- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04121390
Assessing the Impact of Mount Sinai Parenting Center's Newborn Class
Accessing the Effectiveness of a Pediatrician-led Newborn Parenting Class on Maternal Newborn Care Knowledge, Anxiety and Confidence
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The important role positive parenting plays in promoting a child's developmental trajectory has led to the design and implementation of many postpartum education initiatives. With 99% of babies in the U.S. born in hospitals, there is a uniqueness of being in the hospital for an extended period of time with the opportunity to educate parents on the importance of promoting early development. Pediatricians are uniquely well-positioned to address both medical and developmental concerns parents may have during critical periods in a child's development, yet very few interventions are led by pediatricians. The Mount Sinai Parenting Center designed the Newborn Parent Education and Discharge Class (hereafter referred to as Newborn Class) to address this issue. The class is 1-hour long and taught be pediatric attending and residents to all families who deliver well babies at Mount Sinai. The class aims to educate parents about medical issues, responsive parenting, and sleep. It is currently taught every Tuesdays and Thursdays. Because of the limited availability of the class, not all mothers have the opportunity to attend. This research study will survey first time mothers of newborns to explore the effectiveness of attending the class. The study team hypothesizes that attending the class would result in increased knowledge on newborn care, increased confidence levels and decreased levels of anxiety.
First time mothers who delivered a full-term singleton vaginally with no major complications were included in the study. Only mothers who attended the class (intervention) or expressed desire to attend class but were discharged before a class was offered (control) were included in analysis. Mothers were recruited between May 2018 and August 2019 at the Klingenstein Pavilion of Mount Sinai. Maternal self-perceived anxiety and confidence were measured using standardized scales, and knowledge on newborn care was assessed using an internally-developed scale.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10029
- Mount Sinai Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- First-time mother
- Above 18 years old
- Vaginal delivery of a healthy full-term singleton
- No major perinatal complications (per self-report)
- Consent to participate.
Exclusion Criteria:
-none
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Newborn Parenting Class
New Mother who attended the Newborn Parenting Class
|
Newborn Parenting Class designed by Mount Sinai Parenting Center.
The class is 1-hour long and taught be pediatric attending and residents to all families who deliver well babies at Mount Sinai.
|
New Mothers
New Mothers who expressed interest, but did not attend the Newborn Parenting Class
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
State-Trait Anxiety Inventory for Adults (STAI)
Tidsramme: Immediately after enrollment (Day 1)
|
Maternal self-perceived anxiety was measured using State-Trait Anxiety Inventory for Adults (State only).
A 40 self-report items questionnaire, each item scored on 4-point likert-type response scale from 1 (not at all) to 4 (almost always), full range from 20 to 80, with higher score STAI scores suggesting higher levels of anxiety
|
Immediately after enrollment (Day 1)
|
Karitane Parenting Confidence Scale (KPCS)
Tidsramme: Immediately after enrollment (Day 1)
|
Confidence level was measured using Karitane Parenting Confidence Scale.
A 15 item instrument with ach item on the KPCS is scored 0, 1, 2, or 3. Total score range from 0-45, with higher score indicating the parent feeling more confident.
|
Immediately after enrollment (Day 1)
|
Newborn Care Knowledge Questionnaire
Tidsramme: Immediately after enrollment (Day 1)
|
Knowledge on newborn care was assessed using an internally-developed scale, developed by a team of pediatricians and specialists. Total score ranges from 0-10, with higher score indicating higher level of knowledge. |
Immediately after enrollment (Day 1)
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Dani Dumitriu, MD, PhD, Columbia University Irving Medical Center; Icahn School of Medicine at Mount Sinai
- Ledende efterforsker: Blair S Hammond, MD, Icahn School of Medicine at Mount Sinai
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- GCO 18-0778
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Forældreintervention
-
Research Foundation for Mental Hygiene, Inc.AfsluttetKort videobaseret intervention | Vignettebaseret intervention | Ikke-intervention kontrolarmForenede Stater
-
Matrouh UniversityAfsluttet
-
University Hospital TuebingenUkendtIntervention | Cronic Limb IshemiaTyskland
-
Zhejiang UniversityAfsluttet
-
University of HaifaAfsluttetPsykologisk intervention | Internet-baseret intervention | InterventionsundersøgelseIsrael
-
The Christie NHS Foundation TrustTerumo UK Ltd.Ikke rekrutterer endnuRadiologi, Intervention
-
Matrouh UniversityAfsluttetOpførsel | InterventionEgypten
-
Assistance Publique - Hôpitaux de ParisAfsluttetIntervention | NeurokirurgiFrankrig
-
University of the West of EnglandUnilever R&D; Nike; Laureus; Tucker Center for Research on Girls & Women in...AfsluttetIntervention | VentelistekontrolDet Forenede Kongerige
-
Chin-Tsung ShenAfsluttet
Kliniske forsøg med Newborn Parenting Class
-
Center for Parents and Infants, IcelandThe Icelandic Nurses' Association; Health care of the capital area, Iceland og andre samarbejdspartnereAfsluttetInteraktion mellem mor og spædbarnIsland
-
University of AarhusAfsluttetForældre-barn relationerDanmark
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbejdspartnereTilmelding efter invitation
-
Eunice Kennedy Shriver National Institute of Child...Ukendt
-
University of ManitobaUniversity of Calgary; Tactica Interactive; Centre for Healthcare Innovation og andre samarbejdspartnereUkendt
-
Rehabilitation Centre for Children, CanadaAfsluttetAutismespektrumforstyrrelse (ASD) | UdviklingsforstyrrelseCanada
-
University of California, San FranciscoNational Institute of Mental Health (NIMH); University of California, BerkeleyAfsluttetAttention Deficit Disorder med hyperaktivitetForenede Stater
-
University of NottinghamNational Institute for Health Research, United Kingdom; Institute of Mental...UkendtAttention Deficit Hyperactivity Disorder (ADHD)
-
Brigham and Women's HospitalChild TrendsAfsluttetFødselsdepression | Spædbørns udvikling | For tidligt spædbarnForenede Stater