Clinical trial NCT03100331: Neuropsychological Outcomes of Internationally-Adopted Children Who Are Perinatally-Infected With Human Immunodeficiency Virus
Official title: Neuropsychological Outcomes of Internationally-Adopted Children Who Are Perinatally-Infected With Human Immunodeficiency Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: neuropsychological outcomes
HIV/AIDS
international adoption
perinatal infection
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 17
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Perinatally infected with HIV, internationally adopted

Exclusion Criteria:

* Prior neuropsychological testing

Primary outcomes:
measure: Change in Rating scales of behavioral and social/emotional functioning
timeFrame: 24-36 months
measure: Change in Score of Wechsler Intelligence Scale for Children - Fifth Edition
timeFrame: 24-36 months
measure: Change in Score of Wechsler Individual Achievement Test - Third Edition
timeFrame: 24-36 months
measure: Change in Score of Gordon Diagnostic System
timeFrame: 24-36 months
measure: Change in Score of Grooved Pegboard
timeFrame: 24-36 months
measure: Change in Score of Token Test for Children - Second Edition
timeFrame: 24-36 months
measure: Change in Score of Wide Range Assessment of Memory and Learning - Second Edition
timeFrame: 24-36 months
measure: Change in Score of Delis Kaplan Executive Function System: Selected Subtests
timeFrame: 24-36 months
measure: Change in Score of Rey-Osterrieth Complex Figure Test
timeFrame: 24-36 months
measure: Change in Score of Beery-Buktenica Developmental Test of Visual Motor Integration - Sixth Edition
timeFrame: 24-36 months
measure: Change in Score of Peabody Picture Vocabulary Test - Fourth Edition
timeFrame: 24-36 months
measure: Change in Score of Behavior Assessment System for Children - Second Edition: Self, Parent, and Teacher Reports
timeFrame: 24-36 months
measure: Change in Score of Pediatric Sleep Questionnaire
timeFrame: 24-36 months
Secondary outcomes:
Other outcomes:
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