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A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer: A Pilot Study

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Questionnaires

+ Play Intervention

+ Questionnaires

OtroConductual
Quiénes están siendo reclutados

Neoplasias

De 4 a 10 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Cuidados de Apoyo

Controlado con PlaceboFase Temprana 1
Intervencional
Inicio del estudio: septiembre de 2011
Ver detalles del protocolo

Resumen

Patrocinador PrincipalCase Comprehensive Cancer Center
Última actualización: 3 de agosto de 2015
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de septiembre de 2011

Fecha en la que se inscribió al primer participante.

Aim 1: Assess baseline adjustment, coping, pretend play, parenting stress, and family interactions. Hypothesis 1a: Children with siblings diagnosed with cancer will have lower levels of adjustment, coping skills, and pretend play compared to previous sample norms. Hypothesis 1b: The child's adjustment will be mediated by factors related to their involvement in the sibling's medical care, such as parent's level of communication regarding their sibling's illness, frequent isolation from the family and other social support, time since their sibling's diagnosis, and parenting stress. -Hypothesis 1c: Parents of children diagnosed with cancer will report higher levels of parenting stress compared to previous sample norms. Aim 2: Assess outcome of three play intervention sessions focusing on increasing coping and adjustment. Hypothesis 2a: Compared to the active control, children in the play intervention group will have increased coping skills after intervention. Hypothesis 2b: Compared to the active control, children in the play intervention group will have better psychological adjustment following intervention. Hypothesis 2c: Parents of children in the play intervention group will report decreased parenting stress following the intervention. Once parents consent to participate and their child provides assent, they and their child will complete the baseline questionnaires and measures. Immediately following completion of the baseline measures, the child will be randomly assigned to either the play intervention or active control group.Children will also be asked to rate their mood at the beginning of each play session. The outcome parent and child questionnaires will be administered again at a session approximately one week after the third play session, for a total of four play sessions each spaced approximately one week apart. Children will also be asked to rate their satisfaction with the treatment at the outcome session (e.g., "How much did you like being a part of this study?").

Patrocinador PrincipalCase Comprehensive Cancer Center
Última actualización: 3 de agosto de 2015
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 5 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Cuidados de Apoyo

Estos estudios exploran maneras de mejorar el confort y la calidad de vida diaria de las personas que viven con una condición. Pueden centrarse en aliviar síntomas, reducir efectos secundarios del tratamiento o apoyar el bienestar general.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 4 a 10 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Neoplasias

Criterios

Inclusion Criteria: Families who have had children diagnosed with any type of cancer in the past year. At least one sibling between the ages of 4 and 10 years old Patients will be targeted 1-2 months after diagnosis, but could be included in the study up to 12 months following diagnosis. Exclusion Criteria: -

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

50% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Simulado
Children in the active control group will play with puzzles, a building toy, or color. The play facilitator will praise the child and interact at a similar rate to control for interaction with a caring adult.

Grupo II

Experimental
children in the play intervention group will be given 3 story stems that they are asked to play out with the goal of helping the main character "feel better" (see session scripts). The play facilitator will play with the child, modeling and praising use of positive coping skills. In the first session the play facilitator will focus on positive self-statements, in the second session the play facilitator will focus on problem-solving, and a combination of these two approaches will be used in the final session. The child will be allowed to make up a story about whatever they want before ending each session.

Objetivos del Estudio

Objetivos Primarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, United StatesAbrir Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center en Google Maps
Suspendido1 Centros de Estudio