Central Executive Training for ADHD (CET)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CET: Central Executive Training
CET: Comparison Executive Training
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
Eligibility Criteria
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
Sites / Locations
- Florida State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Central Executive Training1
Central Executive Training2
Arm Description
Training tasks targeting working memory
Training tasks targeting inhibitory control and response speed
Outcomes
Primary Outcome Measures
Rapport visuospatial/phonological working memory test
Outcome: stimuli correct
Secondary Outcome Measures
Parent-reported ADHD symptoms (ADHD-5 rating scale)
Full Information
NCT ID
NCT03042338
First Posted
December 16, 2016
Last Updated
February 1, 2021
Sponsor
Florida State University
Collaborators
National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03042338
Brief Title
Central Executive Training for ADHD
Acronym
CET
Official Title
Evaluating the Feasibility of Central Executive Training for Children With ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 31, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Central Executive Training1
Arm Type
Experimental
Arm Description
Training tasks targeting working memory
Arm Title
Central Executive Training2
Arm Type
Active Comparator
Arm Description
Training tasks targeting inhibitory control and response speed
Intervention Type
Behavioral
Intervention Name(s)
CET: Central Executive Training
Intervention Description
CET: Central Executive Training
Intervention Type
Behavioral
Intervention Name(s)
CET: Comparison Executive Training
Intervention Description
CET: Comparison Executive Training
Primary Outcome Measure Information:
Title
Rapport visuospatial/phonological working memory test
Description
Outcome: stimuli correct
Time Frame
Approximately 10 minute task administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session
Secondary Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
Kaufman Test of Educational Achievement-3 (KTEA3) Reading Comprehension
Description
Growth scale value (GSV)
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)
Title
NIH List Sorting
Description
Assessing feasibility of this test as possible primary outcomes for follow-up trial
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)
Title
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
Title
Inhibition test
Description
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).
Time Frame
Approximately 10 minute task administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session
Title
Kaufman Test of Educational Achievement-3 (KTEA3) Listening Comprehension
Description
Growth scale value (GSV)
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)
Title
Kaufman Test of Educational Achievement-3 (KTEA3) Math Concepts and Applications
Description
Growth scale value (GSV)
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)
Title
Kaufman Test of Educational Achievement-3 (KTEA3) Reading Fluency
Description
Growth scale value (GSV)
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)
Title
Kaufman Test of Educational Achievement-3 (KTEA3) Math Fluency
Description
Growth scale value (GSV)
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Central Executive Training for ADHD
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