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Trial record 24 of 99 for:    ADHD | Open Studies | United States | Child, Adult

Central Executive Training for ADHD (CET)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Florida State University
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Florida State University
ClinicalTrials.gov Identifier:
NCT03042338
First received: December 16, 2016
Last updated: April 17, 2017
Last verified: December 2016
  Purpose
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.

Condition Intervention
Attention Deficit Hyperactivity Disorder
Behavioral: CET: Central Executive Training
Behavioral: CET: Comparison Executive Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Evaluating the Feasibility of Central Executive Training for Children With ADHD

Further study details as provided by Florida State University:

Primary Outcome Measures:
  • Rapport visuospatial/phonological working memory test [ Time Frame: Approximately 10 minute task administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session ]
    Outcome: stimuli correct


Secondary Outcome Measures:
  • Parent-reported ADHD symptoms (ADHD-5 rating scale) [ Time Frame: 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 ]

Other Outcome Measures:
  • Kaufman Test of Educational Achievement-3 (KTEA3) Reading Comprehension [ Time Frame: 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) ]
    Growth scale value (GSV)

  • NIH List Sorting [ Time Frame: 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) ]
    Assessing feasibility of this test as possible primary outcomes for follow-up trial

  • Teacher ADHD symptom ratings (ADHD-5 rating scale) [ Time Frame: Teacher questionnaire requiring approximately 15 minutes to complete, mailed to teacher within 2 weeks of child's last intervention session ]
  • Inhibition test [ Time Frame: Approximately 10 minute task administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session ]
    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).

  • Kaufman Test of Educational Achievement-3 (KTEA3) Listening Comprehension [ Time Frame: 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) ]
    Growth scale value (GSV)

  • Kaufman Test of Educational Achievement-3 (KTEA3) Math Concepts and Applications [ Time Frame: 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) ]
    Growth scale value (GSV)

  • Kaufman Test of Educational Achievement-3 (KTEA3) Reading Fluency [ Time Frame: 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) ]
    Growth scale value (GSV)

  • Kaufman Test of Educational Achievement-3 (KTEA3) Math Fluency [ Time Frame: 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) ]
    Growth scale value (GSV)


Estimated Enrollment: 30
Actual Study Start Date: March 31, 2017
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Central Executive Training1
Training tasks targeting working memory
Behavioral: CET: Central Executive Training
Active Comparator: Central Executive Training2
Training tasks targeting inhibitory control and response speed
Behavioral: CET: Comparison Executive Training

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children ages 8-12 with principal ADHD diagnoses (via K-SADS)
  • parent Behavior Assessment System for Children (BASC) Attention Problems or Hyperactivity subscale or ADHD-5 in clinical/borderline range based on age and gender
  • teacher BASC Attention Problems or Hyperactivity subscale or ADHD-5 scale in clinical/borderline range based on age and gender.

Exclusion Criteria:

  • gross neurological, sensory, or motor impairment, history of a seizure disorder, or psychosis, bipolar disorders, substance use, or intellectual disability disorders
  • non-English speaking child or parent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03042338

Contacts
Contact: Michael Kofler, PhD 850-645-7423 clc@psy.fsu.edu

Locations
United States, Florida
Florida State University Recruiting
Tallahassee, Florida, United States, 32306
Contact: Michael Kofler, PhD    850-645-7423    clc@psy.fsu.edu   
Sponsors and Collaborators
Florida State University
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
  More Information

Responsible Party: Florida State University
ClinicalTrials.gov Identifier: NCT03042338     History of Changes
Other Study ID Numbers: R34MH102499 ( US NIH Grant/Contract Award Number )
Study First Received: December 16, 2016
Last Updated: April 17, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2017