Stepp, PhD
role: PRINCIPAL_INVESTIGATOR
References: