Trial Outcomes & Findings for Cognitive Training Trial (NCT NCT01133418)
NCT ID: NCT01133418
Last Updated: 2017-05-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
2 months
Results posted on
2017-05-30
Participant Flow
Participant milestones
| Measure |
Cognitive Training
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
|
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.
Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
38
|
|
Overall Study
COMPLETED
|
29
|
32
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Cognitive Training
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
|
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.
Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
Baseline Characteristics
Cognitive Training Trial
Baseline characteristics by cohort
| Measure |
Cognitive Training
n=34 Participants
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
|
Non-progressive Cognitive Training
n=38 Participants
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
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
34 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8.71 years
STANDARD_DEVIATION 1.53 • n=5 Participants
|
9.19 years
STANDARD_DEVIATION 1.84 • n=7 Participants
|
8.98 years
STANDARD_DEVIATION 1.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
38 participants
n=7 Participants
|
72 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsTotal 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.
Outcome measures
| Measure |
Cognitive Training
n=29 Participants
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
|
Non-progressive Cognitive Training
n=32 Participants
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 ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale
|
27.00 units on a scale
Standard Deviation 9.46
|
26.63 units on a scale
Standard Deviation 10.08
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: One child in the Cognitive Training Group and one child in the Non-progressive Cognitive Training group were missing CGI data.
Blinded ratings of clinical global impression - Improvement. Scale = 1 (Very Much Improved) - 7 (Very Much Worse) Lower scores represent more improvement.
Outcome measures
| Measure |
Cognitive Training
n=28 Participants
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
|
Non-progressive Cognitive Training
n=31 Participants
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
|
|---|---|---|
|
Clinical Global Impression - Improvement
|
3.28 units on a scale
Standard Deviation .81
|
3.32 units on a scale
Standard Deviation .79
|
SECONDARY outcome
Timeframe: 2 monthsStandard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task
Outcome measures
| Measure |
Cognitive Training
n=27 Participants
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
|
Non-progressive Cognitive Training
n=27 Participants
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
|
|---|---|---|
|
Intra-individual Variability on Go/No-Go Task
|
242.24 milliseconds
Standard Deviation 100.55
|
236.60 milliseconds
Standard Deviation 119.03
|
SECONDARY outcome
Timeframe: 2 monthsNumber of words read correctly divided by number of words read (range = 0-1.0) Higher values represent better reading accuracy
Outcome measures
| Measure |
Cognitive Training
n=29 Participants
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
|
Non-progressive Cognitive Training
n=32 Participants
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
|
|---|---|---|
|
Academic Improvement Measurement System - Web-based (AIMSWEB) Reading Score (Proportion Accurate)
|
.97 units on a scale
Standard Deviation .03
|
.97 units on a scale
Standard Deviation .04
|
Adverse Events
Cognitive Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-progressive Cognitive Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jeff Epstein
Cincinnati Children's Hospital Medical Center
Phone: 5136368296
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place