- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03303482
A Randomized Controlled Trial of Trauma-awareness Training for Early Childhood Educators
Background. To increase school readiness, Pre-K programs for low-income children must be responsive to the role of trauma in the lives of children, families, and staff. In 2017-2018, the School District of Philadelphia's (SDP) Office of Early Childhood Education will help Pre-K teachers support children's social-emotional and behavioral health, which is essential for early learning, by offering teachers a professional development course called Enhancing Trauma Awareness (ETA).
Purpose. To determine whether teachers who take ETA will have: 1) better work functioning; 2) more trusting work relationships; and 3) better health.
Population. Pre-K classroom teachers (n=128) working in centers under SDP auspice that serve exclusively low-income (≤300 % of poverty) children.
Intervention. A 12-week professional development course-Enhancing Trauma Awareness-will delivered by Lakeside Global Institute in 6 group sessions, with 16 teachers per group and each session lasting 2.5 hours.
Design. Consenting teachers will be randomly assigned by classroom (lead teacher and/or assistant teacher) to receive the ETA course in either fall 2017 (intervention groups) or spring 2018 (wait-list control groups).
Data collection and analysis. An external evaluation team (Temple University) will administer a confidential, online survey to all 128 teachers in fall 2017 (before fall course), winter 2017 (after fall course), and spring 2018 (after spring course). Teacher-children relationship quality will be the a priori primary outcome, and secondary outcomes will be assessed across the domains of work functioning, trust, and health.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 01940
- Temple University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Grupo de Intervención
|
The trauma awareness professional development course is delivered in a small group (up to 16 participants; 2.5 hours every other week over 12 weeks).
The course provides an environment for professionals to explore in depth the complex nature of trauma, while also recognizing and emphasizing the highly sensitive nature of trauma that is essential to becoming trauma-informed.
The course facilitates a heightened awareness and appreciation for trauma-related behaviors and consequences that influence relationships and systems and that persist across generations.
|
Sin intervención: Grupo de control de lista de espera
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in teacher-children relationship quality (specifically, levels of perceived conflict) at 3 months
Periodo de tiempo: The teacher-children relationship quality measurement will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
A modified version of the Student-Teacher Relationship Scale (STRS) conflict subscale will be used to allow each teacher to provide one global or aggregated assessment of her/his relationships with all the children in the classroom.
The conflict subscale includes eight items to assess negative, insecure, and hostile aspects of relationships.
|
The teacher-children relationship quality measurement will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in mindfulness (Cognitive and Affective Mindfulness Scale-Revised) at 3 months
Periodo de tiempo: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
Change in empathy (Interpersonal Reactivity Index) at 3 months
Periodo de tiempo: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
Change in emotion regulation (Emotion Regulation Questionnaire) at 3 months
Periodo de tiempo: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
Change in compassion satisfaction (Professional Quality of Life Scale) at 3 months
Periodo de tiempo: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
Change in job satisfaction (adapted from Gallup Well-Being Work Index) at 3 months
Periodo de tiempo: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
Change in attitudes about trauma-informed care (Attitudes Related to Trauma-Informed Care Scale) at 3 months
Periodo de tiempo: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
Change in burnout (Maslach Burnout Inventory General) at 3 months
Periodo de tiempo: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
Change in trust in relationships with parents, supervisors, and other staff members (adapted from Trust in Schools Instruments) at 3 months
Periodo de tiempo: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
Change in mentally and physically unhealthy days (CDC Health-Related Quality of Life Healthy Days Core Module) at 3 months
Periodo de tiempo: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
Change in quality and duration of nighttime sleep (Pittsburgh Sleep Quality Index) at 3 months
Periodo de tiempo: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Robert Whitaker, MD, MPH, Temple University
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UW17246
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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 Agotamiento, Profesional
-
University of ArizonaAún no reclutandoMindfulness, Burnout, Ansiedad, Sueño
-
Mayo ClinicNational Institute of Nursing Research (NINR)Inscripción por invitación
-
Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)TerminadoEficacia y Tolerancia de B-Back® en el Síndrome de BurnoutFrancia
-
David Grant U.S. Air Force Medical CenterTerminadoBurnout entre médicos residentes de medicina familiarEstados Unidos
-
Gerencia de Atención Primaria, MadridFondo de Investigacion SanitariaTerminado
-
Federal University of São PauloFederal University of Rio Grande do SulTerminado
-
Dr. Ersin Arslan Education and Training HospitalDesconocidoSíndrome de burnoutPavo
-
Göteborg UniversityDesconocido
-
Nazarbayev University Medical CenterUniversity of South Florida; Università degli Studi dell'InsubriaAún no reclutando
-
University of California, San FranciscoTerminadoEstrés | Cirugía | Síndrome de burnoutEstados Unidos