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Completed

NCT Number: NCT03042338

Central Executive Training for 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.

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Key information

Conditions

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

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

About this study

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.

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 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

Treatment and study plan

CET: Central Executive Training

Behavioral

CET: Central Executive Training

CET: Comparison Executive Training

Behavioral

CET: Comparison Executive Training

Primary outcomes

  1. Rapport visuospatial/phonological working memory test

    Time frame: Approximately 10 minute task administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session

    Outcome: stimuli correct

Secondary outcomes

  1. Parent-reported ADHD symptoms (ADHD-5 rating scale)

    Time frame: 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 outcomes

  1. Kaufman Test of Educational Achievement-3 (KTEA3) Reading Comprehension

    Time frame: 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)

    Growth scale value (GSV)

  2. NIH List Sorting

    Time frame: 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)

    Assessing feasibility of this test as possible primary outcomes for follow-up trial

  3. Teacher ADHD symptom ratings (ADHD-5 rating scale)

    Time frame: Teacher questionnaire requiring approximately 15 minutes to complete, mailed to teacher within 2 weeks of child's last intervention session

  4. Inhibition test

    Time frame: Approximately 10 minute task administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session

    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).

  5. Kaufman Test of Educational Achievement-3 (KTEA3) Listening Comprehension

    Time frame: 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)

    Growth scale value (GSV)

  6. Kaufman Test of Educational Achievement-3 (KTEA3) Math Concepts and Applications

    Time frame: 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)

    Growth scale value (GSV)

  7. Kaufman Test of Educational Achievement-3 (KTEA3) Reading Fluency

    Time frame: 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)

    Growth scale value (GSV)

  8. Kaufman Test of Educational Achievement-3 (KTEA3) Math Fluency

    Time frame: 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)

    Growth scale value (GSV)

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institutes of Health (NIH)

Registry information

Official study title

Evaluating the Feasibility of Central Executive Training for Children With ADHD

Acronym: CET

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 3, 2017
Registry last updated
Feb 3, 2021

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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