Life Skills Intervention for Adolescents Perinatally Infected With HIV

Not Applicable

Completed

• Conditions: HIV Infections
• Interventions: Behavioral: Life Skills Intervention

• Registration Number: NCT00272519
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

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 Timeline

• Study First Submitted: 2006-01-03
• Study First Submitted QC: 2006-01-03
• Study First Posted: 2006-01-06
• Study Start: 2006-06
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2016-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adolescent/caregiver dyads	Life Skills Intervention	Eight to ten adolescent/caregiver dyads

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States