NCT00001435

Brief Summary

Children and adolescents with HIV/AIDS are living well beyond life expectancy that was projected for them in the recent past. Little is known about the psychosocial variables that coincide with long-term survival of HIV/AIDS. This longitudinal study examines the psychosocial factors and adaptive coping strategies associated with long-term survival of HIV/AIDS in children and how these factors change over a period of two years. In addition, data is being collected from the primary caretakers on their own psychological well-being as will as their perceptions of their child's adjustment and coping. Participants include children who have been infected (either perinatally or through transfusion) for at least eight years and who were aware of their diagnosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 1995

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1995

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2000

Completed
2 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

February 1, 2000

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

AnxietyDepressionFamily FunctioningPsychosocial AdjustmentSocial Support

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
All children who have been infected, either vertically or through transfusion, for at least 8 years as of January 1, 1995 and who are enrolled in one of the HIV clinical protocols on the Pediatric Branch of the National Cancer Institute will be invited to participate in the study. The primary caregivers of the child will be asked to provide additional information about the family and themselves. Children who are unaware of their diagnosis will be excluded from the study as it would not be possible to ascertain their own perceptions as to how they have been coping with their disease. Children who are unable to understand and complete the measures being used due to cognitive deficits will not be administered those measures. This excludes all children whose current cognitive abilities fall 2 standard deviations or more below the normal range of cognitive functioning according to the Full Scale Intelligence Quotient (FSIQ). If a child's cognitive abilities fall below this criterion after the first data collections point (for example, if they become encephalopathic), we will not collect data from the child but we will continue to collect data from the caretaker. Care providers and children who cannot understand English will also be excluded from the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Bose S, Moss HA, Brouwers P, Pizzo P, Lorion R. Psychologic adjustment of human immunodeficiency virus-infected school-age children. J Dev Behav Pediatr. 1994 Jun;15(3 Suppl):S26-33.

    PMID: 8063915BACKGROUND
  • Havens JF, Whitaker AH, Feldman JF, Ehrhardt AA. Psychiatric morbidity in school-age children with congenital human immunodeficiency virus infection: a pilot study. J Dev Behav Pediatr. 1994 Jun;15(3 Suppl):S18-25.

    PMID: 7520454BACKGROUND
  • Wiener L, Theut S, Steinberg SM, Riekert KA, Pizzo PA. The HIV-infected child: parental responses and psychosocial implications. Am J Orthopsychiatry. 1994 Jul;64(3):485-92. doi: 10.1037/h0079539.

    PMID: 7977671BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeDepressive DisorderHIV InfectionsAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

April 1, 1995

Study Completion

December 1, 2000

Last Updated

March 4, 2008

Record last verified: 2000-02

Locations