Life Skills Intervention for Adolescents Perinatally Infected With HIV

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT00272519

Collaborator

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

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Behavioral: Life Skills Intervention	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adolescent/caregiver dyads Eight to ten adolescent/caregiver dyads	Behavioral: Life Skills Intervention Developed to promote life skills among young adolescents perinatally infected with HIV Other Names: No other names.

Arm

Intervention/Treatment

Experimental: Adolescent/caregiver dyads

Eight to ten adolescent/caregiver dyads

Behavioral: Life Skills Intervention

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

Other Names:

No other names.

Outcome Measures

Primary Outcome Measures

Implement and evaluate the feasibility and acceptability of a modified life skills intervention [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 Outcome Measures

Evaluate the feasibility and acceptability of an assessment battery [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.