Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

29. oktober 2026 opdateret af: Stephanie Stepp, University of Pittsburgh

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

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Detaljeret beskrivelse

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;
  3. Text Messages which aims to provide texts for 2-3 weeks to motivate youth to engage with the safety plan.

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

765

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New Jersey
      • Gibbsboro, New Jersey, Forenede Stater, 08026
        • Gibbsboro
    • Pennsylvania
      • Johnstown, Pennsylvania, Forenede Stater, 15905
        • Conemaugh Memorial Medical Center-Family Medicine
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • CHOP Primary Care, CHOP Campus
      • Philadelphia, Pennsylvania, Forenede Stater, 19128
        • Roxborough
      • Philadelphia, Pennsylvania, Forenede Stater, 19139
        • CHOP Primary Care, Cobbs Creek
      • Philadelphia, Pennsylvania, Forenede Stater, 19139
        • Karabots
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • UPMC Center for Adolescent and Young Adult Health
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Children's Community Pediatrics (CCP) of Children's Hospital of Pittsburgh UPMC
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • UPMC Family Medicine
      • Pittsburgh, Pennsylvania, Forenede Stater, 15217
        • Kids Plus Pediatrics (KPP)
      • Reading, Pennsylvania, Forenede Stater, 19604
        • Berks Community Health Center
      • Springfield, Pennsylvania, Forenede Stater, 19064
        • Springfield
      • West Chester, Pennsylvania, Forenede Stater, 19380
        • CHOP Primary Care, West Chester

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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 clinician interview or report or as indicated by responses to a standardized assessments such as the PHQ-9, PHQ-9M, ASQ, CSSRS, or Behavioral Health Screen, or seeking acute care or clinical contact for mental health crisis/problem in the past year.
  • 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 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: iCHART

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.

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.

Aktiv komparator: Treatment As Usual (TAU)

Participants in this group will receive usual care from their clinician which may will include development of a paper safety plan.

Participants in this group will receive usual care from their clinician which may include development of a paper safety plan.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Suicide related event
Tidsramme: Cumulative through 6-month follow up

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.

Cumulative through 6-month follow up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Suicide related event
Tidsramme: Cumulative through 12-month follow up

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.

Cumulative through 12-month follow up
Depression Severity
Tidsramme: Cumulative 6-month follow up

Total scores from the Patient Health Questionnaire (PHQ-9-M) will be used to assess depression severity.

Cumulative 6-month follow up
Time from randomization to first suicide related event
Tidsramme: Cumulative through 6-month follow up

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.

Cumulative through 6-month follow up
Time from randomization to first suicide related event
Tidsramme: Cumulative through 12-month follow up

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.

Cumulative through 12-month follow up
Frequency of suicide-related events
Tidsramme: Cumulative through 6-month follow up

Number of suicide related events across sample collected from CSSRS and CASA.

Cumulative through 6-month follow up
Frequency of suicide-related events
Tidsramme: Cumulative through 12-month follow up

Number of suicide related events across sample collected from CSSRS and CASA.

Cumulative through 12-month follow up
Aborted Attempts
Tidsramme: Cumulative through 6-month follow up

Behavior section, aborted (self-interrupted) attempt endorsed for interval covered on CSSRS.

Cumulative through 6-month follow up
Aborted Attempts
Tidsramme: Cumulative through 12-month follow up

Behavior section, aborted (self-interrupted) attempt endorsed for interval covered on CSSRS.

Cumulative through 12-month follow up
Interrupted Attempts
Tidsramme: Cumulative through 6-month follow up

Behavior section, interrupted attempt endorsed for interval covered on CSSRS.

Cumulative through 6-month follow up
Interrupted Attempts
Tidsramme: Cumulative through 12-month follow up

Behavior section, interrupted attempt endorsed for interval covered on CSSRS.

Cumulative through 12-month follow up
Actual attempt (non-fatal)
Tidsramme: Cumulative through 6-month follow up

Behavior section, actual attempt endorsed for the interval covered on CSSRS.

Cumulative through 6-month follow up
Actual attempt (non-fatal)
Tidsramme: Cumulative through 12-month follow up

Behavior section, actual attempt endorsed for the interval covered on CSSRS.

Cumulative through 12-month follow up
Preparatory acts taken for a suicide attempt
Tidsramme: Cumulative through 6-month follow up

Suicidal behavior indicator endorsed for preparatory acts or behavior toward imminent suicidal behavior endorsed for the interval covered on CSSRS.

Cumulative through 6-month follow up
Preparatory acts taken for a suicide attempt
Tidsramme: Cumulative through 12-month follow up

Suicidal behavior indicator endorsed for preparatory acts or behavior toward imminent suicidal behavior endorsed for the interval covered on CSSRS.

Cumulative through 12-month follow up
Emergency referral for increased suicidal ideation
Tidsramme: Cumulative through 6-month follow up

Study emergency referral recorded in connection with increased suicidal ideation.

Cumulative through 6-month follow up
Emergency referral for increased suicidal ideation
Tidsramme: Cumulative through 12-month follow up

Study emergency referral recorded in connection with increased suicidal ideation.

Cumulative through 12-month follow up
Emergency referral for increased suicidal ideation
Tidsramme: Cumulative through 6-month follow up

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).

Cumulative through 6-month follow up
Emergency referral for increased suicidal ideation
Tidsramme: Cumulative through 12-month follow up

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).

Cumulative through 12-month follow up

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Service utilization
Tidsramme: Baseline

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).

Baseline
Service utilization
Tidsramme: 6-month follow up

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).

6-month follow up
Service utilization
Tidsramme: 12-month follow up

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).

12-month follow up
Safety planning and BRITE app use
Tidsramme: Post-intervention-through 3 months (adolescents & caregivers)

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
Post-intervention-through 3 months (adolescents & caregivers)
Intervention Acceptability
Tidsramme: Post-intervention-1 month follow up (adolescents, caregivers)

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.

Post-intervention-1 month follow up (adolescents, caregivers)
Intervention Usability
Tidsramme: Post-intervention-1 month follow up (adolescents, caregivers)

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.

Post-intervention-1 month follow up (adolescents, caregivers)
Intervention Feasibility
Tidsramme: Post-intervention-1 month follow up (adolescents, caregivers)

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.

Post-intervention-1 month follow up (adolescents, caregivers)
Intervention Appropriateness
Tidsramme: Post-intervention-1 month follow up (adolescents, caregivers)

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.

Post-intervention-1 month follow up (adolescents, caregivers)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Stephanie Stepp, PhD, University of Pittsburgh

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. januar 2023

Primær færdiggørelse (Anslået)

30. april 2027

Studieafslutning (Anslået)

30. april 2027

Datoer for studieregistrering

Først indsendt

8. februar 2023

Først indsendt, der opfyldte QC-kriterier

17. februar 2023

Først opslået (Faktiske)

1. marts 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • STUDY22020069
  • P50MH115838 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Beginning 3 months and ending 5 years following "main outcomes" article publications.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner