ETAMExecutive Function/Metacognitive Training for At-Risk Preschoolers
Executive Training of Attention and Metacognition (ETAM)
+ Attention Control
Mental Disorders+1
+ Attention Deficit and Disruptive Behavior Disorders
+ Neurodevelopmental Disorders
Prevention Study
Summary
Study start date: July 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.68 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 3 to 5 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Cincinnati Children's Hospital Medical Center
Cincinnati, United StatesOpen Cincinnati Children's Hospital Medical Center in Google Maps