- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01888809
Building Healthy Children (BHC)
Building Health Children: Randomized Controlled Trial (RCT) Evaluation
연구 개요
상세 설명
Building Healthy Children is a collaboration of social service and health care agencies, each providing evidence-based services to intervention families in a seamless package. Low-income parents who gave birth to their first child when they were under 21 and who were not involved in the child welfare system were targeted as an at-risk group for whom home visitation services would offer optimal preventive and cost-efficiency outcomes. Services include Interpersonal Psychotherapy [IPT] for maternal depression and Child Parent Psychotherapy [CPP] for maternal-child relationship development and trauma treatment, and Parents As Teachers [PAT]. Families are provided a tiered complement of BHC services based upon risk and current need.
Case management and outreach services are key to assure family engagement and full program participation. An assigned community outreach worker provides a consistent, nurturing relationship that helps retain families in the program and readies parents for the evidence-based treatments, movement towards goals, and behavior change. Outreach workers help to stabilize families and ensure compliance with medical appointments and recommended care.
Most importantly, BHC home-based services are integrated with primary care practices: pediatric, family medicine, and federally qualified neighborhood health center. These comprehensive services are compared with a screening and referral only group in a randomized design. Integration with the child's medical home is an all-inclusive approach to improve child health and well-being and to achieve desired program outcomes.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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Rochester, New York, 미국, 14608
- Mt. Hope Family Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participants will include patients drawn from Strong Pediatrics, Anthony Jordan Health Center, Rochester General Hospital, or Highland Family Medicine
- residents of Monroe County,
- Temporary Assistance for Needy Families (TANF) eligible,
- are neither currently active nor have had an indicated CPS report,
- have a mother who is or was under 21 at the birth of her first child, and
- has a maximum of two children under the age of three.
Exclusion Criteria:
- Children who have indicated Child Protective reports or who are in foster care at the time of recruitment
- Any children or mothers who are not able to complete the research protocol also will be excluded.
- Potential subjects suffering from extreme medical or psychiatric conditions (such as severe brain injury or psychosis) or serious cognitive impairments (such as mental retardation) that would render them incapable of completing research measures validly will be excluded.
- Mothers with thought disorder, severe depression or suicidality requiring hospitalization, severely limited intellectual functioning (IQ less than 70), and current maternal incarceration.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Comprehensive preventive services
Combined comprehensive services:Parents as Teachers Home visitation, Child-Parent Psychotherapy, and/or Interpersonal Psychotherapy with outreach support
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Combined evidence-based services:Parents as Teachers Home visitation, Child-Parent Psychotherapy, and/or Interpersonal Psychotherapy with outreach support
다른 이름들:
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활성 비교기: Screening and referral
Annual screening and referral for services as needed
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Prevention of indicated Child Protective Services (CPS) reports, including change over time
기간: Baseline and child's age of 12, 24, 36, 48, and 60 months
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Prevention of indicated Child Protective Services (CPS) reports on mothers and their children
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Baseline and child's age of 12, 24, 36, 48, and 60 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Reduction in family risks over time
기간: Baseline and child's age of 12, 24, 36, 48, and 60 months
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Changes in family risks, including maternal depression, domestic violence exposure, health outcomes, and family stability
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Baseline and child's age of 12, 24, 36, 48, and 60 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sheree L Toth, Ph.D., University of Rochester
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
기타 연구 ID 번호
- BHC-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
Comprehensive preventive services에 대한 임상 시험
-
Pusan National University Hospital모병
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Peking University모집하지 않고 적극적으로
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Potomac Health FoundationsNational Institutes of Health (NIH); National Institute of Drug Abuse모집하지 않고 적극적으로
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Zealand University HospitalHvidovre University Hospital모집하지 않고 적극적으로
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Washington University School of Medicine빼는
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Montefiore Medical CenterSan Diego Sexual Medicine; Beyond Meat모병
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Major Extremity Trauma Research Consortium완전한