Clinical trial NCT03324464: Central Executive Training (CET) for ADHD
Official title: Central Executive Training for ADHD: Efficacy Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 251
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: ADHD symptoms
timeFrame: Immediate post-treatment (within 2 weeks of final treatment session)
Secondary outcomes:
measure: Working Memory
timeFrame: Immediate post-treatment (within 2 weeks of final treatment session)
measure: Inhibitory control
timeFrame: Immediate post-treatment (within 2 weeks of final treatment session)
measure: Actigraph-measured hyperactivity during working memory testing
timeFrame: Immediate post-treatment (within 2 weeks of final treatment session)
measure: Actigraph-measured hyperactivity during baseline
timeFrame: Immediate post-treatment (within 2 weeks of final treatment session)
Other outcomes:
measure: NIH List Sorting
timeFrame: Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
measure: Teacher-reported ADHD symptoms
timeFrame: Immediate post-treatment (within 2 weeks of final treatment session)
measure: Academic performance rating scale (APRS)
timeFrame: Immediate post-treatment (within 2 weeks of final treatment session)
measure: Children's Organizational Skills Scale (COSS) Parent Report
timeFrame: Immediate post-treatment (within 2 weeks of final treatment session)
measure: Children's Organizational Skills Scale (COSS) Teacher Report
timeFrame: Immediate post-treatment (within 2 weeks of final treatment session)
measure: Social Skills: Parent Report
timeFrame: Immediate post-treatment (within 2 weeks of final treatment session)
measure: Social Skills: Teacher Report
timeFrame: Immediate post-treatment (within 2 weeks of final treatment session)
measure: Parent-child relationship quality
timeFrame: Immediate post-treatment (within 2 weeks of final treatment session)
measure: Kaufman Test of Educational Achievement Third Edition (KTEA-3) Reading Comprehension
timeFrame: Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
measure: Kaufman Test of Educational Achievement Third Edition (KTEA-3) Listening Comprehension
timeFrame: Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
measure: Kaufman Test of Educational Achievement Third Edition (KTEA-3) Reading Fluency
timeFrame: Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
measure: Kaufman Test of Educational Achievement Third Edition (KTEA-3) Math Fluency
timeFrame: Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References: