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临床试验/NCT03100331
NCT03100331已完成不适用

Neuropsychological Outcomes of Internationally-Adopted Children Who Are Perinatally-Infected With Human Immunodeficiency Virus

Spectrum Health Hospitals0 个研究点目标入组 17 人开始时间: 2017年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
主要终点
Change in Score of Gordon Diagnostic System

研究概览

简要总结

Children who are perinatally-infected with HIV are extremely vulnerable to cognitive delays and psychiatric disease, and the risk for neuropsychiatric illness is compounded in children who are internationally-adopted and may have suffered trauma, abandonment, malnutrition and neglect. While cognitive and psychiatric issues have been described in HIV-infected children, and even more so in HIV-positive adults, there have been no reports on neuropsychiatric interventions that can improve cognitive and psychiatric states in this highly vulnerable population. Without these needed data, Pediatric HIV providers have not been able to advocate for optimal neuropsychiatric care in perinatally HIV-infected children, let alone those who has suffered the additional risk of being internationally adopted. In the proposed study, the investigators will report on the neuropsychological profiles and outcomes in a cohort of internationally-adopted, perinatally HIV-infected children between ages 6 to 16 years who have not previously undergone neuropsychological testing or treatment. Data obtained from this study will provide important contributions to the literature by building understanding of the complex needs of this population as well as guiding future intervention efforts. The investigators predict that intervention efforts aimed at helping educators understand the learning and cognitive challenges for many of our patients will guide targeted academic supports in the school setting and lead to gains in academic skills. The detailed information obtained during the comprehensive neuropsychological assessment and follow-up care will be shared with the child's key educators at school so that individualized educational strategies can be developed, while maintaining confidentiality regarding the child's HIV status.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Perinatally infected with HIV, internationally adopted

排除标准

  • Prior neuropsychological testing

结局指标

主要结局

Change in Score of Gordon Diagnostic System

时间窗: 24-36 months

Change in Score of Token Test for Children - Second Edition

时间窗: 24-36 months

Change in Score of Rey-Osterrieth Complex Figure Test

时间窗: 24-36 months

Change in Score of Grooved Pegboard

时间窗: 24-36 months

Change in Score of Wide Range Assessment of Memory and Learning - Second Edition

时间窗: 24-36 months

Change in Score of Wechsler Intelligence Scale for Children - Fifth Edition

时间窗: 24-36 months

Change in Score of Wechsler Individual Achievement Test - Third Edition

时间窗: 24-36 months

Change in Rating scales of behavioral and social/emotional functioning

时间窗: 24-36 months

Parental reporting

Change in Score of Delis Kaplan Executive Function System: Selected Subtests

时间窗: 24-36 months

Change in Score of Beery-Buktenica Developmental Test of Visual Motor Integration - Sixth Edition

时间窗: 24-36 months

Change in Score of Behavior Assessment System for Children - Second Edition: Self, Parent, and Teacher Reports

时间窗: 24-36 months

Change in Score of Pediatric Sleep Questionnaire

时间窗: 24-36 months

Change in Score of Peabody Picture Vocabulary Test - Fourth Edition

时间窗: 24-36 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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