Central Executive Training for ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

— CET  

Official title:

Evaluating the Feasibility of Central Executive Training for Children With ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042338
• Other study ID #: R34MH102499
• Secondary ID: R34MH102499
• Status: Completed
• Phase: N/A
• Start date: March 31, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: June 2018
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

Behavioral:
• CET: Central Executive Training
CET: Central Executive Training
• CET: Comparison Executive Training
CET: Comparison Executive Training

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Florida State University	National Institute of Mental Health (NIMH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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
Other	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
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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	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