- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05748730
Clinical Trial for Integrated Care to Help At Risk Teens (iCHART) Intervention
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
Condiciones
Intervención / Tratamiento
Descripción detallada
iCHART is an intervention that includes 3 components previously studied in within the ETUDES Center including the:
- 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);
- Mental Health Screener questionnaire that gathers additional mental health symptoms, treatment preferences, and family's readiness for treatment engagement;
- 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
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New Jersey
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Gibbsboro, New Jersey, Estados Unidos, 08026
- Gibbsboro
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Pennsylvania
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Johnstown, Pennsylvania, Estados Unidos, 15905
- Conemaugh Memorial Medical Center-Family Medicine
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- CHOP Primary Care, CHOP Campus
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Philadelphia, Pennsylvania, Estados Unidos, 19128
- Roxborough
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Philadelphia, Pennsylvania, Estados Unidos, 19139
- CHOP Primary Care, Cobbs Creek
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Philadelphia, Pennsylvania, Estados Unidos, 19139
- Karabots
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- UPMC Center for Adolescent and Young Adult Health
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Children's Community Pediatrics (CCP) of Children's Hospital of Pittsburgh UPMC
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- UPMC Family Medicine
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Pittsburgh, Pennsylvania, Estados Unidos, 15217
- Kids Plus Pediatrics (KPP)
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Reading, Pennsylvania, Estados Unidos, 19604
- Berks Community Health Center
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Springfield, Pennsylvania, Estados Unidos, 19064
- Springfield
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West Chester, Pennsylvania, Estados Unidos, 19380
- CHOP Primary Care, West Chester
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
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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.
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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:
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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.
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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
¿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:
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. |
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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
|
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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
|
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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
|
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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
|
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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
|
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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:
|
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)
|
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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
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Stephanie Stepp, PhD, University of Pittsburgh
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
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)?
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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .