Promoting Maternal Mental Health and Wellbeing in Neonatal Intensive Care
26 de octubre de 2021 actualizado por: Johns Hopkins University
This small randomized pilot study will evaluate feasibility and preliminary outcomes of an audio-delivered mindfulness program to reduce psychological distress for mothers with an infant in neonatal intensive care, as compared with an active control condition.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
An estimated 400,000-480,000 infants in the U.S. with serious medical conditions are cared for in neonatal intensive care units (NICUs) each year. Maternal stress exposure related to infants' NICU stays is an under-appreciated public health problem with negative implications for maternal and child health and wellbeing. Flexible, effective intervention strategies have potential to improve maternal mental health and parenting, promoting positive emotional and behavioral outcomes for both mothers and infants.
In the investigators' successful pilot research, the investigators developed an audio-delivered mindfulness program to help NICU mothers reduce rumination and worry, cultivate a state of calm awareness, and promote self care. In this small randomized pilot study, the investigators will randomly assign mothers with an infant in the neonatal intensive care unit (NICU) to receive either the mindfulness intervention or an active control program (audio-delivered education on infant care and development).
This study will evaluate feasibility of all key research aspects, including recruitment, randomization, intervention and control conditions, and assessments, in preparation for a future larger-scale study. This study will also assess preliminary intervention outcomes to identify potential program benefits.
Tipo de estudio
Intervencionista
Inscripción (Actual)
76
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
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins University
-
-
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 a 50 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- female
- 18 to 50 years old
- mother of an infant currently being treated in the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center NICU
- able to speak English
Exclusion Criteria:
- known to have serious psychopathology
- infant medically unstable/ progress is poor
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Mindfulness Program
The intervention consists of an introductory video in which a mindfulness expert explains the program's approach and models practices to increase women's comfort with the material, four audio-recorded mindfulness practices for mothers' use when the baby is in the NICU, each available in 5- and 10-minute versions, and a brief video and four additional audio mindfulness practices (each available in briefer and longer versions) for use by mothers during and following the transition home with the baby.
|
The intervention consists of two brief videos (one introducing the NICU portion of the program and one introducing the portion of the program addressing the transition home), as well as a series of mindfulness practices delivered via audio recordings to assist mothers in managing stress during the NICU stay and another series for the transition home.
|
|
Comparador de placebos: Infant Health Education Program
The intervention consists of an introductory video explaining the program's approach, four audio recordings providing education about infant health and development, each available in 5- and 10-minute versions, and a brief video and four additional educational recordings (each available in briefer and longer versions) for use by mothers during and following the transition home with the baby.
|
The active control condition consists of two brief videos (one introducing the NICU portion of the program and one introducing the portion of the program addressing the transition home), as well as a series of audio recordings providing information on infant health and development for mothers to use during the NICU stay and another series for the transition home.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Depressive symptoms as assessed by the Patient Health Questionnaire (PHQ)-8
Periodo de tiempo: 2 weeks
|
Self-reported depressive symptoms over the last 2 weeks.
Each of the 8 items is scored 0 (not at all) to 3 (nearly every day), yielding a total between 0 and 24.
Higher scores mean more depressive symptoms.
|
2 weeks
|
|
Anxiety symptoms as assessed by the Generalized Anxiety Disorder - 7 (GAD-7)
Periodo de tiempo: 2 weeks
|
Self-reported anxiety symptoms over the last 2 weeks.
Each of the 7 items is rated from 0 (not at all) to 3 (nearly every day), yielding a total between 0 and 21.
Higher scores mean more anxiety.
|
2 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Trauma symptoms as assessed by the Stanford Acute Stress Reaction Questionnaire (SASRQ)
Periodo de tiempo: 2 weeks
|
31-item self-report measure of trauma symptoms.
Items 1-30 are rated from 0 (not experienced) to 5 (very often experienced).
Item 31 asks how many days symptoms were experienced since giving birth, ranging from no days to 5 or more days.
Higher scores mean more frequent experience of trauma symptoms.
|
2 weeks
|
|
Perceived stress as assessed by the Perceived Stress Scale - NICU (PSS-NICU)
Periodo de tiempo: Up to 2 weeks
|
Self-report measure of perceived stress related to the NICU containing 4 sub scales, each with items rated on a scale of 1 (not at all stressful) to 5 (very stressful).
Higher scores mean more stress.
|
Up to 2 weeks
|
|
Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: 4 weeks
|
Self-reported measure assessing sleep quality
|
4 weeks
|
|
Coping as assessed by the Brief Cope Scale
Periodo de tiempo: Up to 2 weeks
|
28-item self-reported measure of coping strategies.
Items are rated on a scale ranging from 1 ("I usually don't do this at all") to 4 ("I usually do this a lot")
|
Up to 2 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Erica Sibinga, M.D., Ph.D., Johns Hopkins University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 2019
Finalización primaria (Actual)
12 de octubre de 2020
Finalización del estudio (Actual)
12 de octubre de 2020
Fechas de registro del estudio
Enviado por primera vez
6 de mayo de 2019
Primero enviado que cumplió con los criterios de control de calidad
6 de mayo de 2019
Publicado por primera vez (Actual)
8 de mayo de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de octubre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
26 de octubre de 2021
Última verificación
1 de octubre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00159072
- R34AT009615 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
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. .