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

NCT04121390 | Completed

• 1 other identifier: GCO 18-0778
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parenting Intervention

Keywords

Newborn care; Maternal anxiety; Maternal self-efficacy; Newborn care knowledge; Developmental trajectory; Positive parenting

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

Newborn Parenting Class

New Mother who attended the Newborn Parenting Class

Behavioral: Newborn Parenting Class

New Mothers

New Mothers who expressed interest, but did not attend the Newborn Parenting Class

Interventions

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.

Newborn Parenting Class

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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").

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Study Officials

• Dani Dumitriu, MD, PhD

  Columbia University Irving Medical Center; Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Blair S Hammond, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics and Psychiatry

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 9, 2019
• Study Start: May 28, 2018
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)