Life Skills Intervention for Adolescents Perinatally Infected With HIV

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Life Skills Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adolescent/caregiver dyads<br>Eight to ten adolescent/caregiver dyads | Behavioral: Life Skills Intervention<br>* Developed to promote life skills among young adolescents perinatally infected with HIV<br>* Other names: No other names.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, Adolescent, HIV Positive