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Completed

NCT Number: NCT00272519

Life Skills Intervention for Adolescents Perinatally Infected With HIV

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.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Life Skills Intervention

Behavioral

Developed to promote life skills among young adolescents perinatally infected with HIV

Other names: No other names.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Life Skills Intervention for Young Adolescents Perinatally Infected With HIV and Their Caregivers

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jan 6, 2006
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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