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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH102499 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Central Executive Training1 | Experimental | Training tasks targeting working memory |
|
| Central Executive Training2 | Active Comparator | Training tasks targeting inhibitory control and response speed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CET: Central Executive Training | Behavioral | CET: Central Executive Training |
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| 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 |
| Measure | Description | 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Tallahassee | Florida | 32306 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2017 | Feb 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| CET: Comparison Executive Training | Behavioral | CET: Comparison Executive Training |
|
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) |