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	Intervention	Phase
HIV Positive	Behavior: life skills	Phase IV

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

Primary Outcomes: 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 Outcomes: To evaluate the feasibility and acceptability of an assessment battery implemented at baseline, post-intervention and at a 4-month follow-up; for young adolescents with perinatally acquired HIV. infection and their primary caregivers.
Expected Total Enrollment:  40

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.

Ages Eligible for Study:  11 Years   -   14 Years,  Genders Eligible for Study:  Both

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00272519

Gayl Selkin-Gutman, MA      (301) 294-3872    gayleselkin-gutman@westat.com

Pennsylvania
      Children''''s Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States

Study chairs or principal investigators

Ahna Pai, Ph.D,  Study Chair,  Children''''s Hospital of Philadelphia   

Study ID Numbers:  ATN 045b
Last Updated:  January 5, 2006
Record first received:  January 3, 2006
ClinicalTrials.gov Identifier:  NCT00272519
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10