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

This study has been terminated.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00224900
First received: September 21, 2005
Last updated: October 8, 2013
Last verified: August 2013
  Purpose

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.


Condition
HIV Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Development of a Life Skills Intervention for Young Adolescents Perinatally-Infected With HIV and Their Caregivers Part A: Focus Group And Measurement Evaluation

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Enrollment: 10
Study Start Date: September 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Young adolescents perinatally infected with HIV, 11 to 14 years of age and their caregivers.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224900

Locations
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Investigators
Study Chair: Ahna L Hoff, Ph.D. Case Western Reserve University School of Medicine and Rainbow Babies and Childrens Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00224900     History of Changes
Other Study ID Numbers: ATN 045a
Study First Received: September 21, 2005
Last Updated: October 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Perinatally-acquired HIV infection
Life Skills
Focus Group
Young adolescents
Caregivers

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 23, 2014