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

NCT03100331 | Completed

• 1 other identifier: 2016-299
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV/AIDS

Keywords

neuropsychological outcomes; HIV/AIDS; international adoption; perinatal infection

Outcome Measures

Primary Outcomes (13)

• Change in Rating scales of behavioral and social/emotional functioning

  Parental reporting

  24-36 months

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

  24-36 months

• Change in Score of Wechsler Individual Achievement Test - Third Edition

  24-36 months

• Change in Score of Gordon Diagnostic System

  24-36 months

• Change in Score of Grooved Pegboard

  24-36 months

• Change in Score of Token Test for Children - Second Edition

  24-36 months

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

  24-36 months

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

  24-36 months

• Change in Score of Rey-Osterrieth Complex Figure Test

  24-36 months

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

  24-36 months

• Change in Score of Peabody Picture Vocabulary Test - Fourth Edition

  24-36 months

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

  24-36 months

• Change in Score of Pediatric Sleep Questionnaire

  24-36 months

Study Arms (1)

Single Arm; all receive neuropsychological testing & follow-up

EXPERIMENTAL

Other: Neuropsychological testing

Interventions

Neuropsychological testing OTHER

Comprehensive neuropsychological assessment and implementation of appropriate support and resources.

Single Arm; all receive neuropsychological testing & follow-up

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Perinatally infected with HIV, internationally adopted

You may not qualify if:

• Prior neuropsychological testing

Sponsors & Collaborators

• Corewell Health West: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 4, 2017
• Study Start: January 13, 2017
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share