Clinical trial NCT04296656: Mothers' Parenting Satisfaction and Parenting Self-efficacy: An Evaluation of a Infant Calming Method
Official title: Mothers' Parenting Satisfaction and Parenting Self-efficacy During the Postpartum Period: An Evaluation of a Infant Calming Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting Satisfaction
Parenting Self-efficacy
Keywords: parenting satisfaction
parenting self-efficacy
behavioral infant calming intervention
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
First posted: 2020-03-05
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mothers in the intervention group were taught the infant calming intervention (the 5 S's). The mothers in both control and intervention groups received standard care and support provided by the midwives on the postpartum wards. Baseline data were collected before randomization in the hospital. Follow-up data were collected six to eight weeks postpartum at home.

The research groups were randomized in the following way: The mothers who were on one of the postpartum wards during the days when the intervention (5 S's) were taught, were randomly allocated to the group during the data collection period. The intervention was executed every second week, three days a week on Mondays, Wednesdays and Fridays. The intervention was executed until 120 mothers had participated in them. Control group mothers (n = 130) were recruited by in a similar fashion as the intervention group, but on alternate weeks.
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parenting satisfaction (PS)
timeFrame: Baseline
measure: Change in Parenting satisfaction (PS)
timeFrame: 6-8 weeks postpartum
measure: Parenting Self-Efficacy (PSE)
timeFrame: Baseline
measure: Change in Parenting Self-Efficacy (PSE)
timeFrame: 6-8 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
Study officials:
References: