A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer: A Pilot Study
Questionnaires
+ Play Intervention
+ Questionnaires
Neoplasias
Estudio de Cuidados de Apoyo
Resumen
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?").
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 5 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Cuidados de Apoyo
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.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
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.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
SimuladoGrupo II
ExperimentalObjetivos 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