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Life Skills Intervention for Adolescents Perinatally Infected With HIV

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ClinicalTrials.gov Identifier: NCT00272519
Recruitment Status : Completed
First Posted : January 6, 2006
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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The life skills intervention model is designed to help adolescents promote their physical and mental health through cognitive and behavioral techniques (e.g., problem solving, coping, and communication skills) designed to help them achieve social and personal competencies used to manage various life challenges.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Life Skills Intervention Not Applicable

Detailed Description:
One of the salient advantages of this intervention model is that it has been developed and implemented in several studies with adolescents. However, data concerning the effects of this model are much less extensive with adolescents perinatally infected with HIV. The proposed study is designed to address this gap in knowledge by conducting a pilot intervention tailoring the life skills intervention to the needs of young adolescents, perinatally infected with HIV, and to their primary caregivers. Given the emphasis on peer group interaction, the proposed intervention model also has the potential to reduce some of the social isolation imposed by the experiences related to HIV infection by creating opportunities for adolescents to interact with others who are managing comparable stressors and treatment regimens.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Life Skills Intervention for Young Adolescents Perinatally Infected With HIV and Their Caregivers
Study Start Date : June 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Adolescent/caregiver dyads
Eight to ten adolescent/caregiver dyads
 Behavioral: Life Skills Intervention
Developed to promote life skills among young adolescents perinatally infected with HIV
Other Name: No other names.


Outcome Measures
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Primary Outcome Measures :
  1. Implement and evaluate the feasibility and acceptability of a modified life skills intervention [ Time Frame: 1 year ]
    To implement and evaluate the feasibility and acceptability of a modified life skills intervention for young adolescents with perinatally acquired HIV infection and their primary caregivers.


Secondary Outcome Measures :
  1. Evaluate the feasibility and acceptability of an assessment battery [ Time Frame: 1 year ]
    To evaluate the feasibility and acceptability of an assessment battery with young adolescents with perinatally acquired HIV infection and their primary caregivers when implemented at baseline, post-intervention and 4-month follow-up.


Eligibility Criteria
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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically-identified HIV-1 infected participants 11-14 years of age and their primary caregivers.
  • HIV status has been disclosed to the adolescent.
  • Caregiver is the legal guardian of the adolescent as indicated by the medical team.
  • Adolescent lives with the caregiver
  • Adolescent and caregiver speak and understand English.

Exclusion Criteria:

  • Caregiver consent or permission denied or adolescent does not assent.
  • Adolescent diagnosed as mentally retarded as previously reported or confirmed through chart review.
  • Adolescent and/or caregiver too medically fragile. Medically fragile is functionally defined as being physically unable to attend the group.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272519


Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Study Chair: Ahna Pai, Ph.D Children's Hospital of Philadelphia
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Website for the Adolescent Trials Network for HIV/AIDS Interventions  This link exits the ClinicalTrials.gov site

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00272519     History of Changes
Other Study ID Numbers: ATN 045b
First Posted: January 6, 2006    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2016

Keywords provided by University of North Carolina, Chapel Hill:
HIV
AIDS
Adolescent
HIV Positive

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