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

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neuropsychological testing
Sponsored by
Spectrum Health Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS focused on measuring neuropsychological outcomes, HIV/AIDS, international adoption, perinatal infection

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Perinatally infected with HIV, internationally adopted

Exclusion Criteria:

  • Prior neuropsychological testing

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single Arm; all receive neuropsychological testing & follow-up

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 20, 2017
    Last Updated
    May 31, 2023
    Sponsor
    Spectrum Health Hospitals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03100331
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 13, 2017 (Actual)
    Primary Completion Date
    June 2021 (Actual)
    Study Completion Date
    June 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Spectrum Health Hospitals

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV/AIDS
    Keywords
    neuropsychological outcomes, HIV/AIDS, international adoption, perinatal infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Arm; all receive neuropsychological testing & follow-up
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Neuropsychological testing
    Intervention Description
    Comprehensive neuropsychological assessment and implementation of appropriate support and resources.
    Primary Outcome Measure Information:
    Title
    Change in Rating scales of behavioral and social/emotional functioning
    Description
    Parental reporting
    Time Frame
    24-36 months
    Title
    Change in Score of Wechsler Intelligence Scale for Children - Fifth Edition
    Time Frame
    24-36 months
    Title
    Change in Score of Wechsler Individual Achievement Test - Third Edition
    Time Frame
    24-36 months
    Title
    Change in Score of Gordon Diagnostic System
    Time Frame
    24-36 months
    Title
    Change in Score of Grooved Pegboard
    Time Frame
    24-36 months
    Title
    Change in Score of Token Test for Children - Second Edition
    Time Frame
    24-36 months
    Title
    Change in Score of Wide Range Assessment of Memory and Learning - Second Edition
    Time Frame
    24-36 months
    Title
    Change in Score of Delis Kaplan Executive Function System: Selected Subtests
    Time Frame
    24-36 months
    Title
    Change in Score of Rey-Osterrieth Complex Figure Test
    Time Frame
    24-36 months
    Title
    Change in Score of Beery-Buktenica Developmental Test of Visual Motor Integration - Sixth Edition
    Time Frame
    24-36 months
    Title
    Change in Score of Peabody Picture Vocabulary Test - Fourth Edition
    Time Frame
    24-36 months
    Title
    Change in Score of Behavior Assessment System for Children - Second Edition: Self, Parent, and Teacher Reports
    Time Frame
    24-36 months
    Title
    Change in Score of Pediatric Sleep Questionnaire
    Time Frame
    24-36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Perinatally infected with HIV, internationally adopted Exclusion Criteria: Prior neuropsychological testing

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    We may share the data with future co-investigators at the NIH Peds HIV observational cohort study

    Learn more about this trial

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

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