Central Executive Training (CET) for ADHD

March 5, 2025 updated by: Michael J. Kofler, Florida State University

Central Executive Training for ADHD: Efficacy Trial

The goal of the current project is to assess the efficacy of Central Executive Training (CET) for youth with ADHD. CET is a new, computerized training intervention that targets specific components of the working memory system. Two versions of CET were developed as part of our R34, each targeting a different combinations of executive functions. The final CET protocol reflects the contributions and feedback of a diverse group of caregivers, children with ADHD, and recognized experts in human cognition, ADHD treatment research, randomized control trial (RCT) intervention design methods, serious game theory and task design, cognitive training, and the role of executive dysfunction in ADHD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
251

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Michael Kofler, PhD
  • Phone Number: 850-645-7423
  • Email: clc@psy.fsu.edu

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32306
        • Florida State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children ages 8-12 with principal ADHD diagnoses (via Kiddie Schedule for Affective Disorders semi-structured clinical interviewing (K-SADS)
  • Parent AND teacher ratings in clinical/borderline range based on age and gender on ADHD-RS-5 or BASC-3 Attention Problems/Hyperactivity subscales
  • Below average or lower working memory on at least one pre-treatment WM test. All ADHD presentations will be eligible.

Exclusion Criteria:

  • gross neurological, sensory, or motor impairment
  • history of seizure disorder, psychosis, bipolar, or severe dysregulation disorders that may interfere with study participation (substance use, disruptive mood dysregulation, intermittent explosive, reactive attachment)
  • intellectual disability or Wechsler Intelligence Scale for Children (WISC-V) short-form intelligence quotient (FSIQ) < 78 (1.5 standard deviations (SD) below mean)
  • conditions requiring acute intervention, e.g., active suicidality
  • non-English speaking child or parent.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CET-Working Memory (WM)
Central Executive Training: Working Memory
Behavioral: Central Executive Training: Working Memory
Computerized working memory training
Active Comparator: CET-Behavioral Inhibition (BI)
Central Executive Training: Inhibitory Control
Behavioral: Central Executive Training: Inhibitory Control
Computerized inhibitory control training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ADHD symptoms
Time Frame: Immediate post-treatment (within 2 weeks of final treatment session)
Average of T-scores on parent-report ADHD symptoms questionnaires (Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-5) Inattention and Hyperactivity subscales, Behavioral Assessment System for Children (BASC-3) Inattention and Hyperactivity subscales)
Immediate post-treatment (within 2 weeks of final treatment session)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Working Memory
Time Frame: Immediate post-treatment (within 2 weeks of final treatment session)
Average of stimuli correct per trial on the Rapport phonological and visuospatial working memory tests
Immediate post-treatment (within 2 weeks of final treatment session)
Inhibitory control
Time Frame: Immediate post-treatment (within 2 weeks of final treatment session)
Average of performance on the stop-signal (stop-signal delay metric) and go/no-go tests (commission errors)
Immediate post-treatment (within 2 weeks of final treatment session)
Actigraph-measured hyperactivity during working memory testing
Time Frame: Immediate post-treatment (within 2 weeks of final treatment session)
Proportional integrating measure (PIM) units from autographs worn on non dominant wrist, left ankle, and right ankle during Rapport working memory tests. PIM units from each actigraph will be aggregated by summing them to create a Total Hyperactivity Score.
Immediate post-treatment (within 2 weeks of final treatment session)
Actigraph-measured hyperactivity during baseline
Time Frame: Immediate post-treatment (within 2 weeks of final treatment session)
Proportional integrating measure (PIM) units from autographs worn on non dominant wrist, left ankle, and right ankle. During beginning and end of session baseline painting tasks (described in Rapport et al., 2009). PIM units from each actigraph will be aggregated by summing them to create a Total Hyperactivity Score.
Immediate post-treatment (within 2 weeks of final treatment session)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NIH List Sorting
Time Frame: Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Standard scores on NIH List Sorting test
Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Teacher-reported ADHD symptoms
Time Frame: Immediate post-treatment (within 2 weeks of final treatment session)
Average of T-scores on teacher-report ADHD symptoms questionnaires (ADHD-5 Inattention and Hyperactivity subscales, BASC-3 Inattention and Hyperactivity subscales)
Immediate post-treatment (within 2 weeks of final treatment session)
Academic performance rating scale (APRS)
Time Frame: Immediate post-treatment (within 2 weeks of final treatment session)
Total score (T-score) for academic performance (teacher ratings)
Immediate post-treatment (within 2 weeks of final treatment session)
Children's Organizational Skills Scale (COSS) Parent Report
Time Frame: Immediate post-treatment (within 2 weeks of final treatment session)
Parent-reported total organizational problems (T-score)
Immediate post-treatment (within 2 weeks of final treatment session)
Children's Organizational Skills Scale (COSS) Teacher Report
Time Frame: Immediate post-treatment (within 2 weeks of final treatment session)
Teacher-reported total organizational problems (T-score)
Immediate post-treatment (within 2 weeks of final treatment session)
Social Skills: Parent Report
Time Frame: Immediate post-treatment (within 2 weeks of final treatment session)
Parent-reported total score (standard score) on Social Skills Improvement System (SSIS)
Immediate post-treatment (within 2 weeks of final treatment session)
Social Skills: Teacher Report
Time Frame: Immediate post-treatment (within 2 weeks of final treatment session)
Teacher-reported total score (standard score) on Social Skills Improvement System (SSIS)
Immediate post-treatment (within 2 weeks of final treatment session)
Parent-child relationship quality
Time Frame: Immediate post-treatment (within 2 weeks of final treatment session)
Parent-reported total score (T-score) on Parent Relationship Questionnaire (PRQ)
Immediate post-treatment (within 2 weeks of final treatment session)
Kaufman Test of Educational Achievement Third Edition (KTEA-3) Reading Comprehension
Time Frame: Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Standard score on KTEA-3 Reading Comprehension subtest
Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Kaufman Test of Educational Achievement Third Edition (KTEA-3) Listening Comprehension
Time Frame: Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Standard score on KTEA-3 Listening Comprehension subtest
Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Kaufman Test of Educational Achievement Third Edition (KTEA-3) Reading Fluency
Time Frame: Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Standard score on KTEA-3 Reading Fluency subtest
Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Kaufman Test of Educational Achievement Third Edition (KTEA-3) Math Fluency
Time Frame: Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Standard score on KTEA-3 Math Fluency subtest
Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MH115048 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ADHD

Clinical Trials on Central Executive Training: Working Memory

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings