SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers

Study Overview
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Brief Summary
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In the last decade, infants are born into a social environment in which the smartphone has become an essential part of our lives. Smartphone use draws the mother's attention during mother-infant interactions and thus may affect the infant development as well as maternal self-efficacy. However, the effects of smartphone use reduction among breastfeeding mothers during their interactions with their infants have not been studied yet. In the present study, we propose to evaluate a SMaRT Mom intervention that we have developed, to manage and reduce smartphone use during breastfeeding. The purpose of the study is to evaluate the effects of the SMaRT Mom intervention on breastfeeding mothers' biobehavioral mechanisms, self-efficacy and the socioemotional characteristics of their infants. This will extend our knowledge of the peculiarities of early mother-infant interactions in the digital era, when smartphones play a critical role.

Official Title
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SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers - An Intervention Study

Conditions
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Smartphone Addiction, Breastfeeding, Infant Behavior, Mother-Infant Interaction

Intervention / Treatment
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* Behavioral: SMaRT Mom


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3-6 months old infant Smartphone Addiction Scale' cut-off (31 and above) Exclusion Criteria: No neurological disorders No heart disease No anxiety and depression No use of psychiatric drugs

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The SMaRT Mom intervention plan will be administered for one week during which mothers will be instructed not using their smartphone while breastfeeding. Before and after the intervention week, two lab sessions will be take place in which mothers in both intervention and control groups will be asked to take a screen shot of their smart digital use of the past week, and will be connected to the electrophysiological monitoring systems to assess their biobehavioral responses during: baseline, the smartphone cue-reactivity task, breastfeeding and face-to-face interaction while using or not using the smartphone. Following the first lab visit, mothers will be instructed to follow the intervention program. The participants will be asked to complete three daily reports of any distractions while breastfeeding. During the intervention week, two remote sessions (20 minutes each) will be performed by a research assistance to support the implementation of the intervention plan.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will be instructed not to use the smartphone during breastfeeding for a week | Behavioral: SMaRT Mom<br>* SMaRT Mom intervention that we have developed is based on several approaches to digital addiction detection, prevention, and intervention aimed to help breastfeeding mothers to manage and reduce smartphone use during breastfeeding. The SMaRT Mom intervention results will be measured in changes in two main outcomes: 1) reduced maternal reports of their infants' negative emotionality, and 2) increased maternal self-efficacy as distal outcomes as well as two proximal outcomes: 1) breastfeeding as a rewarding experience, and 2) maternal attention towards their infant during breastfeeding. We will then assess changes in breastfeeding mothers' neural activity, physiology and behavior before and after the implementation of the SMaRT Mom intervention, as potential mechanisms underlying changes in the main outcomes of the intervention.<br>|
| No Intervention: Control<br>Participants will not be instructed not to use the smartphone during breastfeeding for a week | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant temperament | Infants' temperament will be reported by breastfeeding mothers before and after the intervention week using the Infant Behavior Questionnaire - Revised - Very Short Form (IBQ-rvsf). Scale scores represent the mean score of all scale items applicable to the child, as judged by the caregiver. 1. Sum all numerical item responses for a given scale. Note that: a) If caregiver omitted an item, that item receives no numerical score; b) If caregiver checked the does not apply response option for an item, that item receives no numerical score; 2. Divide the total by the number of items receiving a numerical response. Not including items marked does not apply (N/A) or items receiving no response in determining the number of items. The surgency, negative affect and effortful control subscales' items will be averaged | Pre (day 1) and post (day 8) lab visit (before and after intervention/control week) | 
| Maternal self-efficacy | Maternal self-efficacy questionnaire (MSQ) will be self-reported by breastfeeding mothers before and after the intervention week. The scale applies a special method to measure maternal self-efficacy and mostly focuses on a mother's infant care responsibilities. The scale consists of 10 items.Higher score indicates higher maternal self-efficacy | Pre (day 1) and post (day 8) lab visit (before and after intervention/control week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding as a rewarding experience | The rewarding experience of breastfeeding will be self-reported by mothers before and after the intervention week (How rewarding is the experience of breastfeeding for you?) | Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week | 
| Self-reported maternal attention towards infant | Maternal attention towards the infant will be self-reported by mothers before and after the intervention week (How attentive do you feel towards your infant during breastfeeding?) | Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week | 
| Video recorded maternal attention towards infant | Maternal attention towards the infant will be video recorded during both laboratory sessions | day 1 and day 8 during lab visits | 
| Changes in breastfeeding mothers' neural activity - Frontal asymmetry | Frontal asymmetry during maternal baseline, breastfeeding and mother-infant face-to-face interaction EEG data will be acquired from breastfeeding mothers' heads using Enobio8 device with eight electrodes from the frontal, and central-parietal areas - Fp1, Fp2, F3, F4, F7, F8, P3 and P4 and voltage fluctuations in the alpha frequency band will be measured between pairs of electrodes that will be produced by the excitation of neuronal synapses. | day 1 and day 8 during lab visits | 
| Changes in breastfeeding mothers' neural activity - ERP | Event related response during the smartphone cue-reactivity task, attentional bias is indicated by an enhancement in the late positive potential (LPP), which is strongly evoked by emotionally salient stimuli. The LPP is maximum over central-parietal regions occurring between 300 and 700 ms following an emotional stimulus | day 1 and day 8 during lab visits | 
| Changes in breastfeeding mothers' physiological responses - HRV | Heart Rate Variability (HRV) will be measured via The MindWare Mobile Recorder (MindWare Technologies, Inc., Gahanna, OH), a well-validated and specialized hardware and software system that is aimed at monitoring autonomic balance, cardiac performance, respiratory measurements and activity. Participants are each will be fitted with a MindWare Mobile device and specialized electrodes to measure the electrocardiogram (allows to derive HRV), Z0, dz/dt (allows to assess respiration and cardiology impedance) and SCL (allows to derive electrodermal activity from the skin) (for similar method see Nomkin & Gordon, 2021). | day 1 and day 8 during lab visits | 
| Changes in breastfeeding mothers' physiological responses - Electrodermal activity | Skin Conductance Level (SCL) will be measured via The MindWare Mobile Recorder (MindWare Technologies, Inc., Gahanna, OH), a well-validated and specialized hardware and software system that is aimed at monitoring autonomic balance, cardiac performance, respiratory measurements and activity. Participants are each will be fitted with a MindWare Mobile device and specialized electrodes to measure the electrocardiogram (allows to derive HRV), Z0, dz/dt (allows to assess respiration and cardiology impedance) and SCL (allows to derive electrodermal activity from the skin) (for similar method see Nomkin & Gordon, 2021). | day 1 and day 8 during lab visits | 
| Changes in breastfeeding mothers' physiological responses - Cardiograph Impedance | Cardiograph Impedance will be measured via The MindWare Mobile Recorder (MindWare Technologies, Inc., Gahanna, OH), a well-validated and specialized hardware and software system that is aimed at monitoring autonomic balance, cardiac performance, respiratory measurements and activity. Participants are each will be fitted with a MindWare Mobile device and specialized electrodes to measure the electrocardiogram (allows to derive HRV), Z0, dz/dt (allows to assess respiration and cardiology impedance) and SCL (allows to derive electrodermal activity from the skin) (for similar method see Nomkin & Gordon, 2021). | day 1 and day 8 during lab visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smartphone addiction, Problematic smartphone use, Breastfeeding, Infant temperament, Mother-infant interaction