Computerized Cognitive Rehabilitation in Ugandan Children With HIV

NCT00926003 | Completed Results

• 2 other identifiers: BIRB 07-709R34MH085631
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

One-hundred and fifty-nine school-age children with HIV in Kayunga District, Uganda were randomized to one of 3 treatment arms: 24 training sessions of a computerized cognitive rehabilitation therapy (CCRT) program called Captain's Log; 24 sessions of Captain's Log not titrated to child's performance; or no training intervention. Study Aim 1: To compare the neuropsychological benefit of 24 training sessions of Captain's Log CCRT to the active and passive control groups over a 8-week period, and at 3-month follow-up. Study Aim 2: To compare the psychiatric benefit of 24 training sessions of Captain's Log CCRT to the active and passive control groups over an 8-week period, and at 3-month follow-up. Study Aim 3: To evaluate how ART treatment status, and the corresponding clinical stability of the child modifies CCRT neuropsychological performance gains and psychiatric symptom reduction. Outcome Assessments: The Kaufman Assessment Battery for Children, 2nd ed. (KABC-2), Tests of Variables of Attention (TOVA) visual and auditory tests, CogState computerized neuropsychological screening test, Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), and Achenbach Child Behavior Checklist (CBCL) will be administered before and after the 8-week training period and at 3-month follow-up post training. Captain's Log has an internal evaluator feature which will help us monitor the specific training tasks to which the children best respond. Analyses: We will compare neuropsychological and psychiatric gains over the 8-week training period and at 3-mo follow-up for our three study groups, anticipating that they will be significantly greater for the CCRT intervention children (Study Aims 1 \& 2). These neuropsychological gains will be associated with improved school performance over the long-term. Intervention children clinically stable on ART will have greater gains than those not stable or virally suppressed on ART. Conclusion: CCRT will prove effective and sustainable for enhancing neurocognitive status in HIV children. Futher work will prove this approach viable for assessing and treating children in resource-poor settings.

Conditions

HIV Infections

Keywords

HIV; Children; Africa; Neuropsychology; cognitive rehabilitation; computers

Outcome Measures

Primary Outcomes (1)

• Neuropsychological Performance (KABC2)

  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.

  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.

Secondary Outcomes (1)

• Achenbach Child Behavior Checklist (CBCL) Total Score

  CBCL total score at post-training (3 months), adjusted by the baseline score, so that a single score appears in the results table.

Study Arms (3)

Full Computerized Cognitive Training

EXPERIMENTAL

Intervention is a Computer Cognitive Rehabilitation Training delivered in 24 sessions over 8 weeks (3 times/week). A training session lasts about an hour and consists of 9 training games or programs, 3 pertaining to improving attention, 3 pertaining to improving visual-spatial memory, and 3 pertaining to improving reasoning/planning. Each training game become more difficult as the child gains proficiency.

Behavioral: Full Computerized cognitive training

Control

NO INTERVENTION

Passive Control with no intervention training (computer cognitive games) for 8 weeks.

Limited computerized cognitive training

ACTIVE COMPARATOR

Intervention is a Computer Cognitive Rehabilitation Training delivered in 24 sessions over 8 weeks (3 times/week). A training session lasts about an hour and consists of 9 training games or programs, 3 pertaining to improving attention, 3 pertaining to improving visual-spatial memory, and 3 pertaining to improving reasoning/planning. In this arm, however, the training games do NOT become progressively more difficult as the child gains proficiency, but rotates randomly among simpler to moderate levels of difficulty for each game. The purpose to to give children int he "limited" CCRT arm comparable exposure to the cognitive games training as with the "full CCRT" arm, with the exception of the titrating nature of the game training.

Behavioral: Limited computerized cognitive training

Interventions

Full Computerized cognitive training BEHAVIORAL

8 weeks of 3 times weekly intervention for 60 min per session with the full titrating version of Captain's Log program (3 games for attention, 3 games for visual spatial working memory, 3 games for reasoning/planning

Also known as: computerized cognitive games, computerized cognitive rehabilitation therapy (CCRT)

Full Computerized Cognitive Training

Limited computerized cognitive training BEHAVIORAL

Locked Captain's Log CCRT that rotates randomly among simplest level of computer cognitive games training. 8 weeks of 3 times weekly intervention for 60 min per session with the non-titrating version of Captain's Log program (3 games for attention, 3 games for visual spatial working memory, 3 games for reasoning/planning).

Also known as: computerized cognitive rehabilitation therapy (CCRT)

Limited computerized cognitive training

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• HIV children 6 to 16 years of age and enrolled in the CAI program will be eligible should the parent or caregiver consent to participation in the study. They will all be confirmed HIV positive children (ELISA and Western blot). Only children with perinatally acquired HIV infection will be included.

You may not qualify if:

• At pre-CCRT medical examination (see medical exam form in appendices) we will exclude children with a medical history of serious birth complications, severe malnutrition, bacterial meningitis, encephalitis, cerebral malaria, or other known brain injury or disorder requiring hospitalization. Also children with seizure or other neurological disability will be excluded. This will be screened using a brief medical history questionnaire and CAI medical chart review.

Sponsors & Collaborators

• Michigan State University: lead
• Global Health Uganda LTD: collaborator
• University of Michigan: collaborator

Study Sites (1)

Global Health Uganda

Kampala, Uganda

Location

Related Publications (3)

• Ruisenor-Escudero H, Familiar I, Nakasujja N, Bangirana P, Opoka R, Giordani B, Boivin M. Immunological correlates of behavioral problems in school-aged children living with HIV in Kayunga, Uganda. Glob Ment Health (Camb). 2015 Jun 25;2:e9. doi: 10.1017/gmh.2015.7. eCollection 2015.

  PMID: 28596857 RESULT

• Giordani B, Novak B, Sikorskii A, Bangirana P, Nakasujja N, Winn BM, Boivin MJ. Designing and evaluating Brain Powered Games for cognitive training and rehabilitation in at-risk African children. Glob Ment Health (Camb). 2015 May 29;2:e6. doi: 10.1017/gmh.2015.5. eCollection 2015.

  PMID: 28596854 RESULT

• Boivin MJ, Nakasujja N, Sikorskii A, Opoka RO, Giordani B. A Randomized Controlled Trial to Evaluate if Computerized Cognitive Rehabilitation Improves Neurocognition in Ugandan Children with HIV. AIDS Res Hum Retroviruses. 2016 Aug;32(8):743-55. doi: 10.1089/AID.2016.0026. Epub 2016 May 2.

  PMID: 27045714 RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Michael J. Boivin
• Organization: Michigan State University

Michael.Boivin@hc.msu.edu

5174324204

Study Officials

• Michael J. Boivin, PhD, MPH

  MSU Psychiatry

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Neurology & Ophthalmology

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 23, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 6, 2019
• Results First Posted: March 6, 2019

Record last verified: 2019-03

Locations

UG (1)