- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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New York
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New York, New York, Forente stater, 10029
- Mount Sinai Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Newborn Parenting Class
New Mother who attended the Newborn Parenting Class
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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.
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New Mothers
New Mothers who expressed interest, but did not attend the Newborn Parenting Class
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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Immediately after enrollment (Day 1)
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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.
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Immediately after enrollment (Day 1)
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Newborn Care Knowledge Questionnaire
Tidsramme: Immediately after enrollment (Day 1)
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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)
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Dani Dumitriu, MD, PhD, Columbia University Irving Medical Center; Icahn School of Medicine at Mount Sinai
- Hovedetterforsker: Blair S Hammond, MD, Icahn School of Medicine at Mount Sinai
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- GCO 18-0778
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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