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

NCT04296656 | Completed

• 1 other identifier: R18188H
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenting Satisfaction; Parenting Self-efficacy

Keywords

parenting satisfaction; parenting self-efficacy; behavioral infant calming intervention

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

Standard care on postpartum ward (breastfeeding and infant care guidance and support in recovering from childbirth and transitioning into parenthood).

Interventions

The 5 S's infant calming intervention BEHAVIORAL

5 simple steps to calm a fussy or crying infant. Steps include swaddling, side position, sound (white noise), swing and suck.

Intervention group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, Pirkanmaa, 33520, Finland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 5, 2020
• Study Start: December 3, 2018
• Primary Completion: May 20, 2019
• Study Completion: May 31, 2019
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2022-2027
• Access Criteria: Permission from Tampere University Hospital

Locations

FI (1)