Completed

ETAMExecutive Function/Metacognitive Training for At-Risk Preschoolers

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Executive Training of Attention and Metacognition (ETAM)

+ Attention Control

Behavioral
Who is being recruted

Mental Disorders+1

+ Attention Deficit and Disruptive Behavior Disorders

+ Neurodevelopmental Disorders

From 3 to 5 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorChildren's Hospital Medical Center, Cincinnati
Last updated: February 3, 2017
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorChildren's Hospital Medical Center, Cincinnati
Last updated: February 3, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

68 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Mental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersAttention Deficit Disorder with Hyperactivity

Criteria

7 inclusion criteria required to participate
At risk for ADHD

English-speaking

Male or female, ages 3.0-4.11 years

Medication free at time of the intervention

Show More Criteria

5 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group 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).

Group II

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

Study 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
CompletedOne Study Center