- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01214967
Problem Solving Education and Neonatal Intensive Care Unit (NICU) Mothers (Project Solve)
Empowering Low Income Mothers With Preterm Infants: a Randomized Controlled Trial
Premature infants are born at substantial risk for poor health and developmental outcomes, which commonly include hearing and vision problems, developmental delays, and poor school performance. Premature infants of low-income families face additional social risks known to worsen these outcomes. The Institute of Medicine recognized this important public health problem in its 2006 report, Preterm Birth, which argued for the need to improve the quality of follow-up care for preterm infants discharged from the neonatal intensive care unit (NICU). The underpinning of this proposal is that maternal depression - common among families of premature infants - interferes with adherence to follow-up services, and (both through this mechanism and directly) adversely impacts child health and development. Conversely, alleviating depressive symptoms among these women represents a promising strategy to improve adherence to NICU follow-up services and to improve the outcomes of this vulnerable population.
This project aims to mitigate the adverse effects of maternal depression in this specific high-risk population by testing a theory-based, parent-directed empowerment strategy, called Problem Solving Education (PSE). In the past, similar strategies have been proven effective for improving the mood and functioning of depressed adults, and for improving adherence to medical treatment. However, they have never been tested in the setting of a parent-child relationship or among families of premature infants.
This project involves a clinical trial of PSE among 50 low-income mothers at risk for depression, who have premature infants in two Boston NICUs: Boston Medical Center and Tufts Medical Center. The investigators aim to determine the impact of PSE on maternal depressive symptoms and functioning, and adherence to child health supervision and immunization schedules, vision screening, and early intervention evaluation for babies with suspected developmental delays.
Approximately 100,000 children are born prematurely to low-income families each year. Parent-directed PSE aims to improve outcomes for these children through the prevention and/or attenuation of maternal depressive symptoms, as well as through family activation and promotion of adherence to follow-up care. If successful, PSE could also provide the cornerstone of a more generalizable empowerment strategy for families of children with chronic medical conditions.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02118
- Boston Medical Center
-
Boston, Massachusetts, 미국, 02118
- Tufts Medical Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Baby is ≤ 33 weeks gestational age and is expected to survive.
- Baby qualifies to receive WIC
- Mother is comfortable in English or Spanish.
Exclusion Criteria:
- Mother has psychosis
- Mother endorses suicidal ideation
- Custody of baby is uncertain
- Mother is cognitively limited, per judgment of NICU attending physician
- Baby is critically ill, per judgment of NICU attending physician
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: 2
평소 케어
|
|
|
실험적: 1
Problem Solving Education, a psycho-educational intervention
|
psycho-educational intervention
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Maternal Depressive Symptoms
기간: 6 months
|
6 months
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Health Care Supervision Schedule for Children
기간: 6 months
|
6 months
|
|
Immunization Schedule for Children
기간: 6 months
|
6 months
|
공동 작업자 및 조사자
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
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. .
산모 우울증에 대한 임상 시험
-
University of Haifa완전한산후 기간 | 산모 정신 건강 | Parenting / Maternal Behavior | 초산 (첫 아이를 임신한 산모) | 산후 우울 증상이스라엘
Problem Solving Education에 대한 임상 시험
-
Chia-Tzu Line완전한
-
Emine ErginSaglik Bilimleri Universitesi아직 모집하지 않음
-
Academisch Medisch Centrum - Universiteit van Amsterdam...모집하지 않고 적극적으로월경통 | 생리주기 | 생리통 | 모바일 건강 | 심한 월경 출혈 | 생리통 | 생리통(월경통) | 일상 생활 | 월경 건강 개입 | 모바일 건강 기술(mHealth)네덜란드
-
Second Affiliated Hospital, School of Medicine,...완전한
-
University of SheffieldUniversity of Liverpool; University of Manchester; University of Melbourne모집하지 않고 적극적으로
-
University of OxfordBeijing Normal University; Beijing Stars and Rain Education Institute for Autism완전한아동 학대 | 부모-자녀 관계 | 자폐 스펙트럼 장애 | 육아 | 아동 행동 문제 | 가족 관계 | 정신 건강 문제중국