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Modeling and Testing Change in Mental Abilities in Childhood

14 de abril de 2017 actualizado por: University of Southern California

Modeling and Testing Change in Mental Abilities in Childhood Through Computer-based Interventions

Children with low executive function, working memory and attention skills in childhood not only do poorly at school, but also go on to do poorly on social, health, and financial indicators in adulthood.

The rate of executive function disorders in children is vastly underestimated at 17% , even when taking into account two of the more widely known disorders of Attention Deficit Hyperactivity Disorder (11%) and Fetal Alcohol Spectrum Disorders (6%), but children of lower socioeconomic status are especially vulnerable due to reduced resource availability.

As executive function, working memory and attention skills are central to success in later life, if children with low skills can be given targeted training to improve the skills they fall short on, there is potential to both improve their short-term academic performance, and influence long-term achievement. In fact, poor executive function skills and poor attention and working memory is a large predictor of poor performance even in typically developing children who are doing poorly academically.

Hypothesis 1. Those with lower working memory will also have lower problem solving skills and lower indices of other executive functioning skills such as reasoning/problem solving.

Hypothesis 2. Children that start with lower WM and PS will show the highest gains in training related performance, and such high gains on WM and PS will lead to better performance post-intervention compared to baseline measures of cognitive function.

Hypothesis 3: Those who make the largest gains in WM and PS with training will show more retention of training gains at 6 months compared those who show lower gains.

Aim 1. Assess working memory (WM) and processing speed (PS) skills in children and their inter-relationships with executive functioning skills Aim 2. Examine change in cognitive function in WM and PS after intensive training in WM and PS, during and immediately post-intervention Aim 3. Examine long-term retention of training effects on WM, PS, and executive functions.

The purpose of this study is to establish an effective and targeted working memory and processing speed intervention in children ages 7-10 with low to average executive function skills, by utilizing home-based computer games specifically designed to appeal to children.

Following institution approved consents, 60 low socioeconomic status children from Los Angeles will be recruited and enrolled in the study and be asked to play specific fun, but targeted cognitive computer games for 10 weeks.

The results of this pilot study will establish a protocol for feasibility of improving executive function skills in children with underdeveloped skills and inform on sufficiency of sample sizes, length of interventions, and directly impact computer-based intervention research and cost-effective techniques in children's cognitive development within the next 3-5 years.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

20

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

    • California
      • Los Angeles, California, Estados Unidos, 90089
        • University of Southern California

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

7 años a 11 años (Niño)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Understands and speaks English

Exclusion Criteria:

  • Diagnosed psychological disorder
  • Head trauma with loss of consciousness of >5 minutes

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: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Computer games to assess change in executive function skills
Children in Intervention group get to train using executive function games at more difficult levels.
Children get access to computer games for 10 weeks for an hour each week.
Otros nombres:
  • Difficult / Easy games
Comparador activo: Easy games as active comparators for executive function skills
Children in Non-intervention group get to play executive function games at an easy level.
Children get access to computer games for 10 weeks for an hour each week.
Otros nombres:
  • Difficult / Easy games

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in working memory skills assessed through Executive Function Battery and NIH ToolBox
Periodo de tiempo: 3 months
Children will be assessed both on Executive Function Battery and the NIH Toolbox battery to examine change in working memory skills.
3 months
Change in processing speed skills assessed through Executive Function Battery and NIH ToolBox
Periodo de tiempo: 3 months
Children will be assessed both on Executive Function Battery and the NIH Toolbox battery to examine change in processing speed skills.
3 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in school grades in science, reading and math.
Periodo de tiempo: 3-6 months
Parents will be asked for children's school grades at the beginning of the study, during the study, and at the end of the study to assess the effects of the intervention
3-6 months
Change in parent reported behavior as assessed through BRIEF and CBCL questionnaires
Periodo de tiempo: 3-6 months
Parental reports on BRIEF (Behavior Rating Inventory of Executive Function) and CBCL (Child Behavior Checklist) questionnaires will be used to assess change in behavior
3-6 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Prapti Gautam, PhD, University of Southern California

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

1 de junio de 2015

Finalización primaria (Actual)

31 de agosto de 2016

Finalización del estudio (Actual)

31 de agosto de 2016

Fechas de registro del estudio

Enviado por primera vez

27 de mayo de 2015

Primero enviado que cumplió con los criterios de control de calidad

1 de junio de 2015

Publicado por primera vez (Estimar)

2 de junio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de abril de 2017

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

14 de abril de 2017

Última verificación

1 de abril de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 15-01767

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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