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Computerized Cognitive Rehabilitation in Ugandan Children With HIV

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ClinicalTrials.gov Identifier: NCT00926003
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
Global Health Uganda
University of Michigan
Information provided by (Responsible Party):
Michael J. Boivin, Michigan State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Behavioral: Full Computerized cognitive training
Behavioral: Limited computerized cognitive training
Enrollment 159
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title CCRT Intervention Control Limited CCRT
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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

Passive Control with no intervention training for 8 weeks

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

Period Title: Baseline
Started 53 54 52
Completed 53 54 52
Not Completed 0 0 0
Period Title: Post-Training Evaluation
Started 53 54 52
Completed 52 54 52
Not Completed 1 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0
Period Title: Post-Training 3-month Follow-up
Started 52 54 52
Completed 51 54 52
Not Completed 1 0 0
Reason Not Completed
Lost to Follow-up             1             0             0
Arm/Group Title CCRT Intervention Control Limited CCRT Total
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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

Passive Control with no intervention training for 8 weeks

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 of all reporting groups
Overall Number of Baseline Participants 53 54 52 159
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 54 participants 52 participants 159 participants
9.3  (1.7) 8.8  (1.9) 8.7  (2.0) 8.9  (1.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 54 participants 52 participants 159 participants
Female
24
  45.3%
27
  50.0%
30
  57.7%
81
  50.9%
Male
29
  54.7%
27
  50.0%
22
  42.3%
78
  49.1%
1.Primary Outcome
Title Neuropsychological Performance (KABC2)
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CCRT Intervention Control Limited CCRT
Hide Arm/Group Description:

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

Passive Control with no intervention training for 8 weeks

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

Overall Number of Participants Analyzed 53 54 52
Mean (Standard Error)
Unit of Measure: T scores from USA norms for this test
63.32  (0.60) 61.13  (0.57) 62.65  (0.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CCRT Intervention, Control, Limited CCRT
Comments Least Square Means from Longitudinal Model, Their Standard Errors by Trial Arm Adjusted for Age, Being on ART at Intake, Socioeconomic Score, Home Score, Recruitment Location, KABC Learning and Delayed Recall Scores at Baseline, and Outcome Score at Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Achenbach Child Behavior Checklist (CBCL) Total Score
Hide Description 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.
Time Frame CBCL total score at post-training (3 months), adjusted by the baseline score, so that a single score appears in the results table.
Hide Outcome Measure Data
Hide Analysis Population Description
3-mo follow-up means adjusted for outcome at baseline, ARV treatment status
Arm/Group Title CCRT Intervention Control Limited CCRT
Hide Arm/Group Description:

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

Passive Control with no intervention training for 8 weeks

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

Overall Number of Participants Analyzed 51 54 52
Mean (Standard Error)
Unit of Measure: T scores based on cross cultural norms
55.61  (0.83) 54.45  (0.78) 53.46  (0.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CCRT Intervention, Control, Limited CCRT
Comments Least Square Means from Longitudinal Model, Their Standard Errors by Trial Arm Adjusted for Age, Being on ARV at Intake, Socioeconomic Score, Home Score, Recruitment Location, KABC Learning and Delayed Recall Scores at Baseline, and Outcome Score at Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description Adverse events were in surveillance during entire study time period
 
Arm/Group Title CCRT Intervention Control Limited CCRT
Hide Arm/Group Description

Intervention is a Computer Cognitive Rehabilitation Training delivered in 24 sessions over 8 weeks (3 times/week)

Computerized cognitive rehabilitation therapy (CCRT): 8 weeks of 3 times weekly intervention for 45 min per session with Captain's Log program

Passive Control with no intervention training for 8 weeks

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

All-Cause Mortality
CCRT Intervention Control Limited CCRT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/54 (0.00%)   0/52 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
CCRT Intervention Control Limited CCRT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/54 (0.00%)   0/52 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CCRT Intervention Control Limited CCRT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/54 (0.00%)   0/52 (0.00%) 
Uganda Ministry of Health mandated ARV treatment of all children with HIV part way through the trial. Future research should replicate our findings using CCRT with children with HIV already stabilized on ARV treatment and virally supporessed.
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
Layout table for Results Point of Contact information
Name/Title: Dr. Michael J. Boivin
Organization: Michigan State University
Phone: 5174324204
EMail: Michael.Boivin@hc.msu.edu
Layout table for additonal information
Responsible Party: Michael J. Boivin, Michigan State University
ClinicalTrials.gov Identifier: NCT00926003     History of Changes
Other Study ID Numbers: BIRB 07-709
R34MH085631 ( Other Grant/Funding Number: National Institute of Health )
First Submitted: June 22, 2009
First Posted: June 23, 2009
Results First Submitted: October 2, 2015
Results First Posted: March 6, 2019
Last Update Posted: March 6, 2019