Mothers' Parenting Satisfaction and Parenting Self-efficacy: An Evaluation of a Infant Calming Method

Mothers' Parenting Satisfaction and Parenting Self-efficacy During the Postpartum Period: An Evaluation of a Infant Calming Method

The main aim of this study is to investigate how to support families with an excessively crying or fussy infant during the first months of the child. The purpose is to discover how an excessively crying or fussy infant affects the mothers' parenting satisfaction and parenting self-efficacy. Furthermore the purpose is to investigate how a behavioral intervention (The 5 S's) affects the infants' mothers' parenting satisfaction and self-efficacy and to evaluate the effectiveness of the intervention.

Study Overview

• Status: Completed
• Conditions: Parenting Satisfaction; Parenting Self-efficacy
• Intervention / Treatment: Behavioral: The 5 S's infant calming intervention

Detailed Description

This is a randomized controlled follow-up parallel trial that compares PSE and PS in an intervention and control group. The data was collected during March 1st to May 20th, 2019 from three postpartum wards. The mothers were recruited by midwives on the wards after childbirth. The baseline sample size was 250 mothers, which is based on a conducted power analysis. The sample size calculation was based on previous study, from which the standard deviation (0.81) for change in parental satisfaction was calculated. Baseline data were collected before randomization in the hospital. Follow-up data were collected six to eight weeks postpartum at home.

The instruments to assess the study outcomes were the parenting self-efficacy (PSE) scale developed and validated by Salonen et al. and parenting satisfaction (PS) scale, the evaluation subscale of the questionnaire "What Being the Parent of a New Baby is Like" by Pridham & Chang, 1989.

Data were analyzed with SPSS statistical software for Windows, release 25. Descriptive statistics included frequencies, percentages, means and medians. Total scores for the PSE instrument and WBPL-R evaluation subscale (PS) were calculated by summing the scores for all items and dividing the sum by the number of items. Higher scores indicated better outcomes. Comparisons between groups were made of mother characteristics, PSE and PS. Due to skewed distributions, non-parametric tests were used. Mann-Whitney U tests were used for two group comparisons, and Kruskal Wallis tests were used for three or more group comparisons.

Results have not yet been reported.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33520
      • Tampere University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Primiparous mothers
• Multiparous mothers
• Mothers of healthy infants rooming in (with mother)

Exclusion Criteria:

• Mothers with infants who were treated on another ward during data collection
• Mothers with multiple infants
• Mothers with inability to understand Finnish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; Mothers in the intervention group were taught the infant calming technique 5 S's, a part of The Happiest Baby (THB) method. THB is based on the theory that infants have an innate "calming reflex" that can soothe infant fussing, excessive crying and prolong sleep. This reflex is triggered by five activities that mimic the sensory milieu of the womb. The 5 S's include swaddling, side position, sound (white noise), swing and suck. The intervention consisted of a 20-minute face-to-face guidance session with the researcher, executed individually in the mother's hospital room. Each mother was given a leaflet to take home that explained the 5 steps in short. Safety issues, such as safest sleep position (supine), allowing hips to flex and how to avoid overheating when swaddled, were addressed. The same researcher executed each guidance session to maintain standardization.	Behavioral: The 5 S's infant calming intervention; 5 simple steps to calm a fussy or crying infant. Steps include swaddling, side position, sound (white noise), swing and suck.
No Intervention: Control group; Standard care on postpartum ward (breastfeeding and infant care guidance and support in recovering from childbirth and transitioning into parenthood).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting satisfaction (PS)	The questionnaire "What Being the Parent of a New Baby is Like" measures parenting satisfaction and has three distinct subscales: evaluation (11 items), centrality (8 items), and life change (6 items). The Evaluation subscale contains 11 items where the mothers responded on a nine-point scale with verbal end anchors, such as 1 = not at all (satisfied) to 9 = completely (satisfied). Higher scores indicate more PS. The evaluation subscale contains items such as "How well do you know your baby?", "How satisfied are you in being a parent of a new baby?" and "How satisfied are you with baby care tasks?".	Baseline
Change in Parenting satisfaction (PS)	The questionnaire "What Being the Parent of a New Baby is Like" measures parenting satisfaction and has three distinct subscales: evaluation (11 items), centrality (8 items), and life change (6 items). The Evaluation subscale contains 11 items where the mothers responded on a nine-point scale with verbal end anchors, such as 1 = not at all (satisfied) to 9 = completely (satisfied). Higher scores indicate more PS. The evaluation subscale contains items such as "How well do you know your baby?", "How satisfied are you in being a parent of a new baby?" and "How satisfied are you with baby care tasks?".	6-8 weeks postpartum
Parenting Self-Efficacy (PSE)	This questionnaire measures parenting self efficacy and is domain-specific, and it includes 27 items measuring different infant care skills. These skills are cognitive skills (11 items) such as "I know how to calm a crying baby", affective skills (seven items) such as "I know what my baby enjoys" and behavioural skills (nine items) such as "I'm able to put my baby to sleep". The instrument has a six-point Likert scale 1 = "strongly disagree" to 6 = "strongly agree". Total parenting self-efficacy scores were calculated by adding up the scores of all items and dividing the sum by the number of items. In addition, the score for each subcategory was calculated by adding up the scores of all items in the subcategory and dividing the sum by the number of items. In this instrument, higher scores indicate better outcomes.	Baseline
Change in Parenting Self-Efficacy (PSE)	This questionnaire measures parenting self efficacy and is domain-specific, and it includes 27 items measuring different infant care skills. These skills are cognitive skills (11 items) such as "I know how to calm a crying baby", affective skills (seven items) such as "I know what my baby enjoys" and behavioural skills (nine items) such as "I'm able to put my baby to sleep". The instrument has a six-point Likert scale 1 = "strongly disagree" to 6 = "strongly agree". Total parenting self-efficacy scores were calculated by adding up the scores of all items and dividing the sum by the number of items. In addition, the score for each subcategory was calculated by adding up the scores of all items in the subcategory and dividing the sum by the number of items. In this instrument, higher scores indicate better outcomes.	6-8 weeks postpartum

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Tampere University

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): May 20, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: parenting satisfaction; parenting self-efficacy; behavioral infant calming intervention
• Other Study ID Numbers: R18188H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication, also Study Protocol will be allowed in 2022, after discussions and in good cooperation with Tampere University Hospital.
• IPD Sharing Time Frame: 2022-2027
• IPD Sharing Access Criteria: Permission from Tampere University Hospital
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No