Central Executive Training for ADHD (CET)

Evaluating the Feasibility of Central Executive Training for Children With ADHD

Feasibility study of Central Executive Training (CET) for ADHD. The goal of the current project is to develop and assess the feasibility, acceptability, engagement, and usability of a novel, central executive (CE) working memory training intervention.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Behavioral: CET: Central Executive Training; Behavioral: CET: Comparison Executive Training

Detailed Description

The goal of the core study is to develop a central executive training (CET) intervention for children with attention-deficit/hyperactivity disorder (ADHD) and examine its feasibility, acceptability, engagement, and usability. This will involve early developmental work on software and treatment manuals followed by evaluation of the feasibility of enrolling, retaining, and treating ADHD children with CET. An evidence-informed intervention targeting central executive functioning in children with ADHD has the potential to result in clinically significant improvements in ADHD symptoms relative to extant behavioral treatments and capacity-based (short-term memory) training interventions. The long-term goal is to develop an efficacious and acceptable CET intervention with the potential for generalized improvements in, or normalization of, ADHD-related impairments in peer, family, and academic functioning.

• Study Type: Interventional
• Enrollment (Actual): 54
• 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 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children ages 8-12 with principal ADHD diagnoses (via K-SADS)
• parent Behavior Assessment System for Children (BASC) Attention Problems or Hyperactivity subscale or ADHD-5 in clinical/borderline range based on age and gender
• teacher BASC Attention Problems or Hyperactivity subscale or ADHD-5 scale in clinical/borderline range based on age and gender.

Exclusion Criteria:

• gross neurological, sensory, or motor impairment, history of a seizure disorder, or psychosis, bipolar disorders, substance use, or intellectual disability disorders
• non-English speaking child or parent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Central Executive Training1; Training tasks targeting working memory	Behavioral: CET: Central Executive Training; CET: Central Executive Training
Active Comparator: Central Executive Training2; Training tasks targeting inhibitory control and response speed	Behavioral: CET: Comparison Executive Training; CET: Comparison Executive Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rapport visuospatial/phonological working memory test	Outcome: stimuli correct	Approximately 10 minute task administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session

Secondary Outcome Measures

Outcome Measure	Time Frame
Parent-reported ADHD symptoms (ADHD-5 rating scale)	Parent questionnaire requiring approximately 15 minutes to complete, administered to parent while child is completing the 3 hour post-treatment testing session occurring within 2 weeks of last intervention session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kaufman Test of Educational Achievement-3 (KTEA3) Reading Comprehension	Growth scale value (GSV)	Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)
NIH List Sorting	Assessing feasibility of this test as possible primary outcomes for follow-up trial	Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)
Teacher ADHD symptom ratings (ADHD-5 rating scale)		Teacher questionnaire requiring approximately 15 minutes to complete, mailed to teacher within 2 weeks of child's last intervention session
Inhibition test	Stop-signal and go/no-go scores will be combined via weighted average (factor score). Divergent validity (expected to improve more in comparison condition than experimental condition).	Approximately 10 minute task administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session
Kaufman Test of Educational Achievement-3 (KTEA3) Listening Comprehension	Growth scale value (GSV)	Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)
Kaufman Test of Educational Achievement-3 (KTEA3) Math Concepts and Applications	Growth scale value (GSV)	Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)
Kaufman Test of Educational Achievement-3 (KTEA3) Reading Fluency	Growth scale value (GSV)	Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)
Kaufman Test of Educational Achievement-3 (KTEA3) Math Fluency	Growth scale value (GSV)	Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: National Institute of Mental Health (NIMH); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: R34MH102499 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No