Central Executive Training (CET) for ADHD

Study Overview
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Brief Summary
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The goal of the current project is to assess the efficacy of Central Executive Training (CET) for youth with ADHD. CET is a new, computerized training intervention that targets specific components of the working memory system. Two versions of CET were developed as part of our R34, each targeting a different combinations of executive functions. The final CET protocol reflects the contributions and feedback of a diverse group of caregivers, children with ADHD, and recognized experts in human cognition, ADHD treatment research, randomized control trial (RCT) intervention design methods, serious game theory and task design, cognitive training, and the role of executive dysfunction in ADHD.

Official Title
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Central Executive Training for ADHD: Efficacy Trial

Conditions
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ADHD

Intervention / Treatment
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* Behavioral: Central Executive Training: Working Memory
* Behavioral: Central Executive Training: Inhibitory Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children ages 8-12 with principal ADHD diagnoses (via Kiddie Schedule for Affective Disorders semi-structured clinical interviewing (K-SADS) Parent AND teacher ratings in clinical/borderline range based on age and gender on ADHD-RS-5 or BASC-3 Attention Problems/Hyperactivity subscales Below average or lower working memory on at least one pre-treatment WM test. All ADHD presentations will be eligible. Exclusion Criteria: gross neurological, sensory, or motor impairment history of seizure disorder, psychosis, bipolar, or severe dysregulation disorders that may interfere with study participation (substance use, disruptive mood dysregulation, intermittent explosive, reactive attachment) intellectual disability or Wechsler Intelligence Scale for Children (WISC-V) short-form intelligence quotient (FSIQ) < 78 (1.5 standard deviations (SD) below mean) conditions requiring acute intervention, e.g., active suicidality non-English speaking child or parent.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CET-Working Memory (WM)<br>Central Executive Training: Working Memory | Behavioral: Central Executive Training: Working Memory<br>* Computerized working memory training<br>|
| Active Comparator: CET-Behavioral Inhibition (BI)<br>Central Executive Training: Inhibitory Control | Behavioral: Central Executive Training: Inhibitory Control<br>* Computerized inhibitory control training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD symptoms | Average of T-scores on parent-report ADHD symptoms questionnaires (Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-5) Inattention and Hyperactivity subscales, Behavioral Assessment System for Children (BASC-3) Inattention and Hyperactivity subscales) | Immediate post-treatment (within 2 weeks of final treatment session) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Working Memory | Average of stimuli correct per trial on the Rapport phonological and visuospatial working memory tests | Immediate post-treatment (within 2 weeks of final treatment session) | 
| Inhibitory control | Average of performance on the stop-signal (stop-signal delay metric) and go/no-go tests (commission errors) | Immediate post-treatment (within 2 weeks of final treatment session) | 
| Actigraph-measured hyperactivity during working memory testing | Proportional integrating measure (PIM) units from autographs worn on non dominant wrist, left ankle, and right ankle during Rapport working memory tests. PIM units from each actigraph will be aggregated by summing them to create a Total Hyperactivity Score. | Immediate post-treatment (within 2 weeks of final treatment session) | 
| Actigraph-measured hyperactivity during baseline | Proportional integrating measure (PIM) units from autographs worn on non dominant wrist, left ankle, and right ankle. During beginning and end of session baseline painting tasks (described in Rapport et al., 2009). PIM units from each actigraph will be aggregated by summing them to create a Total Hyperactivity Score. | Immediate post-treatment (within 2 weeks of final treatment session) |