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Cognitive Training Trial

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ClinicalTrials.gov Identifier: NCT01133418
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : May 1, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jeff Epstein, Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date  ICMJE May 17, 2010
First Posted Date  ICMJE May 28, 2010
Results First Submitted Date January 17, 2017
Results First Posted Date May 1, 2017
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE September 2010
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2017)
  • Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale [ Time Frame: 2 months ]
    Total ADHD Symptom Score on the Parent Vanderbilt Rating Scales; range = 0-54; this score is computed by summing the 18 ADHD symptom items which are each rated on a 0-3 Likert scale (0="Never"; 1="Occasionally"; 2="Often"; 3="Very often"); higher scores indicate higher severity of ADHD symptoms.
  • Clinical Global Impression - Improvement [ Time Frame: 2 months ]
    Blinded ratings of clinical global impression - Improvement. Scale = 1 (Very Much Improved) - 7 (Very Much Worse) Lower scores represent more improvement.
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2010)
  • Vanderbilt Rating Scales [ Time Frame: 2 months ]
    Total ADHD Symptom Score on the Parent and Teacher Vanderbilt Rating Scales
  • Clinical Global Impression [ Time Frame: 2 months ]
    Blinded ratings of clinical global impression
Change History Complete list of historical versions of study NCT01133418 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2017)
  • Intra-individual Variability on Go/No-Go Task [ Time Frame: 2 months ]
    Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task
  • Academic Improvement Measurement System - Web-based (AIMSWEB) Reading Score (Proportion Accurate) [ Time Frame: 2 months ]
    Number of words read correctly divided by number of words read (range = 0-1.0) Higher values represent better reading accuracy
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2010)
  • Intra-individual Variability on Go/No-Go Task [ Time Frame: 2 months ]
    Reaction Time Standard Deviation on Go/No-Go Task
  • Reading Fluency [ Time Frame: 2 months ]
    AIMSWEB Reading Fluency Score
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Training Trial
Official Title  ICMJE Efficacy of a Cognitive Training Intervention for Children With ADHD
Brief Summary

Currently, only two treatment modalities for pediatric attention deficit hyperactivity disorder (ADHD) are considered evidence-based: (1) pharmacological and (2) behavioral treatment. Recently, several studies have shown promising results suggesting efficacy for cognitive training interventions for children with ADHD. These interventions directly train cognitive function (i.e., attention, working memory) by having children practice cognitive skills using computerized tasks. In these studies, improvements related to the cognitive training intervention have been documented on neuropsychological tests, academic tasks, and parent ratings of children's ADHD behavior. Given the ubiquitous finding of increased reaction time (RT) variability among children with ADHD, the candidate worked with a group of developers to modify a cognitive training intervention to target RT variability. That is, train the children to be less variable in their responding. Initial clinical data from this intervention suggest that intervention exposure improves behavioral outcomes. However, an appropriate powered randomized clinical trial is necessary to experimentally demonstrate intervention efficacy.Sixty-four (64) children diagnosed with ADHD (either Predominantly Inattentive Type or Combined Type) will be randomly assigned to intervention or control conditions. Children in the intervention group will receive 8 weeks of the Computerized Progressive Attention Training (CPAT) intervention. Children in the control group will receive the CPAT intervention but there will be no progression in difficulty based on performance as in the intervention group. Children in both groups will be assessed pre-intervention and immediately after the 8-week training on neuropsychological, behavioral, and academic outcome measures. Hypothesis-driven data analyses will assess intervention efficacy.

Hypothesis #1: Children in the experimental group exposed to the CPAT intervention will show greater improvement from pre- to post-intervention on neuropsychological tests compared to children in the control group.

Hypothesis #2: Children in the experimental group exposed to the CPAT intervention will show greater improvement from pre- to post-intervention on parent and teacher behavioral ratings of ADHD behavior compared to children in the control group.

Hypothesis #3: Children in the experimental group exposed to the CPAT intervention will show greater improvement from pre- to post-intervention on academic outcomes compared to children in the control group.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Hyperactivity Disorder
Intervention  ICMJE
  • Other: Computerized Progressive Attention Training
    Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability
  • Other: Sham Comparator Cognitive Training
    Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty
Study Arms
  • Experimental: Cognitive Training
    Computerized Progressive Attention Training
    Intervention: Other: Computerized Progressive Attention Training
  • Sham Comparator: Non-progressive cognitive training
    Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.
    Intervention: Other: Sham Comparator Cognitive Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2017)
72
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2010)
64
Actual Study Completion Date June 2016
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Consent: The family must provide signature of informed consent by parents or legal guardians.
  • Age at time of Screening: 7 to 12 years of age, inclusive.
  • Gender: includes male and female children.
  • ADHD Diagnostic Status: ADHD patients must meet DSM-IV criteria for ADHD-PIT or ADHD-CT subtype. Section D.4 below describes in detail the diagnostic process for arriving at diagnosis.
  • Cognitive Functioning: IQ of greater than 80 as estimated by the Wechsler Abbreviated Scale of Intelligence.
  • Learning Disability: Children must score above 75 on all three of the Wechsler Individual Achievement Test (WIAT) subtests (Reading, Spelling, Numerical Operations).
  • School: Children must be enrolled in a school setting from which teacher ratings can be obtained.

Exclusion Criteria:

  • Understanding Level. The patient and parent cannot understand or follow instructions given in the study.
  • History of Psychiatric Medications: Children must not have taken psychiatric medications within the past month. In addition, the family must indicate that they do not plan on placing their child on medication for any psychiatric condition during the course of the study.
  • Exclusionary Psychiatric Conditions: Children who meet diagnostic criteria on the K-SADS for OCD, any psychotic disorder, major depressive disorder or bipolar disorder will be excluded from participation.
  • Developmental Disabilities. Patients will be excluded if they are deemed to be significantly developmentally delayed or have a pervasive developmental disorder. Developmental delay will be operationally defined as an IQ score below 80. A pervasive developmental delay will be defined as a T score above 65 on the Autism Composite Scale of the PDD Behavior Inventory.
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 12 Years   (Child)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01133418
Other Study ID Numbers  ICMJE K24MH064478( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jeff Epstein, Children's Hospital Medical Center, Cincinnati
Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE Not Provided
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP