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
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
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
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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