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Completed

NCT Number: NCT03100331

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

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Perinatally infected with HIV, internationally adopted

Exclusion criteria

  • Prior neuropsychological testing

Treatment and study plan

Neuropsychological Testing

Other

Comprehensive neuropsychological assessment and implementation of appropriate support and resources.

Primary outcomes

  1. Change in Rating scales of behavioral and social/emotional functioning

    Time frame: 24-36 months

    Parental reporting

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

    Time frame: 24-36 months

  3. Change in Score of Wechsler Individual Achievement Test - Third Edition

    Time frame: 24-36 months

  4. Change in Score of Gordon Diagnostic System

    Time frame: 24-36 months

  5. Change in Score of Grooved Pegboard

    Time frame: 24-36 months

  6. Change in Score of Token Test for Children - Second Edition

    Time frame: 24-36 months

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

    Time frame: 24-36 months

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

    Time frame: 24-36 months

  9. Change in Score of Rey-Osterrieth Complex Figure Test

    Time frame: 24-36 months

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

    Time frame: 24-36 months

  11. Change in Score of Peabody Picture Vocabulary Test - Fourth Edition

    Time frame: 24-36 months

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

    Time frame: 24-36 months

  13. Change in Score of Pediatric Sleep Questionnaire

    Time frame: 24-36 months

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 4, 2017
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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