SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers (SMaRT)
Primary Purpose
Smartphone Addiction, Breastfeeding, Infant Behavior
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SMaRT Mom
Sponsored by
About this trial
This is an interventional treatment trial for Smartphone Addiction focused on measuring Smartphone addiction, Problematic smartphone use, Breastfeeding, Infant temperament, Mother-infant interaction
Eligibility Criteria
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
Sites / Locations
- Gonda Brain Center, Bar-Ilan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Participants will be instructed not to use the smartphone during breastfeeding for a week
Participants will not be instructed not to use the smartphone during breastfeeding for a week
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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?")
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?")
Video recorded maternal attention towards infant
Maternal attention towards the infant will be video recorded during both laboratory sessions
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.
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
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).
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).
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).
Full Information
NCT ID
NCT06030830
First Posted
August 27, 2023
Last Updated
September 2, 2023
Sponsor
Bar-Ilan University, Israel
1. Study Identification
Unique Protocol Identification Number
NCT06030830
Brief Title
SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers
Acronym
SMaRT
Official Title
SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers - An Intervention Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bar-Ilan University, Israel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smartphone Addiction, Breastfeeding, Infant Behavior, Mother-Infant Interaction
Keywords
Smartphone addiction, Problematic smartphone use, Breastfeeding, Infant temperament, Mother-infant interaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
The intervention given to the intervention group will be hidden from participants in the control group, and they will not be asked to refrain from using their smartphones for a week. Participants in the control group will be given information about the intervention week after the second lab visit and allowed to undergo the same intervention the following week.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will be instructed not to use the smartphone during breastfeeding for a week
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will not be instructed not to use the smartphone during breastfeeding for a week
Intervention Type
Behavioral
Intervention Name(s)
SMaRT Mom
Intervention Description
"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.
Primary Outcome Measure Information:
Title
Infant temperament
Description
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
Time Frame
Pre (day 1) and post (day 8) lab visit (before and after intervention/control week)
Title
Maternal self-efficacy
Description
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
Time Frame
Pre (day 1) and post (day 8) lab visit (before and after intervention/control week)
Secondary Outcome Measure Information:
Title
Breastfeeding as a rewarding experience
Description
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?")
Time Frame
Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week
Title
Self-reported maternal attention towards infant
Description
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?")
Time Frame
Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week
Title
Video recorded maternal attention towards infant
Description
Maternal attention towards the infant will be video recorded during both laboratory sessions
Time Frame
day 1 and day 8 during lab visits
Title
Changes in breastfeeding mothers' neural activity - Frontal asymmetry
Description
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.
Time Frame
day 1 and day 8 during lab visits
Title
Changes in breastfeeding mothers' neural activity - ERP
Description
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
Time Frame
day 1 and day 8 during lab visits
Title
Changes in breastfeeding mothers' physiological responses - HRV
Description
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).
Time Frame
day 1 and day 8 during lab visits
Title
Changes in breastfeeding mothers' physiological responses - Electrodermal activity
Description
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).
Time Frame
day 1 and day 8 during lab visits
Title
Changes in breastfeeding mothers' physiological responses - Cardiograph Impedance
Description
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).
Time Frame
day 1 and day 8 during lab visits
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Healthy breastfeeding mothers
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilanit Gordon, Prof.
Phone
+972 - 3-5317520
Email
ilanit.gordon@biu.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Lilach Graff Nomkin, PhD student
Phone
: +972545445013
Email
lgnomkin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilanit Gordon, Prof.
Organizational Affiliation
Department of Psychology, Gonda Brain Research Center Bar-Ilan University
Official's Role
Study Chair
Facility Information:
Facility Name
Gonda Brain Center, Bar-Ilan University
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilanit Gordon, Prof.
12. IPD Sharing Statement
Learn more about this trial
SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers
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