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

Parenting Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04121390
• Other study ID #: GCO 18-0778
• Status: Completed
• Start date: May 28, 2018
• Est. completion date: August 2, 2019

Study information

• Verified date: October 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parenting Intervention

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State-Trait Anxiety Inventory for Adults (STAI)	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)
Primary	Karitane Parenting Confidence Scale (KPCS)	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)
Primary	Newborn Care Knowledge Questionnaire	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)