ADHDNCT03324464
Central Executive Training (CET) for ADHD
A study testing Central Executive Training: Working Memory in people with ADHD, run by Florida State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- Central Executive Training: Working Memory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 5 Jan 2024
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: 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.
- Conditions
- ADHD
- Being tested
- Central Executive Training: Working Memory, Central Executive Training: Inhibitory Control
- 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.
Central Executive Training: Working MemoryBehavioural
Computerized working memory training
Central Executive Training: Inhibitory ControlBehavioural
Computerized inhibitory control training
| Study group | Role | What they receive |
|---|---|---|
| CET-Working Memory (WM) | Experimental | Central Executive Training: Working Memory Receives: Behavioral: Central Executive Training: Working Memory |
| CET-Behavioral Inhibition (BI) | Active comparator | Central Executive Training: Inhibitory Control Receives: Behavioral: Central Executive Training: Inhibitory Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD symptoms
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)
Measured: Immediate post-treatment (within 2 weeks of final treatment session)
Secondary outcomes (4)
Working Memory
Average of stimuli correct per trial on the Rapport phonological and visuospatial working memory tests
Measured: Immediate post-treatment (within 2 weeks of final treatment session)
Inhibitory control
Average of performance on the stop-signal (stop-signal delay metric) and go/no-go tests (commission errors)
Measured: Immediate post-treatment (within 2 weeks of final treatment session)
Actigraph-measured hyperactivity during working memory testing
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.
Measured: Immediate post-treatment (within 2 weeks of final treatment session)
Actigraph-measured hyperactivity during baseline
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.
Measured: Immediate post-treatment (within 2 weeks of final treatment session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Jan 2018
- Primary completion31 Dec 2023
- Study completion5 Jan 2024
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 ADHDStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Kofler, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324464
- Sponsor's protocol ID
- R01MH115048
- Status last verified
- Mar 2025
- First submitted
- 9 Oct 2017
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Groves NB, Chan ESM, Marsh CL, Gaye F, Jaisle EM, Kofler MJ. Does central executive training and/or inhibitory control training improve emotion regulation for children with attention-deficit/hyperactivity disorder? A randomized controlled trial. Front Psychiatry. 2022 Dec 6;13:1034722. doi: 10.3389/fpsyt.2022.1034722. eCollection 2022.
PubMed 36561637
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Executive Training for ADHD: Efficacy Trial
- ClinicalTrials.gov ID
- NCT03324464
- Acronym / sponsor ID
- R01MH115048
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 27 Oct 2017 (actual)
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CET-Working Memory (WM) | Experimental | Behavioral: Central Executive Training: Working MemoryCentral Executive Training: Working Memory |
| CET-Behavioral Inhibition (BI) | Active comparator | Behavioral: Central Executive Training: Inhibitory ControlCentral Executive Training: Inhibitory Control |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Central Executive Training: Working MemoryComputerized working memory training | Behavioural | CET-Working Memory (WM) |
| Central Executive Training: Inhibitory ControlComputerized inhibitory control training | Behavioural | CET-Behavioral Inhibition (BI) |
Primary outcome
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)
4 secondary outcomes
Working Memory
Time frame: Immediate post-treatment (within 2 weeks of final treatment session)
Inhibitory control
Time frame: 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)
Actigraph-measured hyperactivity during baseline
Time frame: Immediate post-treatment (within 2 weeks of final treatment session)
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 7 Mar 2025.
- Derived from this study: PubMed 36561637Groves NB, Chan ESM, Marsh CL, Gaye F, Jaisle EM, Kofler MJ. Does central executive training and/or inhibitory control training improve emotion regulation for children with attention-deficit/hyperactivity disorder? A randomized controlled trial. Front Psychiatry. 2022 Dec 6;13:1034722. doi: 10.3389/fpsyt.2022.1034722. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Central Executive Training: Working Memory in people with ADHD, run by Florida State University 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 3 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 7 Mar 2025. 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?
ADHD symptoms (time frame: Immediate post-treatment (within 2 weeks of final treatment session)). 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 NCT03324464, 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 7 Mar 2025.