Executive Function/Metacognitive Training for At-Risk Preschoolers



Status:Completed
Conditions:Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:3 - 5
Updated:2/4/2017
Start Date:July 2012
End Date:June 2016

Use our guide to learn which trials are right for you!

The purpose of this study is to see if an intervention training executive functions like
attention, working memory, and self-regulation for preschoolers at risk for
Attention-Deficit/Hyperactivity Disorder is feasible, acceptable to families, and improves
attention, behavior, and functioning.

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.

Inclusion Criteria:

- Male or female, ages 3.0-4.11 years

- Outpatients, enrolled in a structured educational setting

- At risk for ADHD

- Parent or teacher rated BRIEF T-score > 60 on at least 1 subscale

- Not in other psychosocial interventions

- Medication free at time of the intervention

- English-speaking

Exclusion Criteria:

- Children with significant impairment will be referred for more intensive treatment.

- Pervasive developmental disorders

- Serious head injury or unstable medical or neurological conditions

- 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

- Children with an Intelligence Quotient (IQ) <85 will be excluded to avoid confounds
related to intellectual functioning
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials