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Assessing the Impact of Mount Sinai Parenting Center's Newborn Class

8. oktober 2019 opdateret af: Dani Dumitriu, Icahn School of Medicine at Mount Sinai

Accessing the Effectiveness of a Pediatrician-led Newborn Parenting Class on Maternal Newborn Care Knowledge, Anxiety and Confidence

This study is the first to evaluate the effectiveness of a Newborn Parenting Class designed by Mount Sinai Parenting Center. The study measures how effective the class is in improving maternal knowledge on newborn care, decreasing maternal self-perceived anxiety and increasing maternal confidence.

Studieoversigt

Status

Afsluttet

Betingelser

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

Observationel

Tilmelding (Faktiske)

82

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New York
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants of the study are mothers who delivered vaginally a singleton with no major perinatal complications at Mount Sinai Hospital. Participants were not randomized into control and intervention. This was an Observational study of eligible mothers than attended the Newborn Class ("intervention group") and eligible mothers who wanted to but were not able to attend the Newborn Class because it was not available during their stay at the hospital ("control group").

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. maj 2018

Primær færdiggørelse (Faktiske)

2. august 2019

Studieafslutning (Faktiske)

2. august 2019

Datoer for studieregistrering

Først indsendt

7. oktober 2019

Først indsendt, der opfyldte QC-kriterier

8. oktober 2019

Først opslået (Faktiske)

9. oktober 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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

Kliniske forsøg med Newborn Parenting Class

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