AzTrials
AzTrials

Acquired Immunodeficiency SyndromeNCT00001435

Psychosocial Correlates and Coping Strategies Associated With Long-Term Survival of HIV-Infected Children

An observational study of Acquired Immunodeficiency Syndrome and Depressive Disorder, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
How many people
110 participants
Where
1 siteUnited States
Study dates
Apr 1995to Dec 2000
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Cancer Institute (NCI)

    Bethesda, Maryland, 20892

Other trials in United States

About this study

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.

Read the detailed description

Children and adolescents with HIV/AIDS are living well beyond the 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 will examine the psychosocial factors and adaptive coping strategies associated with long-term survival of HIV/AIDS and how these factors change over a period of three years. In addition, data will be collected from the primary caretakers on both their own and their perceptions of their child's adjustment and coping. Subjects will include children who have been infected (either perinatally or through transfusion) for at least eight years and who are aware of their diagnosis.

Studies of children with chronic illnesses report that adaptive coping strategies such as maintaining a hopeful attitude, social support and information seeking may affect psychological adjustment and help to buffer the negative psychological effects that a chronic illness may have. HIV-infected children not only have the added stress of living with debilitating and progressive symptoms in a disease that threatens their life spans, but their disease often stigmatizes them and causes them to be ostracized. The largest proportion of children with HIV disease acquired it perinatally, and therefore the mother is also infected. Thus it is expected that these families have at least two infected natural family members, causing multigenerational effect in terms of epidemiology, multiple separations and the death of close family members. As a result, children need to develop coping strategies in order to deal effectively with this disease.

Preliminary results from a longitudinal study assessing psychiatric disturbances in HIV-infected, school-aged children indicate that these children exhibit elevated levels of separation anxiety, depression and overanxious disorder. Whether similar results will be found in older HIV-infected children is not yet known. Research that can identify the coping resources, such as social support, family communication styles, hopefulness and quality of life, that 1) buffer the negative effects of stress on the mental health of HIV-infected children and 2) identify areas of vulnerability, would be important in our attempts to design early mental health interventions.

The HIV-infected child's perceived social support, self-esteem, psychological adjustment, and adaptive coping will be based on self-reports from the child. The caretakers will also give ratings of the child's adjustment in addition to providing information on how they feel their child has changed in the past year. Caretakers will complete measures regarding family environment, their own adjustment, and demographic variables. The child's health care provider will complete a questionnaire assessing his/her current health status. The effects of age and disease progression in both the child and parent will be taken into account for the final analysis of this study.

Keywords
Anxiety, Depression, Family Functioning, Psychosocial Adjustment, Social Support
Medical subject headings
Acquired Immunodeficiency Syndrome, Depressive Disorder, HIV Infections, Anxiety Disorders, Depression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2002 (estimated)
  2. Study startApr 1995
  3. Study completionDec 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
110 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001435
Sponsor's protocol ID
950112
Other IDs
95-C-0112
Status last verified
Feb 2000
First submitted
3 Nov 1999
Last updated
4 Mar 2008
Results posted
No

Publications

  • 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.

    PubMed 8063915
  • 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.

    PubMed 7520454
  • 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.

    PubMed 7977671

Questions about this trial

What is this clinical trial studying?

An observational study of Acquired Immunodeficiency Syndrome and Depressive Disorder, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001435, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in