- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ohio
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Cleveland, Ohio, 미국, 44106
- Case Western Reserve University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Ahna L Hoff, Ph.D., Case Western Reserve University School of Medicine and Rainbow Babies and Childrens Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ATN 045a
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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