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

29 de octubre de 2026 actualizado por: Stephanie Stepp, University of Pittsburgh

El Centro para Mejorar el Triaje y la Utilización para la Depresión y el Suicidio Emergente (ETUDES) en Atención Primaria Pediátrica-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.

Descripción general del estudio

Estado

Activo, no reclutando

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

765

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

Comparador activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Suicide related event
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Suicide related event
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Cumulative through 6-month follow up

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

Cumulative through 6-month follow up
Interrupted Attempts
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Service utilization
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Stephanie Stepp, PhD, University of Pittsburgh

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

26 de enero de 2023

Finalización primaria (Estimado)

30 de abril de 2027

Finalización del estudio (Estimado)

30 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

8 de febrero de 2023

Primero enviado que cumplió con los criterios de control de calidad

17 de febrero de 2023

Publicado por primera vez (Actual)

1 de marzo de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • STUDY22020069
  • P50MH115838 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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