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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Interventions Other: Computerized Progressive Attention Training
Other: Sham Comparator Cognitive Training
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cognitive Training Non-progressive Cognitive Training
Hide Arm/Group Description

Computerized Progressive Attention Training

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

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.

Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty

Period Title: Overall Study
Started 34 38
Completed 29 32
Not Completed 5 6
Reason Not Completed
Lost to Follow-up             5             6
Arm/Group Title Cognitive Training Non-progressive Cognitive Training Total
Hide Arm/Group Description

Computerized Progressive Attention Training

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

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.

Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty

Total of all reporting groups
Overall Number of Baseline Participants 34 38 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 38 participants 72 participants
<=18 years
34
 100.0%
38
 100.0%
72
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 38 participants 72 participants
8.71  (1.53) 9.19  (1.84) 8.98  (1.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 38 participants 72 participants
Female
9
  26.5%
11
  28.9%
20
  27.8%
Male
25
  73.5%
27
  71.1%
52
  72.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 38 participants 72 participants
Hispanic or Latino
0
   0.0%
1
   2.6%
1
   1.4%
Not Hispanic or Latino
33
  97.1%
35
  92.1%
68
  94.4%
Unknown or Not Reported
1
   2.9%
2
   5.3%
3
   4.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 38 participants 72 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.6%
1
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   2.6%
1
   1.4%
Black or African American
6
  17.6%
7
  18.4%
13
  18.1%
White
27
  79.4%
27
  71.1%
54
  75.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.9%
2
   5.3%
3
   4.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 38 participants 72 participants
34 38 72
1.Primary Outcome
Title Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale
Hide Description 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.
Time Frame 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Training Non-progressive Cognitive Training
Hide Arm/Group Description:

Computerized Progressive Attention Training

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

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.

Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty

Overall Number of Participants Analyzed 29 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
27.00  (9.46) 26.63  (10.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Training, Non-progressive Cognitive Training
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .36
Comments a priori threshold for statistical significance was .05
Method General Linear Model
Comments [Not Specified]
2.Primary Outcome
Title Clinical Global Impression - Improvement
Hide Description Blinded ratings of clinical global impression - Improvement. Scale = 1 (Very Much Improved) - 7 (Very Much Worse) Lower scores represent more improvement.
Time Frame 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One child in the Cognitive Training Group and one child in the Non-progressive Cognitive Training group were missing CGI data.
Arm/Group Title Cognitive Training Non-progressive Cognitive Training
Hide Arm/Group Description:

Computerized Progressive Attention Training

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

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.

Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty

Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.28  (.81) 3.32  (.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Training, Non-progressive Cognitive Training
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .86
Comments [Not Specified]
Method General Linear Model
Comments [Not Specified]
3.Secondary Outcome
Title Intra-individual Variability on Go/No-Go Task
Hide Description Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task
Time Frame 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Training Non-progressive Cognitive Training
Hide Arm/Group Description:

Computerized Progressive Attention Training

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

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.

Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty

Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: milliseconds
242.24  (100.55) 236.60  (119.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Training, Non-progressive Cognitive Training
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .79
Comments [Not Specified]
Method General Linear Model
Comments [Not Specified]
4.Secondary Outcome
Title Academic Improvement Measurement System - Web-based (AIMSWEB) Reading Score (Proportion Accurate)
Hide Description Number of words read correctly divided by number of words read (range = 0-1.0) Higher values represent better reading accuracy
Time Frame 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Training Non-progressive Cognitive Training
Hide Arm/Group Description:

Computerized Progressive Attention Training

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

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.

Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty

Overall Number of Participants Analyzed 29 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
.97  (.03) .97  (.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Training, Non-progressive Cognitive Training
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .77
Comments [Not Specified]
Method General Linear Model
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive Training Non-progressive Cognitive Training
Hide Arm/Group Description

Computerized Progressive Attention Training

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

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.

Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty

All-Cause Mortality
Cognitive Training Non-progressive Cognitive Training
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive Training Non-progressive Cognitive Training
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/38 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cognitive Training Non-progressive Cognitive Training
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/38 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Jeff Epstein
Organization: Cincinnati Children's Hospital Medical Center
Phone: 5136368296
Responsible Party: Jeff Epstein, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01133418     History of Changes
Other Study ID Numbers: K24MH064478 ( U.S. NIH Grant/Contract )
First Submitted: May 17, 2010
First Posted: May 28, 2010
Results First Submitted: January 17, 2017
Results First Posted: May 1, 2017
Last Update Posted: May 30, 2017