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Executive Function/Metacognitive Training for At-Risk Preschoolers (ETAM)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Executive Training of Attention and Metacognition (ETAM)
Attention Control
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention-Deficit/Hyperactivity Disorder, Executive function, Preschooler, Metacognition

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ETAM group

Attention Control

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Executive Functioning
Investigators will compute an aggregated measure of EF deficits. For each EF measure investigators will define a threshold for adequate performance as a score obtained by 75% of the children. Performance will be dummy-coded according to this threshold as "0" for adequate performance and "1" for poor performance. We will then calculate a continuous measure of EF ranging from 0 (adequate performance on all) to 9 (poor performance on all), by summing the dummy coded scores of all EF measures.

Secondary Outcome Measures

Full Information

First Posted
July 10, 2012
Last Updated
February 2, 2017
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT01675869
Brief Title
Executive Function/Metacognitive Training for At-Risk Preschoolers
Acronym
ETAM
Official Title
Executive Function/Metacognitive Training for At-Risk Preschoolers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention-Deficit/Hyperactivity Disorder, Executive function, Preschooler, Metacognition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ETAM group
Arm Type
Experimental
Arm Description
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).
Arm Title
Attention Control
Arm Type
Active Comparator
Arm Description
Attention control group: An 8-week program which provides education regarding several topics relevant for preschool children including nutrition, sleep, temperament, etc.
Intervention Type
Behavioral
Intervention Name(s)
Executive Training of Attention and Metacognition (ETAM)
Intervention Description
ETAM is an 8-week intervention involving weekly concurrent child (n=~6 per group) and parent intervention groups. The ETAM groups will be 1 hour in length (except for the first session which will be 2 hours).
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Intervention Description
Attention Control is an 8-week intervention involving weekly concurrent child (n=~6 per group) and parent groups that control for the effects of attention. The groups will be 1 hour in length (except for the first session which will be 2 hours).
Primary Outcome Measure Information:
Title
Executive Functioning
Description
Investigators will compute an aggregated measure of EF deficits. For each EF measure investigators will define a threshold for adequate performance as a score obtained by 75% of the children. Performance will be dummy-coded according to this threshold as "0" for adequate performance and "1" for poor performance. We will then calculate a continuous measure of EF ranging from 0 (adequate performance on all) to 9 (poor performance on all), by summing the dummy coded scores of all EF measures.
Time Frame
2 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leanne Tamm, Ph.D.
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28107027
Citation
Tamm L, Epstein JN, Loren REA, Becker SP, Brenner SB, Bamberger ME, Peugh J, Halperin JM. Generating Attention, Inhibition, and Memory: A Pilot Randomized Trial for Preschoolers With Executive Functioning Deficits. J Clin Child Adolesc Psychol. 2019;48(sup1):S131-S145. doi: 10.1080/15374416.2016.1266645. Epub 2017 Jan 20.
Results Reference
result

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Executive Function/Metacognitive Training for At-Risk Preschoolers

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