ADHDNCT07784348
Evaluating the Efficacy of Central Executive Training (CET) For Young Children With ADHD
A study testing Central executive training and Behavioral parent training in people with ADHD, run by Florida State University at 1 site in United States.
Trial summary
Initial non-randomized trial of behavioral parent training (BPT) compared to central executive training (CET), followed by a randomized controlled trial of CET+BPT for young children with ADHD. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- ADHD
- What is being tested?
- Central executive training and Behavioral parent training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- principal ADHD diagnoses (via K-SADS); (b) parent BASC-3 ADHD Problems or ADHD-RS ADHD-Combined scale in clinical/borderline range (>90th percentile) based on age and sex; (c) teacher BASC-3 ADHD Problems or ADHD-RS ADHD-Combined scale in clinical/borderline range based on age and sex
Who cannot join
- (a) gross neurological, sensory, or motor impairment; (b) history of seizure disorder, psychosis, bipolar, or severe dysregulation disorders that may interfere with study participation (e.g., disruptive mood dysregulation, conduct, intermittent explosive, reactive attachment); (c) intellectual disability or WPPSI/WISC short-form FSIQ<70; (d) conditions requiring acute intervention, e.g., active suicidality; and (e) non-English speaking child or parent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Learning Clinic at Florida State University
Tallahassee, Florida, 32306
Children's Learning Clinic, 850-645-7423, clc@psy.fsu.edu
Michael Kofler, PhD
About this study
Initial non-randomized trial of behavioral parent training (BPT) compared to central executive training (CET), followed by a randomized controlled trial of CET+BPT for young children with ADHD.
Read the detailed description
Initial non-randomized trial of behavioral parent training (BPT) compared to central executive training (CET) [R61 Phase], followed by a randomized controlled trial of CET+BPT for young children with ADHD [R33 Phase].
- Conditions
- ADHD
- Being tested
- Central executive training, Behavioral parent training
- Keywords
- ADHD, Central Executive Training, Behavioral Parent Training
- 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 trainingBehavioural
Computerized, adaptive central executive working memory training protocol
Behavioral parent trainingBehavioural
Behavioral parent training
| Study group | Role | What they receive |
|---|---|---|
| Central executive training | Experimental | Not described Receives: Behavioral: Central executive training |
| Behavioral parent training | Active comparator | Not described Receives: Behavioral: Behavioral parent training |
| Central executive training + concurrent behavioral parent training | Other | Not described Receives: Behavioral: Central executive training; Behavioral: Behavioral parent training |
| Treatment as usual/waitlist | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD Rating Scale (ADHD-RS)
Measured: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Secondary outcomes (2)
Secondary outcomes (T-scores)
Informant reports of social skills, emotion regulation, parent-child relationships, and impairments
Measured: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Feasibility/acceptability
Client satisfaction, system usability, expectancies
Measured: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 May 2024
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michael J. Kofler, Florida State University
- Investigators
- Michael Kofler, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784348
- Sponsor's protocol ID
- 4R33MH127031
- Other IDs
- 5R61MH127031
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data that underlie results in a publication will be shared upon reasonable request, subject to approval by the study's Data and Safety Monitoring Board (DSMB) and execution of a Data Use Agreement (DUA).
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Central Executive Training (CET) For Young Children With ADHD
- ClinicalTrials.gov ID
- NCT07784348
- Acronym / sponsor ID
- 4R33MH127031
- Conditions
- ADHD
- Keywords
- ADHD, Central Executive Training, Behavioral Parent Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 May 2024 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 25 Aug 2026 (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.
Initial non-randomized trial of behavioral parent training (BPT) compared to central executive training (CET), followed by a randomized controlled trial of CET+BPT for young children with ADHD.
Detailed description
Initial non-randomized trial of behavioral parent training (BPT) compared to central executive training (CET) [R61 Phase], followed by a randomized controlled trial of CET+BPT for young children with ADHD [R33 Phase].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Central executive training | Experimental | Behavioral: Central executive training |
| Behavioral parent training | Active comparator | Behavioral: Behavioral parent training |
| Central executive training + concurrent behavioral parent training | Other | Behavioral: Central executive training, Behavioral: Behavioral parent training |
| Treatment as usual/waitlist | No intervention | – |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- principal ADHD diagnoses (via K-SADS); (b) parent BASC-3 ADHD Problems or ADHD-RS ADHD-Combined scale in clinical/borderline range (>90th percentile) based on age and sex; (c) teacher BASC-3 ADHD Problems or ADHD-RS ADHD-Combined scale in clinical/borderline range based on age and sex
Key exclusion criteria (1 listed)
- (a) gross neurological, sensory, or motor impairment; (b) history of seizure disorder, psychosis, bipolar, or severe dysregulation disorders that may interfere with study participation (e.g., disruptive mood dysregulation, conduct, intermittent explosive, reactive attachment); (c) intellectual disability or WPPSI/WISC short-form FSIQ<70; (d) conditions requiring acute intervention, e.g., active suicidality; and (e) 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 trainingComputerized, adaptive central executive working memory training protocol | Behavioural | Central executive training, Central executive training + concurrent behavioral parent training |
| Behavioral parent trainingBehavioral parent training | Behavioural | Behavioral parent training, Central executive training + concurrent behavioral parent training |
Primary outcome
ADHD Rating Scale (ADHD-RS)
Time frame: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
2 secondary outcomes
Secondary outcomes (T-scores)
Time frame: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Feasibility/acceptability
Time frame: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data that underlie results in a publication will be shared upon reasonable request, subject to approval by the study's Data and Safety Monitoring Board (DSMB) and execution of a Data Use Agreement (DUA).
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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.
Michael Kofler, PhD principal investigator
Florida State University
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 and Behavioral parent training 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Children's Learning Clinic (850-645-7423, clc@psy.fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD Rating Scale (ADHD-RS) (time frame: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2026.