Clinical trial NCT03042338: Central Executive Training for ADHD
Official title: Evaluating the Feasibility of Central Executive Training for Children With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
First posted: 2017-02-03
Enrollment: 54
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rapport visuospatial/phonological working memory test
timeFrame: Approximately 10 minute task administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session
Secondary outcomes:
measure: Parent-reported ADHD symptoms (ADHD-5 rating scale)
timeFrame: 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:
measure: Kaufman Test of Educational Achievement-3 (KTEA3) Reading Comprehension
timeFrame: 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)
measure: NIH List Sorting
timeFrame: 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)
measure: Teacher ADHD symptom ratings (ADHD-5 rating scale)
timeFrame: Teacher questionnaire requiring approximately 15 minutes to complete, mailed to teacher within 2 weeks of child's last intervention session
measure: Inhibition test
timeFrame: Approximately 10 minute task administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session
measure: Kaufman Test of Educational Achievement-3 (KTEA3) Listening Comprehension
timeFrame: 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)
measure: Kaufman Test of Educational Achievement-3 (KTEA3) Math Concepts and Applications
timeFrame: 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)
measure: Kaufman Test of Educational Achievement-3 (KTEA3) Reading Fluency
timeFrame: 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)
measure: Kaufman Test of Educational Achievement-3 (KTEA3) Math Fluency
timeFrame: 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)
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References: