- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05041517
Brief Online Training (BOLT) for Routine Outcome Monitoring
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
In the US, although roughly one in five children experiences a mental health problem severe enough to warrant diagnosis and intervention, most lack access to needed services. Schools offer opportunities to improve service access, but school mental health clinicians are unlikely to deliver high-quality evidence-based practices (EBP). Multiple barriers interfere with clinicians receiving adequate training and support for EBP, including limited time and scarce training resources. The goal of this project is to improve school-based services by developing and testing an online training and consultation system to facilitate the use of measurement-based care (MBC). MBC is the target intervention because it is an EBP with extensive empirical support for its ability to improve mental health service outcomes and is a feasible and cost-effective option.
The larger study was conducted in phases to address study aims (this clinical trial record reflects Aim 3/Phase 5):
- AIM 1: Phases 1 and 2. Develop the Brief On-Line Training (BOLT) for Measurement-Based Care training through prototyping and continuous user testing. The goal is to optimize BOLT's impact on system usability and clinician gains in MBC knowledge and attitudes.
- AIM 2: Phases 3 and 4. Develop the BOLT post-training consultation procedures to optimize effective consultation.
- AIM 3: Phase 5. Test BOLT by conducting a randomized controlled pilot trial of the full BOLT training/consultation package to test (1) its impact on MBC knowledge, attitudes, and use; (2) the impact of varying degrees of consultation dosage on weekly assessments of MBC use; and (3) moderators and mechanisms of impact: (a) system usability, (b) clinician knowledge and attitudes gain, (c) experience of collaboration, and (d) responsiveness of consultation.
During the final year (i.e., phase 5), participants include a sample of 75 clinicians, recruited from national email listservs in order to most closely approximate how clinicians tend to discover and engage in online training opportunities. Participants complete an initial online survey about their use of MBC in practice and are randomly assigned to participate in one of two study conditions: the BOLT condition (training and consultation) or a Control condition (no training and no consultation). Participants in the BOLT condition complete a self-paced Brief Online Training (BOLT) for Measurement-Based Care (MBC), are asked to begin to use MBC with their caseloads, and are then randomly assigned to one of three different consultation groups receiving 2 weeks, 4 weeks or 8 weeks of consultation. Participation in a consultation group includes participating in biweekly group phone consultations and posting weekly assignments on an online consultation discussion board about their use of MBC in practice. Participants in all BOLT groups and the Control condition complete weekly online surveys for the full 32 weeks of data collection.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98115
- University of Washington
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Between 22-80 years of age
- Employed as a School-Based Mental Health provider
- Must routinely provide individual-level interventions or therapy to students and spend >50% of their time providing services in schools
Exclusion Criteria:
- Being younger than 22 or older than 80
- Not being employed as a School-Based Mental Health provider
- Don't provide individual-level interventions or therapy to students nor spend >50% of their time providing services in schools.
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control
Sin intervención
|
|
|
Experimental: BOLT + 1 PTC
BOLT Training + 1 PTC Call
|
BOLT is a Brief Online Training (BOLT) for Measurement-Based Care (MBC).
Participants in the BOLT condition were subsequently randomized into varying amounts of post-training consultation (PTC).
|
|
Experimental: BOLT + 2 PTC
BOLT Training + 2 PTC Calls
|
BOLT is a Brief Online Training (BOLT) for Measurement-Based Care (MBC).
Participants in the BOLT condition were subsequently randomized into varying amounts of post-training consultation (PTC).
|
|
Experimental: BOLT + 4 PTC
BOLT Training + 4 PTC Calls
|
BOLT is a Brief Online Training (BOLT) for Measurement-Based Care (MBC).
Participants in the BOLT condition were subsequently randomized into varying amounts of post-training consultation (PTC).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Current Assessment Practice Evaluation - Revised (CAPER) - Change of use of MBC
Periodo de tiempo: Baseline, Weeks 2-32
|
The CAPER includes the original four-item CAPE measure plus three new items to assess use of individualized assessment.
It assesses clinician self-reported use of the full range of MBC practices including administration of individualized/standardized assessments at different points during treatment, client feedback on assessment results, and using assessment results to inform treatment.
All items are scored on a 1-4 scale, with anchors signifying percent of clients they used the practice with: 1 = None (0%), 2 = Some (1-39%), 3 = Half (40-60%), 4 = Most (61-100%).
|
Baseline, Weeks 2-32
|
|
Monitoring & Feedback Attitudes Scale (MFAS) - Change of attitudes about MBC use
Periodo de tiempo: Baseline, Weeks: 2,4,6,8,10,16,20,24,28,32
|
The purpose of this measure is to collect information on attitudes on routine progress monitoring (or measurement-based care).
Monitoring and Feedback Attitudes Scale (MFA; Jensen-Doss, Becker, Smith, Lyon, Lewis, Stanick, & Hawley, 2018) responses range from 1 ("Strongly Disagree") to 5 ("Strongly Agree").
The MFA has two subscales: (1) Benefit (i.e., facilitating collaboration with clients) and (2) Harm (i.e., harmful for therapeutic alliance, misuse by administrators).
|
Baseline, Weeks: 2,4,6,8,10,16,20,24,28,32
|
|
MBC Knowledge Questionnaire (MBCKQ) - Change of knowledge about MBC
Periodo de tiempo: Baseline, Weeks: 2,4,6,8,10,16,20,24,28,32
|
The purpose of this questionnaire is to measure MBC knowledge.
The 28-item, multiple-choice MBCKQ was iteratively developed based on the key content and learning objectives of the MBC training modules.
|
Baseline, Weeks: 2,4,6,8,10,16,20,24,28,32
|
|
Routine-Outcome Monitoring Skill - Change of skill of MBC use
Periodo de tiempo: Baseline, Weeks: 2,4,6,8,10,16,20,24,28,32
|
The purpose of this measure is to collect information on clinician familiarity and use of routine outcome monitoring (both individualized and standardized assessment tools).
Items address selection of clients for administration as well as tool selection, administration, scoring, interpretation, integration into treatment, feedback, and progress monitoring.
In previous samples, the scale had good internal consistency (Cronbach's α = .85).
Responses are ratings about skill level and practice, ranging from 1 (''Minimal'') to 5 (''Advanced'').
Items are averaged to create a total assessment skill score.
|
Baseline, Weeks: 2,4,6,8,10,16,20,24,28,32
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- 52550
- R34MH109605 (Subvención/contrato del NIH de EE. UU.)
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. .
Ensayos clínicos sobre Problema de salud mental
-
University of Dublin, Trinity CollegeDesconocidoAtletas de élite retirados de Brain Health
-
Queens College, The City University of New YorkReclutamientoPublicación de artículos enviados al American Journal of Public HealthEstados Unidos
-
WestatPlasma Protein Therapeutics AssociationAún no reclutandoHealth Effects (Niveles de Ferritina, Niveles de PCR, Niveles de IgG, Salud Auto-reportada)Estados Unidos
-
Neslihan LokTerminadoAdolescente | Salud mental | Cuidado de la salud mental | Condiciones de salud mentalPavo
-
Chinese University of Hong KongReclutamientoSalud Mental Bienestar 1 | Bienestar mental | Problema de salud mental | Salud mental de precisiónHong Kong
-
Sword Health, SAInscripción por invitaciónResiliencia mental | Angustia mentalEstados Unidos
-
Sanctuary Mental Health MinistriesExcellence in Giving InsightsAún no reclutandoSalud mental | Búsqueda de ayuda de salud mental | Alfabetización en salud mentalEstados Unidos
-
Chinese University of Hong KongTerminadoBienestar mental | Alfabetización en salud mentalHong Kong
-
King's College LondonTerminadoSalud Mental Bienestar 1 | Problema de salud mentalReino Unido
-
Chinese University of Hong KongTerminadoSalud Mental Bienestar 1 | Bienestar mental | Problema de salud mentalHong Kong
Ensayos clínicos sobre BOLT + PTC
-
University of UtahInscripción por invitación
-
Rigshospitalet, DenmarkTerminado
-
Beijing Tsinghua Chang Gung HospitalBeijing Shijitan Hospital, Capital Medical University; Cangzhou Central Hospital y otros colaboradoresReclutamiento
-
Peking UniversityAún no reclutandoNeoplasias Gastrointestinales
-
University of California, IrvineNational Cancer Institute (NCI)TerminadoCáncer de cuello uterino | Efectos psicosociales del cáncer y su tratamientoEstados Unidos
-
Aristotle University Of ThessalonikiNational and Kapodistrian University of Athens; University of Ulm; Greek Alzheimer...TerminadoSaludable | Defecto cognitivo leve | Demencia leve
-
Rigshospitalet, DenmarkTerminadoCáncer de páncreas | Fístula biliar | Cirugía-ComplicacionesDinamarca
-
Aristotle University Of ThessalonikiGreek Alzheimer's Association and Related DisordersTerminadoSaludable | Deterioro cognitivo leve, así dicho | Demencia leve
-
Edison Pharmaceuticals IncTerminadoEnfermedad de ParkinsonEstados Unidos, Alemania, Reino Unido
-
Shengjing HospitalTerminadoEndoscopia, Sistema Digestivo | Hepatolitiasis