Central Executive Training (CET) for ADHD

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.

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Behavioral: Central Executive Training: Working Memory; Behavioral: Central Executive Training: Inhibitory Control

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CET-Working Memory (WM); Central Executive Training: Working Memory	Behavioral: Central Executive Training: Working Memory; Computerized working memory training
Active Comparator: CET-Behavioral Inhibition (BI); Central Executive Training: Inhibitory Control	Behavioral: Central Executive Training: Inhibitory Control; Computerized inhibitory control training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Immediate post-treatment (within 2 weeks of final treatment session)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Working Memory	Average of stimuli correct per trial on the Rapport phonological and visuospatial working memory tests	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)	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.	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.	Immediate post-treatment (within 2 weeks of final treatment session)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIH List Sorting	Standard scores on NIH List Sorting test	Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
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)	Immediate post-treatment (within 2 weeks of final treatment session)
Academic performance rating scale (APRS)	Total score (T-score) for academic performance (teacher ratings)	Immediate post-treatment (within 2 weeks of final treatment session)
Children's Organizational Skills Scale (COSS) Parent Report	Parent-reported total organizational problems (T-score)	Immediate post-treatment (within 2 weeks of final treatment session)
Children's Organizational Skills Scale (COSS) Teacher Report	Teacher-reported total organizational problems (T-score)	Immediate post-treatment (within 2 weeks of final treatment session)
Social Skills: Parent Report	Parent-reported total score (standard score) on Social Skills Improvement System (SSIS)	Immediate post-treatment (within 2 weeks of final treatment session)
Social Skills: Teacher Report	Teacher-reported total score (standard score) on Social Skills Improvement System (SSIS)	Immediate post-treatment (within 2 weeks of final treatment session)
Parent-child relationship quality	Parent-reported total score (T-score) on Parent Relationship Questionnaire (PRQ)	Immediate post-treatment (within 2 weeks of final treatment session)
Kaufman Test of Educational Achievement Third Edition (KTEA-3) Reading Comprehension	Standard score on KTEA-3 Reading Comprehension subtest	Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Kaufman Test of Educational Achievement Third Edition (KTEA-3) Listening Comprehension	Standard score on KTEA-3 Listening Comprehension subtest	Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Kaufman Test of Educational Achievement Third Edition (KTEA-3) Reading Fluency	Standard score on KTEA-3 Reading Fluency subtest	Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Kaufman Test of Educational Achievement Third Edition (KTEA-3) Math Fluency	Standard score on KTEA-3 Math Fluency subtest	Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 5, 2024

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: R01MH115048 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No