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CompletedNCT03324464Updated Mar 7, 2025

Central Executive Training (CET) for ADHD

An interventional study of Central Executive Training: Working Memory and Central Executive Training: Inhibitory Control in ADHD, sponsored by Florida State University. Completed at 1 site in United States. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by Florida State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
251
Allocation
Randomized
Ages
8 Years to 12 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • ADHD
03

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
251 participants (actual)

Study arms

  • Experimental
    CET-Working Memory (WM)

    Central Executive Training: Working Memory

    Behavioral: Central Executive Training: Working Memory

  • Active comparator
    CET-Behavioral Inhibition (BI)

    Central Executive Training: Inhibitory Control

    Behavioral: Central Executive Training: Inhibitory Control

Interventions

  • BehavioralCentral Executive Training: Working Memory

    Computerized working memory training

  • BehavioralCentral Executive Training: Inhibitory Control

    Computerized inhibitory control training

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Immediate post-treatment (within 2 weeks of final treatment session)

Secondary outcomes

  1. Working Memory

    Average of stimuli correct per trial on the Rapport phonological and visuospatial working memory tests

    Time frame: Immediate post-treatment (within 2 weeks of final treatment session)

  2. Inhibitory control

    Average of performance on the stop-signal (stop-signal delay metric) and go/no-go tests (commission errors)

    Time frame: Immediate post-treatment (within 2 weeks of final treatment session)

  3. 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.

    Time frame: Immediate post-treatment (within 2 weeks of final treatment session)

  4. 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.

    Time frame: Immediate post-treatment (within 2 weeks of final treatment session)

Other outcomes

  1. NIH List Sorting

    Standard scores on NIH List Sorting test

    Time frame: Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)

  2. Teacher-reported ADHD symptoms

    Average of T-scores on teacher-report ADHD symptoms questionnaires (ADHD-5 Inattention and Hyperactivity subscales, BASC-3 Inattention and Hyperactivity subscales)

    Time frame: Immediate post-treatment (within 2 weeks of final treatment session)

  3. Academic performance rating scale (APRS)

    Total score (T-score) for academic performance (teacher ratings)

    Time frame: Immediate post-treatment (within 2 weeks of final treatment session)

  4. Children's Organizational Skills Scale (COSS) Parent Report

    Parent-reported total organizational problems (T-score)

    Time frame: Immediate post-treatment (within 2 weeks of final treatment session)

  5. Children's Organizational Skills Scale (COSS) Teacher Report

    Teacher-reported total organizational problems (T-score)

    Time frame: Immediate post-treatment (within 2 weeks of final treatment session)

  6. Social Skills: Parent Report

    Parent-reported total score (standard score) on Social Skills Improvement System (SSIS)

    Time frame: Immediate post-treatment (within 2 weeks of final treatment session)

  7. Social Skills: Teacher Report

    Teacher-reported total score (standard score) on Social Skills Improvement System (SSIS)

    Time frame: Immediate post-treatment (within 2 weeks of final treatment session)

  8. Parent-child relationship quality

    Parent-reported total score (T-score) on Parent Relationship Questionnaire (PRQ)

    Time frame: Immediate post-treatment (within 2 weeks of final treatment session)

  9. Kaufman Test of Educational Achievement Third Edition (KTEA-3) Reading Comprehension

    Standard score on KTEA-3 Reading Comprehension subtest

    Time frame: Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)

  10. Kaufman Test of Educational Achievement Third Edition (KTEA-3) Listening Comprehension

    Standard score on KTEA-3 Listening Comprehension subtest

    Time frame: Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)

  11. Kaufman Test of Educational Achievement Third Edition (KTEA-3) Reading Fluency

    Standard score on KTEA-3 Reading Fluency subtest

    Time frame: Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)

  12. Kaufman Test of Educational Achievement Third Edition (KTEA-3) Math Fluency

    Standard score on KTEA-3 Math Fluency subtest

    Time frame: Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)

06

Study locations

1 site
  • Florida State University
    Tallahassee, Florida 32306, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03324464
Lead sponsor
Florida State University
Responsible party
Michael J. Kofler (Associate Professor, Florida State University) — Principal investigator
First posted
Oct 27, 2017
Start date
Jan 1, 2018
Primary completion
Dec 31, 2023
Completion
Jan 5, 2024
Last update
Mar 7, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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