- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02459873
Modeling and Testing Change in Mental Abilities in Childhood
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
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90089
- University of Southern California
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Understands and speaks English
Exclusion Criteria:
- Diagnosed psychological disorder
- Head trauma with loss of consciousness of >5 minutes
Plan de estudios
¿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 |
|---|---|
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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.
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Children get access to computer games for 10 weeks for an hour each week.
Otros nombres:
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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.
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Children get access to computer games for 10 weeks for an hour each week.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in working memory skills assessed through Executive Function Battery and NIH ToolBox
Periodo de tiempo: 3 months
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Children will be assessed both on Executive Function Battery and the NIH Toolbox battery to examine change in working memory skills.
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3 months
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Change in processing speed skills assessed through Executive Function Battery and NIH ToolBox
Periodo de tiempo: 3 months
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Children will be assessed both on Executive Function Battery and the NIH Toolbox battery to examine change in processing speed skills.
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3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in school grades in science, reading and math.
Periodo de tiempo: 3-6 months
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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
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3-6 months
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Change in parent reported behavior as assessed through BRIEF and CBCL questionnaires
Periodo de tiempo: 3-6 months
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Parental reports on BRIEF (Behavior Rating Inventory of Executive Function) and CBCL (Child Behavior Checklist) questionnaires will be used to assess change in behavior
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3-6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Prapti Gautam, PhD, University of Southern California
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 15-01767
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