Development of a Life Skills Intervention for Young Adolescents Perinatally-Infected With HIV and Their Caregivers



Status:Terminated
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:11 - 16
Updated:3/1/2017
Start Date:September 2005
End Date:May 2006

Use our guide to learn which trials are right for you!

Development of a Life Skills Intervention for Young Adolescents Perinatally-Infected With HIV and Their Caregivers Part A: Focus Group And Measurement Evaluation

During this phase of the study, a focus group will be conducted with young adolescents
perinatally infected with HIV and with their caregivers to develop and evaluate the content
of the proposed intervention. The purpose of the focus groups is to identify key issues and
challenges that often face young adolescents perinatally infected with HIV and their
caregivers as well as to elicit suggestions to enhance the feasibility and acceptability of
the proposed intervention. The focus groups will be audio recorded and transcribed and
reviewed by all involved in future protocol development. Themes will be pulled directly from
the focus groups to guide examples and areas of emphasis in the intervention. In addition,
proposed measures will be administered to the adolescents and their caregivers and assessed
for appropriateness for this population.

This study is designed to collect information from HIV-1 perinatally infected adolescents
for the development of a pilot study that will use a life skills intervention model. One
focus group comprised of adolescents and one focus group comprised of their caregivers will
use a series of open-ended questions to facilitate a group discussion to define the life
skills intervention model. Ten young adolescents, ages 11 to 14 years, and their caregivers
will participate in these focus groups at Rainbow Babies and Children's Hospital in
Cleveland, Ohio. The protocol will be site-restricted for participation. The responses from
the focus group will be used to tailor the proposed life skills intervention model and to
provide a detailed description of intervention content including: common peer issues of
young adolescents perinatally infected with HIV, typical sexual knowledge and behaviors,
typical areas of conflict between adolescents and caregivers, and common ways of managing
conflict. In addition, those that participate in the focus group will be asked to complete a
series of questionnaires in order to assess the appropriateness of the proposed measurement
battery for adolescents perinatally infected with HIV and their caregivers.

Findings from this study (ATN 045- Part A) will be used in the development of a proposal for
a pilot study of the life skills intervention model (ATN 045-Part B). The pilot study will
examine the feasibility of successfully providing a life skills intervention to HIV-1
infected young adolescents at an ATN clinical site, the acceptability of such an
intervention in young adolescents, as well as the logistics of providing such an
intervention.

Inclusion Criteria:

- Clinically-identified HIV-1 infected subjects 11-14 years of age and their
caregivers.

- HIV status has been disclosed to the adolescent.

- HIV-1 infection transmission due to perinatal infection as identified by treating
physician.

- Caregiver is legal guardian of the adolescent as indicated by the medical team in the
clinic from which recruitment will be conducted.

- Adolescent lives with the caregiver.

- Adolescent and caregiver speak English.

Exclusion Criteria:

- Caregiver permission denied or adolescent does not assent.

- Adolescent previously diagnosed as mentally retarded as reported by caregiver through
school and/or other psychological testing.

- Adolescent and/or caregiver too medically fragile. Medically fragile is functionally
defined as being physically unable to attend the group.
We found this trial at
1
site
10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials