Trial Outcomes & Findings for Computerized Cognitive Rehabilitation in Ugandan Children With HIV (NCT NCT00926003)
NCT ID: NCT00926003
Last Updated: 2019-03-06
Results Overview
Kaufman Assessment Battery for Children, 2nd edition (KABC-II) Mental Processing Index (MPI), which is a global cognitive ability performance composite that is a standard score with a mean of 100 and a standard deviation of 15, with scores for our population of children typically ranging from 55 to 130. the MPI is comprised of the standardized global scores for the cognitive domains of Sequential Processing, Simultaneous Processing, Learning, and Planning. These standardized global domain scores are summed and converted (on the basis of age of child, using American norms) to a composite global performance measure called the Mental Processing Index (MPI) standard score (T score). Higher T scores indicate better performance and a better neuropsychological outcome.
COMPLETED
NA
159 participants
KABC-II MPI score at post-training 3 mo follow-up assessment, adjusted for baseline KABC-II MPI performance. Therefore, only a single score appears in the table.
2019-03-06
Participant Flow
159 school-age clinically stable children receiving monthly out-patient care at the Walter Reed Children's Clinic at the Kayunga District Hospital Kayunga town, Uganda.
Of 190 total available children at the study site, 159 were enrolled into the present clinical trial. 13 were ineligible due to profound neurocognitive disability or very poor health; 7 could not be reached; 7 lived outside of the study catchment area, and 4 declined to participate.
Participant milestones
| Measure |
CCRT Intervention
Computer Cognitive Rehabilitation Training Intervention 24 sessions over 8 weeks
Computerized cognitive rehabilitation therapy (CCRT): 8 weeks of 3 times weekly intervention for 45 min per session with Captain's Log program
|
Control
Passive Control with no intervention training for 8 weeks
|
Limited CCRT
Locked CCRT that does not become more difficult with mastery of child on computer games training
Limited CCRT active control intervention: Locked Captain's Log CCRT that rotates randomly among simplest level of computer cognitive games training
|
|---|---|---|---|
|
Baseline
STARTED
|
53
|
54
|
52
|
|
Baseline
COMPLETED
|
53
|
54
|
52
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
0
|
|
Post-Training Evaluation
STARTED
|
53
|
54
|
52
|
|
Post-Training Evaluation
COMPLETED
|
52
|
54
|
52
|
|
Post-Training Evaluation
NOT COMPLETED
|
1
|
0
|
0
|
|
Post-Training 3-month Follow-up
STARTED
|
52
|
54
|
52
|
|
Post-Training 3-month Follow-up
COMPLETED
|
51
|
54
|
52
|
|
Post-Training 3-month Follow-up
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
CCRT Intervention
Computer Cognitive Rehabilitation Training Intervention 24 sessions over 8 weeks
Computerized cognitive rehabilitation therapy (CCRT): 8 weeks of 3 times weekly intervention for 45 min per session with Captain's Log program
|
Control
Passive Control with no intervention training for 8 weeks
|
Limited CCRT
Locked CCRT that does not become more difficult with mastery of child on computer games training
Limited CCRT active control intervention: Locked Captain's Log CCRT that rotates randomly among simplest level of computer cognitive games training
|
|---|---|---|---|
|
Post-Training Evaluation
Withdrawal by Subject
|
1
|
0
|
0
|
|
Post-Training 3-month Follow-up
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Computerized Cognitive Rehabilitation in Ugandan Children With HIV
Baseline characteristics by cohort
| Measure |
CCRT Intervention
n=53 Participants
Computer Cognitive Rehabilitation Training Intervention 24 sessions over 8 weeks
Computerized cognitive rehabilitation therapy (CCRT): 8 weeks of 3 times weekly intervention for 45 min per session with Captain's Log program
|
Control
n=54 Participants
Passive Control with no intervention training for 8 weeks
|
Limited CCRT
n=52 Participants
Locked CCRT that does not become more difficult with mastery of child on computer games training
Limited CCRT active control intervention: Locked Captain's Log CCRT that rotates randomly among simplest level of computer cognitive games training
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
9.3 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
8.8 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
8.7 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
8.9 years
STANDARD_DEVIATION 1.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: KABC-II MPI score at post-training 3 mo follow-up assessment, adjusted for baseline KABC-II MPI performance. Therefore, only a single score appears in the table.Kaufman Assessment Battery for Children, 2nd edition (KABC-II) Mental Processing Index (MPI), which is a global cognitive ability performance composite that is a standard score with a mean of 100 and a standard deviation of 15, with scores for our population of children typically ranging from 55 to 130. the MPI is comprised of the standardized global scores for the cognitive domains of Sequential Processing, Simultaneous Processing, Learning, and Planning. These standardized global domain scores are summed and converted (on the basis of age of child, using American norms) to a composite global performance measure called the Mental Processing Index (MPI) standard score (T score). Higher T scores indicate better performance and a better neuropsychological outcome.
Outcome measures
| Measure |
CCRT Intervention
n=53 Participants
Computer Cognitive Rehabilitation Training Intervention 24 sessions over 8 weeks
Computerized cognitive rehabilitation therapy (CCRT): 8 weeks of 3 times weekly intervention for 45 min per session with Captain's Log program
|
Control
n=54 Participants
Passive Control with no intervention training for 8 weeks
|
Limited CCRT
n=52 Participants
Locked CCRT that does not become more difficult with mastery of child on computer games training
Limited CCRT active control intervention: Locked Captain's Log CCRT that rotates randomly among simplest level of computer cognitive games training
|
|---|---|---|---|
|
Neuropsychological Performance (KABC2)
|
63.32 T scores from USA norms for this test
Standard Error 0.60
|
61.13 T scores from USA norms for this test
Standard Error 0.57
|
62.65 T scores from USA norms for this test
Standard Error 0.62
|
SECONDARY outcome
Timeframe: CBCL total score at post-training (3 months), adjusted by the baseline score, so that a single score appears in the results table.Population: 3-mo follow-up means adjusted for outcome at baseline, ARV treatment status
Child Behavior Checklist (CBCL) total score Total problems T-scores (standardized). This is a standardized score with a mean of 50 and a standard deviation of 10, with higher scores indicating more symptoms of either emotional (internalizing) or behavioral (externalizing) or other (e.g., sleep disturbances) nature. Range for our children on this scale is typically from 40 to 80. These are t scores based on Cross-Cultural norms, whereby higher scores (more symptoms or problems) indicate a worse outcome.
Outcome measures
| Measure |
CCRT Intervention
n=51 Participants
Computer Cognitive Rehabilitation Training Intervention 24 sessions over 8 weeks
Computerized cognitive rehabilitation therapy (CCRT): 8 weeks of 3 times weekly intervention for 45 min per session with Captain's Log program
|
Control
n=54 Participants
Passive Control with no intervention training for 8 weeks
|
Limited CCRT
n=52 Participants
Locked CCRT that does not become more difficult with mastery of child on computer games training
Limited CCRT active control intervention: Locked Captain's Log CCRT that rotates randomly among simplest level of computer cognitive games training
|
|---|---|---|---|
|
Achenbach Child Behavior Checklist (CBCL) Total Score
|
55.61 T scores based on cross cultural norms
Standard Error 0.83
|
54.45 T scores based on cross cultural norms
Standard Error 0.78
|
53.46 T scores based on cross cultural norms
Standard Error 0.86
|
Adverse Events
CCRT Intervention
Control
Limited CCRT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place