Life Skills Intervention for Adolescents Perinatally Infected With HIV
This study has been completed.
Sponsor:
Westat
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Westat
ClinicalTrials.gov Identifier:
NCT00272519
First received: January 3, 2006
Last updated: February 29, 2016
Last verified: February 2016
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Purpose
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 | Intervention |
|---|---|
|
HIV Infections |
Behavioral: Life Skills Intervention |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Life Skills Intervention for Young Adolescents Perinatally Infected With HIV and Their Caregivers |
Resource links provided by NLM:
Further study details as provided by Westat:
Primary Outcome Measures:
- Implement and evaluate the feasibility and acceptability of a modified life skills intervention [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
| Enrollment: | 16 |
| Study Start Date: | June 2006 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: No other names.
|
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.
Eligibility| Ages Eligible for Study: | 11 Years to 14 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272519
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272519
Locations
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
Westat
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
| Study Chair: | Ahna Pai, Ph.D | Children's Hospital of Philadelphia |
More Information
Additional Information:
| Responsible Party: | Westat |
| ClinicalTrials.gov Identifier: | NCT00272519 History of Changes |
| Other Study ID Numbers: | ATN 045b |
| Study First Received: | January 3, 2006 |
| Last Updated: | February 29, 2016 |
| Health Authority: | United States: Federal Government |
Keywords provided by Westat:
|
HIV AIDS Adolescent HIV Positive |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on September 28, 2016