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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100331
• Other study ID #: 2016-299
• Status: Completed
• Phase: N/A
• Start date: January 13, 2017
• Est. completion date: June 2021

Study information

• Verified date: May 2023
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

• Perinatally infected with HIV, internationally adopted

Exclusion Criteria:

• Prior neuropsychological testing

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Other:
• Neuropsychological testing
Comprehensive neuropsychological assessment and implementation of appropriate support and resources.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health Hospitals

Outcome

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