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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00926003
Computerized Cognitive Rehabilitation in Ugandan Children With HIV
Neuropsychological Benefits of Cognitive Training in Ugandan HIV Children
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Aim 1. To evaluate the effectiveness of CCRT in improving cognitive performance outcomes in Ugandan children with HIV.
Hypothesis 1a: CCRT can improve short and long-term cognitive outcomes in children with HIV; Hypothesis 1b: Improvements in performance associated with CCRT are not solely due to increased computer exposure.
One-hundred and fifty school-age children with HIV in Kayunga District, Uganda, will undergo baseline neuropsychological testing using the Kaufman Assessment Battery for Children (KABC-2), the computerized Tests of Variables of Attention (TOVA: auditory and visual tests), the brief CogState computerized neuropsychological test battery (CogState), and the Bruininks-Oseretsky Tests of Motor Proficiency (2nd edition) (BOT-2). Cogstate is designed as a neuropsychological screening tool with minimal practice effects and suitable in a repeated measures design for monitoring the benefits of treatment on neurocognitive disability11. Children then will be randomized to either: CCRT intervention group (Captain's Log active rehabilitation), active control group (Captain's Log locked, non-rehabilitation mode), or passive control group (no computer intervention). CCRT or computer controls will be presented over 24 sessions (~ 45 min) for 8 weeks (3 sessions per week). After the 8-weeks, neurocognitive gains will be assessed with CogState and the KABC-2 working memory subscales (primary expected outcome measures). The full KABC-2, TOVA, CogState, and BOT-2 will be re-administered 3 months after the 8-week assessment. Thus, the full battery will be administered at enrollment and at 3-month follow-up, while the most strategic portions of the battery will be administered following the 8 weeks CCRT intervention period. The combined testing will allow us to assess both the short-term and longer-term neuropsychological benefits of CCRT.
Aim 2. To evaluate the effectiveness of CCRT in reducing psychiatric symptoms in Ugandan children with HIV.
Hypothesis 2: CCRT can reduce short- and long-term psychiatric symptoms in children with HIV.
Previously in cerebral malaria survivors, we demonstrated a significant reduction in short-term symptoms related to anxiety, depression, and somatic complaints as assessed by the Achenbach Child Behavior Checklist (CBCL) following CCRT intervention12. In this aim, caregiver-reported psychiatric symptoms on the CBCL will be assessed at enrollment, after the 8-week CCRT intervention period, and 3 months after enrollment. The CBCL assessment will also help us gauge the psychosocial benefits of the social attention and enrichment surrounding computer exposure in the active control condition, rather than the rehabilitative aspects of CCRT per se. This will be evident as we compare the active and passive control groups.
Aim 3. To evaluate how ARV treatment status and clinical response along with corresponding immunological status of the child modifies CCRT neuropsychological performance gains and psychiatric symptom reduction; .after controlling for quality of home environment, nutrition, and other risk factors of poverty.
Hypothesis 3: Children virally suppressed on ART treatment with a history of fewer opportunistic illnesses and better CD4 counts will have better neuropsychological outcomes in response to CCRT training.The moderating effects of HIV progressive encephalopathy on brain plasticity can also be monitored by CCRT training progress, measures by the Captain's Log Internal Evaluator (CLIE) feature of the CCRT program.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kampala, Uganda
- Global Health Uganda
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Full Computerized Cognitive Training
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.
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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
Otros nombres:
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Sin intervención: Control
Passive Control with no intervention training (computer cognitive games) for 8 weeks.
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Comparador activo: Limited computerized cognitive training
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.
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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).
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Neuropsychological Performance (KABC2)
Periodo de tiempo: 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.
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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.
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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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Achenbach Child Behavior Checklist (CBCL) Total Score
Periodo de tiempo: CBCL total score at post-training (3 months), adjusted by the baseline score, so that a single score appears in the results table.
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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.
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CBCL total score at post-training (3 months), adjusted by the baseline score, so that a single score appears in the results table.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Michael J. Boivin, PhD, MPH, MSU Psychiatry
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Infecciones por VIH
Otros números de identificación del estudio
- BIRB 07-709
- R34MH085631 (Otro número de subvención/financiamiento: National Institute of Health)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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