Central Executive Training (CET) for ADHD

Sponsor
Florida State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03324464
Collaborator
(none)
250
1
2
60
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Central Executive Training: Working Memory
  • Behavioral: Central Executive Training: Inhibitory Control
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Central Executive Training for ADHD: Efficacy Trial
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: CET-Working Memory (WM)

Central Executive Training: Working Memory

Behavioral: Central Executive Training: Working Memory
Computerized working memory training

Active Comparator: CET-Behavioral Inhibition (BI)

Central Executive Training: Inhibitory Control

Behavioral: Central Executive Training: Inhibitory Control
Computerized inhibitory control training

Outcome Measures

Primary Outcome Measures

  1. ADHD symptoms [Immediate post-treatment (within 2 weeks of final treatment session)]

    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)

Secondary Outcome Measures

  1. Working Memory [Immediate post-treatment (within 2 weeks of final treatment session)]

    Average of stimuli correct per trial on the Rapport phonological and visuospatial working memory tests

  2. Inhibitory control [Immediate post-treatment (within 2 weeks of final treatment session)]

    Average of performance on the stop-signal (stop-signal delay metric) and go/no-go tests (commission errors)

  3. Actigraph-measured hyperactivity during working memory testing [Immediate post-treatment (within 2 weeks of final treatment session)]

    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.

  4. Actigraph-measured hyperactivity during baseline [Immediate post-treatment (within 2 weeks of final treatment session)]

    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.

Other Outcome Measures

  1. NIH List Sorting [Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)]

    Standard scores on NIH List Sorting test

  2. Teacher-reported ADHD symptoms [Immediate post-treatment (within 2 weeks of final treatment session)]

    Average of T-scores on teacher-report ADHD symptoms questionnaires (ADHD-5 Inattention and Hyperactivity subscales, BASC-3 Inattention and Hyperactivity subscales)

  3. Academic performance rating scale (APRS) [Immediate post-treatment (within 2 weeks of final treatment session)]

    Total score (T-score) for academic performance (teacher ratings)

  4. Children's Organizational Skills Scale (COSS) Parent Report [Immediate post-treatment (within 2 weeks of final treatment session)]

    Parent-reported total organizational problems (T-score)

  5. Children's Organizational Skills Scale (COSS) Teacher Report [Immediate post-treatment (within 2 weeks of final treatment session)]

    Teacher-reported total organizational problems (T-score)

  6. Social Skills: Parent Report [Immediate post-treatment (within 2 weeks of final treatment session)]

    Parent-reported total score (standard score) on Social Skills Improvement System (SSIS)

  7. Social Skills: Teacher Report [Immediate post-treatment (within 2 weeks of final treatment session)]

    Teacher-reported total score (standard score) on Social Skills Improvement System (SSIS)

  8. Parent-child relationship quality [Immediate post-treatment (within 2 weeks of final treatment session)]

    Parent-reported total score (T-score) on Parent Relationship Questionnaire (PRQ)

  9. Kaufman Test of Educational Achievement Third Edition (KTEA-3) Reading Comprehension [Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)]

    Standard score on KTEA-3 Reading Comprehension subtest

  10. Kaufman Test of Educational Achievement Third Edition (KTEA-3) Listening Comprehension [Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)]

    Standard score on KTEA-3 Listening Comprehension subtest

  11. Kaufman Test of Educational Achievement Third Edition (KTEA-3) Reading Fluency [Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)]

    Standard score on KTEA-3 Reading Fluency subtest

  12. Kaufman Test of Educational Achievement Third Edition (KTEA-3) Math Fluency [Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)]

    Standard score on KTEA-3 Math Fluency subtest

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Florida State University Tallahassee Florida United States 32306

Sponsors and Collaborators

  • Florida State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael J. Kofler, Associate Professor, Florida State University
ClinicalTrials.gov Identifier:
NCT03324464
Other Study ID Numbers:
  • R01MH115048
First Posted:
Oct 27, 2017
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 28, 2022