Life Skills Intervention for Adolescents Perinatally Infected With HIV

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH) National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00272519

Purpose

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
HIV Infections	Behavioral: life skills

MedlinePlus related topics: AIDS Caregivers

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Life Skills Intervention for Young Adolescents Perinatally Infected With HIV and Their Caregivers

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

Primary Outcome Measures:

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:

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.

Estimated Enrollment:	40
Study Start Date:	June 2006
Estimated Study Completion Date:	April 2007

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.

Eligibility

Ages Eligible for Study:	11 Years to 14 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272519

Locations

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

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

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

Study ID Numbers:	ATN 045b
Study First Received:	January 3, 2006
Last Updated:	April 2, 2007
ClinicalTrials.gov Identifier:	NCT00272519
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

HIV
AIDS
Adolescent
HIV Positive

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Seropositivity
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009