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Life Skills Intervention for Adolescents Perinatally Infected With HIV

This study has been completed.
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):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00272519
First received: January 3, 2006
Last updated: December 14, 2012
Last verified: October 2012
History of Changes

January 3, 2006
December 14, 2012
June 2006
October 2006   (final data collection date for primary outcome measure)
Implement and evaluate the feasibility and acceptability of a modified life skills intervention [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
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.
Complete list of historical versions of study NCT00272519 on ClinicalTrials.gov Archive Site
Evaluate the feasibility and acceptability of an assessment battery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
  • 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.
Not Provided
Not Provided
 
Life Skills Intervention for Adolescents Perinatally Infected With HIV
Life Skills Intervention for Young Adolescents Perinatally Infected With HIV and Their Caregivers

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.

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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
HIV Infections
Behavioral: Life Skills Intervention
Developed to promote life skills among young adolescents perinatally infected with HIV
Other Name: No other names.
Experimental: Adolescent/caregiver dyads
Eight to ten adolescent/caregiver dyads
Intervention: Behavioral: Life Skills Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
October 2006
October 2006   (final data collection date for primary outcome measure)

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.
Both
11 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00272519
ATN 045b
No
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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)
Study Chair: Ahna Pai, Ph.D Children's Hospital of Philadelphia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP