- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00224900
Development of a Life Skills Intervention for Young Adolescents Perinatally-Infected With HIV and Their Caregivers
Development of a Life Skills Intervention for Young Adolescents Perinatally-Infected With HIV and Their Caregivers Part A: Focus Group And Measurement Evaluation
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This study is designed to collect information from HIV-1 perinatally infected adolescents for the development of a pilot study that will use a life skills intervention model. One focus group comprised of adolescents and one focus group comprised of their caregivers will use a series of open-ended questions to facilitate a group discussion to define the life skills intervention model. Ten young adolescents, ages 11 to 14 years, and their caregivers will participate in these focus groups at Rainbow Babies and Children's Hospital in Cleveland, Ohio. The protocol will be site-restricted for participation. The responses from the focus group will be used to tailor the proposed life skills intervention model and to provide a detailed description of intervention content including: common peer issues of young adolescents perinatally infected with HIV, typical sexual knowledge and behaviors, typical areas of conflict between adolescents and caregivers, and common ways of managing conflict. In addition, those that participate in the focus group will be asked to complete a series of questionnaires in order to assess the appropriateness of the proposed measurement battery for adolescents perinatally infected with HIV and their caregivers.
Findings from this study (ATN 045- Part A) will be used in the development of a proposal for a pilot study of the life skills intervention model (ATN 045-Part B). The pilot study will examine the feasibility of successfully providing a life skills intervention to HIV-1 infected young adolescents at an ATN clinical site, the acceptability of such an intervention in young adolescents, as well as the logistics of providing such an intervention.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Case Western Reserve University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Clinically-identified HIV-1 infected subjects 11-14 years of age and their caregivers.
- HIV status has been disclosed to the adolescent.
- HIV-1 infection transmission due to perinatal infection as identified by treating physician.
- Caregiver is legal guardian of the adolescent as indicated by the medical team in the clinic from which recruitment will be conducted.
- Adolescent lives with the caregiver.
- Adolescent and caregiver speak English.
Exclusion Criteria:
- Caregiver permission denied or adolescent does not assent.
- Adolescent previously diagnosed as mentally retarded as reported by caregiver through school and/or other psychological testing.
- Adolescent and/or caregiver too medically fragile. Medically fragile is functionally defined as being physically unable to attend the group.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Ahna L Hoff, Ph.D., Case Western Reserve University School of Medicine and Rainbow Babies and Childrens Hospital
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ATN 045a
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