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Assessing the Impact of Mount Sinai Parenting Center's Newborn Class

8 de octubre de 2019 actualizado por: Dani Dumitriu, Icahn School of Medicine at Mount Sinai

Accessing the Effectiveness of a Pediatrician-led Newborn Parenting Class on Maternal Newborn Care Knowledge, Anxiety and Confidence

This study is the first to evaluate the effectiveness of a Newborn Parenting Class designed by Mount Sinai Parenting Center. The study measures how effective the class is in improving maternal knowledge on newborn care, decreasing maternal self-perceived anxiety and increasing maternal confidence.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

The important role positive parenting plays in promoting a child's developmental trajectory has led to the design and implementation of many postpartum education initiatives. With 99% of babies in the U.S. born in hospitals, there is a uniqueness of being in the hospital for an extended period of time with the opportunity to educate parents on the importance of promoting early development. Pediatricians are uniquely well-positioned to address both medical and developmental concerns parents may have during critical periods in a child's development, yet very few interventions are led by pediatricians. The Mount Sinai Parenting Center designed the Newborn Parent Education and Discharge Class (hereafter referred to as Newborn Class) to address this issue. The class is 1-hour long and taught be pediatric attending and residents to all families who deliver well babies at Mount Sinai. The class aims to educate parents about medical issues, responsive parenting, and sleep. It is currently taught every Tuesdays and Thursdays. Because of the limited availability of the class, not all mothers have the opportunity to attend. This research study will survey first time mothers of newborns to explore the effectiveness of attending the class. The study team hypothesizes that attending the class would result in increased knowledge on newborn care, increased confidence levels and decreased levels of anxiety.

First time mothers who delivered a full-term singleton vaginally with no major complications were included in the study. Only mothers who attended the class (intervention) or expressed desire to attend class but were discharged before a class was offered (control) were included in analysis. Mothers were recruited between May 2018 and August 2019 at the Klingenstein Pavilion of Mount Sinai. Maternal self-perceived anxiety and confidence were measured using standardized scales, and knowledge on newborn care was assessed using an internally-developed scale.

Tipo de estudio

De observación

Inscripción (Actual)

82

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 York
      • New York, New York, Estados Unidos, 10029
        • Mount Sinai Hospital

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra no probabilística

Población de estudio

Participants of the study are mothers who delivered vaginally a singleton with no major perinatal complications at Mount Sinai Hospital. Participants were not randomized into control and intervention. This was an Observational study of eligible mothers than attended the Newborn Class ("intervention group") and eligible mothers who wanted to but were not able to attend the Newborn Class because it was not available during their stay at the hospital ("control group").

Descripción

Inclusion Criteria:

  • First-time mother
  • Above 18 years old
  • Vaginal delivery of a healthy full-term singleton
  • No major perinatal complications (per self-report)
  • Consent to participate.

Exclusion Criteria:

-none

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Newborn Parenting Class
New Mother who attended the Newborn Parenting Class
Newborn Parenting Class designed by Mount Sinai Parenting Center. The class is 1-hour long and taught be pediatric attending and residents to all families who deliver well babies at Mount Sinai.
New Mothers
New Mothers who expressed interest, but did not attend the Newborn Parenting Class

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
State-Trait Anxiety Inventory for Adults (STAI)
Periodo de tiempo: Immediately after enrollment (Day 1)
Maternal self-perceived anxiety was measured using State-Trait Anxiety Inventory for Adults (State only). A 40 self-report items questionnaire, each item scored on 4-point likert-type response scale from 1 (not at all) to 4 (almost always), full range from 20 to 80, with higher score STAI scores suggesting higher levels of anxiety
Immediately after enrollment (Day 1)
Karitane Parenting Confidence Scale (KPCS)
Periodo de tiempo: Immediately after enrollment (Day 1)
Confidence level was measured using Karitane Parenting Confidence Scale. A 15 item instrument with ach item on the KPCS is scored 0, 1, 2, or 3. Total score range from 0-45, with higher score indicating the parent feeling more confident.
Immediately after enrollment (Day 1)
Newborn Care Knowledge Questionnaire
Periodo de tiempo: Immediately after enrollment (Day 1)

Knowledge on newborn care was assessed using an internally-developed scale, developed by a team of pediatricians and specialists.

Total score ranges from 0-10, with higher score indicating higher level of knowledge.

Immediately after enrollment (Day 1)

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Dani Dumitriu, MD, PhD, Columbia University Irving Medical Center; Icahn School of Medicine at Mount Sinai
  • Investigador principal: Blair S Hammond, MD, Icahn School of Medicine at Mount Sinai

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)

28 de mayo de 2018

Finalización primaria (Actual)

2 de agosto de 2019

Finalización del estudio (Actual)

2 de agosto de 2019

Fechas de registro del estudio

Enviado por primera vez

7 de octubre de 2019

Primero enviado que cumplió con los criterios de control de calidad

8 de octubre de 2019

Publicado por primera vez (Actual)

9 de octubre de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de octubre de 2019

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

8 de octubre de 2019

Última verificación

1 de octubre de 2019

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

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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