- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Boston Medical Center
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Boston, Massachusetts, Forenede Stater, 02118
- Tufts Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: 2
Sædvanlig pleje
|
|
Eksperimentel: 1
Problem Solving Education, a psycho-educational intervention
|
psycho-educational intervention
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Maternal Depressive Symptoms
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Health Care Supervision Schedule for Children
Tidsramme: 6 months
|
6 months
|
Immunization Schedule for Children
Tidsramme: 6 months
|
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
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 (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Hood-R03HD058075
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Kliniske forsøg med Maternel depression
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National Human Genome Research Institute (NHGRI)National Cancer Institute (NCI)Rekruttering
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Forman Christian College, PakistanUNICEFRekrutteringModerens sundhed | Maternal Health LiteracyPakistan
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University Hospital, Basel, SwitzerlandAfsluttetMaternal hæmodynamisk stabilitetSchweiz
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Federal University of PelotasAfsluttetPræmaturitet | Svangerskabsforhøjet blodtryk | Maternal post-partum depression | Maternal post-partum vægtretention | Barnets udviklingBrasilien
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University of CopenhagenUniversity of AarhusAktiv, ikke rekrutterendeSpædbarns sociale tilbagetrækning | Maternal postnatal depressionDanmark
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University of Milano BicoccaAfsluttetEkstern Cephalic version | Maternal Oral HydrationItalien
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Harvard School of Public Health (HSPH)Brigham and Women's HospitalAfsluttetGraviditetskomplikationer | Komplikationer ved kejsersnit | Maternal komplikation af graviditet | Kommunikation, TværfaglighedForenede Stater
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Aga Khan UniversityThe Hospital for Sick Children; Bill and Melinda Gates FoundationAktiv, ikke rekrutterendeNyfødt sygelighed | Maternal komplikation af graviditet | Perinatale problemerPakistan
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University of Alabama at BirminghamEunice Kennedy Shriver National Institute of Child Health and Human Development...RekrutteringMaternal Cytomegalovirus Infektioner | Cytomegalovirus medfødtForenede Stater
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Dong-Xin WangBeijing Obstetrics and Gynecology Hospital; Ningxia Women and Children's... og andre samarbejdspartnereRekrutteringFødselsdepression | Fødselssmerter | Afkom, voksen | Maternal anæstesi og analgesi, der påvirker foster eller nyfødte | NeuroudviklingsforsinkelseKina
Kliniske forsøg med Problem Solving Education
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University of Texas at AustinNational Institute of Mental Health (NIMH)AfsluttetDepressionForenede Stater
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Koç UniversityRekrutteringDepressive symptomer | Psykisk nød | Nedsat social funktionsevneKalkun
-
Koç UniversityRekruttering
-
University of ZurichAfsluttetDepression | PTSD | Angst | Trauma | Nød | Funktionsnedsættelser | Almindelige psykiske problemerSchweiz
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University of ZurichAfsluttetDepression | PTSD | Angst | Trauma | Nød | Funktionsnedsættelser | Almindelige psykiske problemerSchweiz
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The New SchoolColumbia University; Universidad del Norte; HIASRekrutteringMental sundhed velvære 1Colombia
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George Washington UniversityTranscultural Psychosocial Organization NepalAfsluttet
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George Washington UniversityYale University; Duke University; University of Witwatersrand, South Africa; Transcultural Psychosocial Organization NepalIkke rekrutterer endnuSensing-teknologier til behandling af maternal depression i lav-ressourceindstillinger (StandStrong)Postpartum depressionNepal
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VU University of AmsterdamNetherlands Institute for the Study of Crime and Law Enforcement (NSCR)Ikke rekrutterer endnuDepressiv lidelse | Angstlidelser | Psykisk nødHolland
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Istanbul Sehir UniversityEuropean CommissionAfsluttetDepression | Angst | Psykisk nød | Post traumatisk stress syndromKalkun