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Completed

NCT Number: NCT04121390

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mount Sinai Hospital

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Newborn Parenting Class

Behavioral

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.

Primary outcomes

  1. State-Trait Anxiety Inventory for Adults (STAI)

    Time frame: 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

  2. Karitane Parenting Confidence Scale (KPCS)

    Time frame: 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.

  3. Newborn Care Knowledge Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2019
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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