- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- Case Western Reserve University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Ahna L Hoff, Ph.D., Case Western Reserve University School of Medicine and Rainbow Babies and Childrens Hospital
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ATN 045a
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