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ETAMExecutive Function/Metacognitive Training for At-Risk Preschoolers

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Qué se está evaluando

Executive Training of Attention and Metacognition (ETAM)

+ Attention Control

Conductual
Quiénes están siendo reclutados

Trastornos Mentales

+ Trastorno por Déficit de Atención con Hiperactividad

De 3 a 5 años
+12 Criterios de eligibilidad
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Cómo está diseñado el estudio

Estudio de Prevención

Intervencional
Inicio del estudio: julio de 2012
Ver detalles del protocolo

Resumen

Patrocinador PrincipalChildren's Hospital Medical Center, Cincinnati
Última actualización: 3 de febrero de 2017
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de julio de 2012

Fecha en la que se inscribió al primer participante.

Disruptive behavior disorders, particularly Attention-Deficit/Hyperactivity Disorder (ADHD), constitute one of the most common diagnoses in preschool children. Disruptive behaviors are a major public health problem including causing significant emotional distress for caregivers and children, expulsion from daycare or early education settings, demands on caregiver's time, accident proneness and other safety concerns. However, few evidence-based early interventions exist for preschoolers with attention and behavior problems, which is critical because they are strongly suggested as the first line of treatment for preschoolers with ADHD. Because executive functioning (EF) has been consistently been proposed as a putative factor in the development of disruptive behavior disorders an intervention targeting EF (e.g., inhibition, working memory), attention, and metacognition during early childhood could likely affect the development of disruptive behavior disorders in preschoolers. Indeed, EF skills are identified by kindergarten teachers as primary prerequisites for school success. EF deficits independently contribute to poorer outcomes in ADHD, and have been linked directly to academic and social functioning deficits. Given that EF and brain development are rapidly developing during the preschool years, preschoolers may benefit most from an early intervention targeting EF skills. Investigators have developed a promising intervention, Executive Training of Attention and Metacognition (ETAM), for preschoolers, and have conducted a small preliminary open trial demonstrating the initial acceptability of the intervention. Investigators also found significant moderate effect sizes on objective measures of EF and moderate to large effect size reductions in ratings of inattention and behavioral symptoms by parents, clinicians, and teachers. A randomized clinical trial (RCT) is needed to investigate if these positive effects on executive functioning, attention, and behavior are due to ETAM or to the effect of parental attention and/or a placebo effect. Investigators propose to assess the feasibility of a design for a future RCT. Investigators will develop an attention control (AC) comparison group and assess the feasibility of: identifying, enrolling and retaining preschoolers at-risk for ADHD, randomization choices, the measurement of EF and functional outcomes, and delivery protocol for both AC and ETAM by conducting a pilot RCT with 60 children at-risk for ADHD. Exploratory aims include assessing whether children in the ETAM group show gains compared to those in AC on targeted (trained) outcomes (i.e., measures of EF) and untrained outcomes (i.e., ADHD symptoms, academic readiness, social competence). Investigators will also assess whether gains are maintained as well as investigate potential moderators/mediators.

Patrocinador PrincipalChildren's Hospital Medical Center, Cincinnati
Última actualización: 3 de febrero de 2017
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 68 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Prevención

Los estudios de prevención buscan evitar que se desarrolle una enfermedad. A menudo incluyen a personas en riesgo y evalúan vacunas, cambios en el estilo de vida o medicamentos preventivos.



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 3 a 5 años

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

Voluntarios sanos no permitidos

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

Condiciones

Patología

Trastornos MentalesTrastorno por Déficit de Atención con Hiperactividad

Criterios

7 criterios de inclusión requeridos para participar
At risk for ADHD

English-speaking

Male or female, ages 3.0-4.11 years

Medication free at time of the intervention

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5 criterios de exclusión impiden participar
Children with an Intelligence Quotient (IQ) < 85 will be excluded to avoid confounds related to intellectual functioning

Children with significant impairment will be referred for more intensive treatment

Judged by one of the investigators to be acutely suicidal or homicidal, or at imminent risk of injuring self or others or causing significant damage to property

Pervasive developmental disorders

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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

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Executive Function/Metacognitive Training Program: An 8-week program, which addresses major areas of deficit in ADHD; namely, attention (the ability to concentrate and focus), inhibition (the ability to control ones behaviors), and memory (the ability to remember information).

Grupo II

Comparador Activo
Attention control group: An 8-week program which provides education regarding several topics relevant for preschool children including nutrition, sleep, temperament, etc.

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

Cincinnati Children's Hospital Medical Center

Cincinnati, United StatesAbrir Cincinnati Children's Hospital Medical Center en Google Maps
Completado1 Centros de Estudio