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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00224900
Recruitment Status : Terminated
First Posted : September 23, 2005
Last Update Posted : February 28, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date September 21, 2005
First Posted Date September 23, 2005
Last Update Posted Date February 28, 2017
Study Start Date September 2005
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development of a Life Skills Intervention for Young Adolescents Perinatally-Infected With HIV and Their Caregivers
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
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Young adolescents perinatally infected with HIV, 11 to 14 years of age and their caregivers.
Condition HIV Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: September¬†21,¬†2005)
10
Original Enrollment Same as current
Actual Study Completion Date May 2006
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 11 Years to 16 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00224900
Other Study ID Numbers ATN 045a
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor University of North Carolina, Chapel Hill
Collaborators
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Study Chair: Ahna L Hoff, Ph.D. Case Western Reserve University School of Medicine and Rainbow Babies and Childrens Hospital
PRS Account University of North Carolina, Chapel Hill
Verification Date February 2016