Attention Deficit Hyperactivity DisorderETAMNCT01675869
Executive Function/Metacognitive Training for At-Risk Preschoolers
A study testing Executive Training of Attention and Metacognition (ETAM) in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Executive Training of Attention and Metacognition (ETAM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Executive Training of Attention and Metacognition (ETAM), Attention Control
- Keywords
- Attention-Deficit/Hyperactivity Disorder, Executive function, Preschooler, Metacognition
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Executive Training of Attention and Metacognition (ETAM)Behavioural
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).
Attention ControlBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| ETAM group | 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). Receives: Behavioral: Executive Training of Attention and Metacognition (ETAM) |
| Attention Control | Active comparator | Attention control group: An 8-week program which provides education regarding several topics relevant for preschool children including nutrition, sleep, temperament, etc. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leanne Tamm, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675869
- Sponsor's protocol ID
- R34MH095911
- Acronym
- ETAM
- Status last verified
- Feb 2017
- First submitted
- 10 Jul 2012
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28107027
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Function/Metacognitive Training for At-Risk Preschoolers
- ClinicalTrials.gov ID
- NCT01675869
- Acronym / sponsor ID
- ETAM / R34MH095911
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention-Deficit/Hyperactivity Disorder, Executive function, Preschooler, Metacognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETAM group | Experimental | Behavioral: Executive Training of Attention and Metacognition (ETAM)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 | Active comparator | Behavioral: Attention ControlAttention control group: An 8-week program which provides education regarding several topics relevant for preschool children including nutrition, sleep, temperament, etc. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Executive Training of Attention and Metacognition (ETAM)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). | Behavioural | ETAM group |
| Attention ControlAttention 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). | Behavioural | Attention Control |
Primary outcome
Executive Functioning
Time frame: 2 month follow-up
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Results publication: PubMed 28107027Tamm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leanne Tamm, Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Executive Training of Attention and Metacognition (ETAM) in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive Functioning (time frame: 2 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01675869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.