Central Executive Training (CET) for ADHD

ADHD Clinical Trial

Official title:

Central Executive Training for ADHD: Efficacy Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03324464
• Other study ID #: R01MH115048
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Florida State University
• Contact: Michael Kofler, PhD
• Phone: 850-645-7423
• Email: clc[@]psy.fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• Central Executive Training: Working Memory
Computerized working memory training
• Central Executive Training: Inhibitory Control
Computerized inhibitory control training

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NIH List Sorting	Standard scores on NIH List Sorting test	Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Other	Teacher-reported ADHD symptoms	Average of T-scores on teacher-report ADHD symptoms questionnaires (ADHD-5 Inattention and Hyperactivity subscales, BASC-3 Inattention and Hyperactivity subscales)	Immediate post-treatment (within 2 weeks of final treatment session)
Other	Academic performance rating scale (APRS)	Total score (T-score) for academic performance (teacher ratings)	Immediate post-treatment (within 2 weeks of final treatment session)
Other	Children's Organizational Skills Scale (COSS) Parent Report	Parent-reported total organizational problems (T-score)	Immediate post-treatment (within 2 weeks of final treatment session)
Other	Children's Organizational Skills Scale (COSS) Teacher Report	Teacher-reported total organizational problems (T-score)	Immediate post-treatment (within 2 weeks of final treatment session)
Other	Social Skills: Parent Report	Parent-reported total score (standard score) on Social Skills Improvement System (SSIS)	Immediate post-treatment (within 2 weeks of final treatment session)
Other	Social Skills: Teacher Report	Teacher-reported total score (standard score) on Social Skills Improvement System (SSIS)	Immediate post-treatment (within 2 weeks of final treatment session)
Other	Parent-child relationship quality	Parent-reported total score (T-score) on Parent Relationship Questionnaire (PRQ)	Immediate post-treatment (within 2 weeks of final treatment session)
Other	Kaufman Test of Educational Achievement Third Edition (KTEA-3) Reading Comprehension	Standard score on KTEA-3 Reading Comprehension subtest	Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Other	Kaufman Test of Educational Achievement Third Edition (KTEA-3) Listening Comprehension	Standard score on KTEA-3 Listening Comprehension subtest	Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Other	Kaufman Test of Educational Achievement Third Edition (KTEA-3) Reading Fluency	Standard score on KTEA-3 Reading Fluency subtest	Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Other	Kaufman Test of Educational Achievement Third Edition (KTEA-3) Math Fluency	Standard score on KTEA-3 Math Fluency subtest	Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)