Trial Outcomes & Findings for Development of a Multi-faceted Cognitive Training Program for Children With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT01352468)
NCT ID: NCT01352468
Last Updated: 2017-08-01
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
44 participants
Primary outcome timeframe
8 weeks
Results posted on
2017-08-01
Participant Flow
Participant milestones
| Measure |
Multifaceted Cognitive Training
Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.
Multifaceted cognitive training: Four computerized training tasks
|
Sham Cognitive Training
Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training
Multifaceted cognitive training: Four computerized training tasks
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of a Multi-faceted Cognitive Training Program for Children With Attention Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Multifaceted Cognitive Training
n=22 Participants
Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.
Multifaceted cognitive training: Four computerized training tasks
|
Sham Cognitive Training
n=22 Participants
Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training
Multifaceted cognitive training: Four computerized training tasks
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 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
|
9.05 years
STANDARD_DEVIATION 1.73 • n=5 Participants
|
9.22 years
STANDARD_DEVIATION 1.65 • n=7 Participants
|
9.14 years
STANDARD_DEVIATION 1.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 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
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksTotal 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 |
Multifaceted Cognitive Training
n=17 Participants
Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.
Multifaceted cognitive training: Four computerized training tasks
|
Sham Cognitive Training
n=18 Participants
Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training
Multifaceted cognitive training: Four computerized training tasks
|
|---|---|---|
|
Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale
|
25.94 units on a scale
Standard Deviation 8.95
|
28.28 units on a scale
Standard Deviation 8.21
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Go/No-Go task data was not available for one participant in the Sham Cognitive Training condition
Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task
Outcome measures
| Measure |
Multifaceted Cognitive Training
n=17 Participants
Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.
Multifaceted cognitive training: Four computerized training tasks
|
Sham Cognitive Training
n=17 Participants
Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training
Multifaceted cognitive training: Four computerized training tasks
|
|---|---|---|
|
Reaction Time Variability on go/No-go Task
|
182.51 milliseconds
Standard Deviation 96.12
|
160.25 milliseconds
Standard Deviation 95.82
|
SECONDARY outcome
Timeframe: 8 weeksNumber of words read correctly divided by number of words read
Outcome measures
| Measure |
Multifaceted Cognitive Training
n=17 Participants
Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.
Multifaceted cognitive training: Four computerized training tasks
|
Sham Cognitive Training
n=18 Participants
Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training
Multifaceted cognitive training: Four computerized training tasks
|
|---|---|---|
|
Proportion of Words Read Accurately Using the AIMSWEB
|
.98 proportion of words read accurately
Standard Deviation .01
|
.98 proportion of words read accurately
Standard Deviation .02
|
Adverse Events
Multifaceted Cognitive Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham 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