Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns

NCT07834008 | Active Not Recruiting DMC

• 1 other identifier: N202606058
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate whether a structured nursing guidance program that increases fathers' participation in the care of hospitalized high-risk newborns improves maternal outcomes compared with routine nursing care. Parents of high-risk newborns admitted to a neonatal intermediate care unit will be enrolled. Families in the control group will receive routine nursing education provided during hospitalization. Families in the intervention group will receive a structured nursing guidance program that includes step-by-step parent education, written educational materials, instructional videos, and active father participation in breastfeeding support and infant care. The study will compare the two groups on maternal breastfeeding self-efficacy, perceived spousal support, perceived nursing support, parental stress, breastfeeding-related anxiety, and breastfeeding practices at hospital discharge and one month after discharge. The findings may help develop family-centered nursing interventions that enhance paternal involvement and improve breastfeeding outcomes for families with high-risk newborns.

Conditions

Prematurity; Low Birth Weight; Respiratory Distress Syndrome, Newborn; Neonatal Hyperbilirubinemia; Diarrhea

Keywords

High-risk newborns; Fathers; Father involvement; nursing education provided; breastfeeding; Parental participation

Outcome Measures

Primary Outcomes (1)

• Maternal Breastfeeding Self-Efficacy Score measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)

  Maternal breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), a 14-item self-report questionnaire. Each item is rated on a 5-point Likert scale from 1 (not at all confident) to 5 (always confident). Total scores range from 14 to 70, with higher scores indicating greater maternal breastfeeding self-efficacy.

  At the baseline, pre-intervention, and 1 month after hospital discharge.

Secondary Outcomes (1)

• Maternal Perceived Spousal Support Score measured by the Spousal Parenting Support Scale

  At the baseline, pre-intervention, and 1 month after hospital discharge.

Other Outcomes (2)

• Maternal Perceived Nursing Staff Support Score measured by the Nursing Staff Support Scale

  At thebaseline, pre-intervention.

• Maternal Perceived Stress Score measured by the Perceived Stress Scale

  At thebaseline, pre-intervention, and 1 month after hospital discharge.

Study Arms (1)

Step-by-step Parent Education and Active Father Participation

EXPERIMENTAL

Families assigned to the intervention group will receive a structured nursing guidance program designed to improve parents' knowledge, skills, and confidence in breastfeeding and infant care. The program will include step-by-step parent education, written educational materials, instructional videos, and active father participation in breastfeeding support and infant care. Fathers will be encouraged to provide practical, emotional, and informational support to mothers throughout the breastfeeding process.

Behavioral: step-by-step parent education; Behavioral: active father participation in breastfeeding support

Interventions

step-by-step parent education BEHAVIORAL

Parents will receive structured, step-by-step education on breastfeeding and infant care. The education will be provided through nursing guidance, written educational materials, and instructional videos to facilitate parents' understanding and application of recommended breastfeeding and infant-care practices.

Step-by-step Parent Education and Active Father Participation

active father participation in breastfeeding support BEHAVIORAL

Fathers will be actively involved in the breastfeeding process and infant care. They will be encouraged to provide practical, emotional, and informational support to mothers, thereby helping mothers establish and maintain breastfeeding and share responsibilities for infant care.

Step-by-step Parent Education and Active Father Participation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both parents must be 18 years of age or older.
• Both parents must live in the same residence.
• Both parents must be able to communicate in Mandarin Chinese or Taiwanese.
• Their child must be a high-risk newborn admitted to the neonatal intermediate care ward for at least three days.
• Their child must not have returned home after admission to the neonatal intermediate care ward.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

New Taipei City, 235, Taiwan

Location

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome, Newborn; Hyperbilirubinemia, Neonatal; Diarrhea; Breast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: September 22, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-08

Locations

TW (1)