Evaluating the Efficacy of Central Executive Training (CET) For Young Children With ADHD

August 20, 2026 updated by: Michael J. Kofler, Florida State University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • 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

  • Name: Children's Learning Clinic
  • Phone Number: 850-645-7423
  • Email: clc@psy.fsu.edu

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32306
        • Recruiting
        • Children's Learning Clinic at Florida State University
        • Contact:
          • Children's Learning Clinic
          • Phone Number: 850-645-7423
          • Email: clc@psy.fsu.edu
        • Principal Investigator:
          • Michael Kofler, PhD

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • (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.

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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Central executive training
Behavioral: Central executive training
Computerized, adaptive central executive working memory training protocol
Active Comparator: Behavioral parent training
Behavioral: Behavioral parent training
Behavioral parent training
Other: Central executive training + concurrent behavioral parent training
Behavioral: Central executive training
Computerized, adaptive central executive working memory training protocol
Behavioral: Behavioral parent training
Behavioral parent training
No Intervention: Treatment as usual/waitlist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcomes (T-scores)
Time Frame: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Informant reports of social skills, emotion regulation, parent-child relationships, and impairments
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
Client satisfaction, system usability, expectancies
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion

Other Outcome Measures

Outcome Measure
Time Frame
Working memory test battery
Time Frame: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Actigraphy (Proportional Integrating Measure)
Time Frame: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Academic performance rating scale
Time Frame: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion

Collaborators and Investigators

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

Sponsor

Florida State University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Michael Kofler, PhD, 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)

May 1, 2024

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

August 5, 2026

First Submitted That Met QC Criteria

August 20, 2026

First Posted (Actual)

August 25, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4R33MH127031
  • 5R61MH127031 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing Time Frame

During peer review of study manuscript or after publication, after obtaining approval by the study's Data and Safety Monitoring Board (DSMB) and execution of a Data Use Agreement (DUA).

IPD Sharing Access Criteria

Approval by the study's Data and Safety Monitoring Board (DSMB) and execution of a Data Use Agreement (DUA).

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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