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Completed

NCT Number: NCT03324464

Central Executive Training (CET) for ADHD

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Central Executive Training: Working Memory

Behavioral

Computerized working memory training

Central Executive Training: Inhibitory Control

Behavioral

Computerized inhibitory control training

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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)

  3. 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.

  4. 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.

Other outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

Central Executive Training for ADHD: Efficacy Trial

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Oct 27, 2017
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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