Life Skills Intervention for Adolescents Perinatally Infected With HIV

February 27, 2017 updated by: University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implement and evaluate the feasibility and acceptability of a modified life skills intervention
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the feasibility and acceptability of an assessment battery
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

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

Investigators

  • Study Chair: Ahna Pai, Ph.D, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

January 3, 2006

First Submitted That Met QC Criteria

January 3, 2006

First Posted (Estimate)

January 6, 2006

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATN 045b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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