NCT03042338

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 31, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

February 3, 2021

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

December 16, 2016

Last Update Submit

February 1, 2021

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • Rapport visuospatial/phonological working memory test

    Outcome: stimuli correct

    Approximately 10 minute task administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session

Secondary Outcomes (1)

  • Parent-reported ADHD symptoms (ADHD-5 rating scale)

    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 Outcomes (8)

  • Kaufman Test of Educational Achievement-3 (KTEA3) Reading Comprehension

    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)

  • NIH List Sorting

    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)

  • Teacher ADHD symptom ratings (ADHD-5 rating scale)

    Teacher questionnaire requiring approximately 15 minutes to complete, mailed to teacher within 2 weeks of child's last intervention session

  • +5 more other outcomes

Study Arms (2)

Central Executive Training1

EXPERIMENTAL

Training tasks targeting working memory

Behavioral: CET: Central Executive Training

Central Executive Training2

ACTIVE COMPARATOR

Training tasks targeting inhibitory control and response speed

Behavioral: CET: Comparison Executive Training

Interventions

CET: Central Executive TrainingBEHAVIORAL

CET: Central Executive Training

Central Executive Training1
CET: Comparison Executive TrainingBEHAVIORAL

CET: Comparison Executive Training

Central Executive Training2

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 16, 2016

First Posted

February 3, 2017

Study Start

March 31, 2017

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

February 3, 2021

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)