Life Skills Intervention for Adolescents Perinatally Infected With HIV

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272519
• Other study ID #: ATN 045b
• Status: Completed
• Phase: N/A
• First received: January 3, 2006
• Last updated: February 27, 2017
• Start date: June 2006
• Est. completion date: October 2006

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Life Skills Intervention
Developed to promote life skills among young adolescents perinatally infected with HIV

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implement and evaluate the feasibility and acceptability of a modified life skills intervention	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.	1 year
Secondary	Evaluate the feasibility and acceptability of an assessment battery	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.	1 year

External Links

•   Website for the Adolescent Trials Network for HIV/AIDS Interventions