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Life Skills Intervention for Adolescents Perinatally Infected With HIV

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Life Skills Intervention
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Infections focused on measuring HIV, AIDS, Adolescent, HIV Positive

Eligibility Criteria

11 Years - 14 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adolescent/caregiver dyads

Arm Description

Eight to ten adolescent/caregiver dyads

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 3, 2006
Last Updated
February 27, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00272519
Brief Title
Life Skills Intervention for Adolescents Perinatally Infected With HIV
Official Title
Life Skills Intervention for Young Adolescents Perinatally Infected With HIV and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, AIDS, Adolescent, HIV Positive

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adolescent/caregiver dyads
Arm Type
Experimental
Arm Description
Eight to ten adolescent/caregiver dyads
Intervention Type
Behavioral
Intervention Name(s)
Life Skills Intervention
Other Intervention Name(s)
No other names.
Intervention Description
Developed to promote life skills among young adolescents perinatally infected with HIV
Primary Outcome Measure Information:
Title
Implement and evaluate the feasibility and acceptability of a modified life skills intervention
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Evaluate the feasibility and acceptability of an assessment battery
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahna Pai, Ph.D
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Life Skills Intervention for Adolescents Perinatally Infected With HIV

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