SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers

Sponsor

Bar-Ilan University, Israel (Other)

Overall Status

Recruiting

CT.gov ID

NCT06030830

Collaborator

(none)

100

Enrollment

Location

Arms

27.9

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Smartphone Addiction Breastfeeding Infant Behavior Mother-Infant Interaction	Behavioral: SMaRT Mom	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 6, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Participants will be instructed not to use the smartphone during breastfeeding for a week	Behavioral: SMaRT Mom "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.
No Intervention: Control Participants will not be instructed not to use the smartphone during breastfeeding for a week

Arm

Intervention/Treatment

Experimental: Intervention

Participants will be instructed not to use the smartphone during breastfeeding for a week

Behavioral: SMaRT Mom

"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.

No Intervention: Control

Participants will not be instructed not to use the smartphone during breastfeeding for a week

Outcome Measures

Primary Outcome Measures

Infant temperament [Pre (day 1) and post (day 8) lab visit (before and after intervention/control week)]
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 [Pre (day 1) and post (day 8) lab visit (before and after intervention/control week)]
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 [Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week]
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 [Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week]
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 [day 1 and day 8 during lab visits]
Maternal attention towards the infant will be video recorded during both laboratory sessions
Changes in breastfeeding mothers' neural activity - Frontal asymmetry [day 1 and day 8 during lab visits]
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 [day 1 and day 8 during lab visits]
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 [day 1 and day 8 during lab visits]
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 [day 1 and day 8 during lab visits]
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 [day 1 and day 8 during lab visits]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gonda Brain Center, Bar-Ilan University	Ramat Gan		Israel

Sponsors and Collaborators

Bar-Ilan University, Israel

Investigators

Study Chair: Ilanit Gordon, Prof., Department of Psychology, Gonda Brain Research Center Bar-Ilan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Ilanit gordon, prof., Bar-Ilan University, Israel

ClinicalTrials.gov Identifier:

NCT06030830

Other Study ID Numbers:

IG30623

First Posted:

Sep 11, 2023

Last Update Posted:

Sep 11, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Prof. Ilanit gordon, prof., Bar-Ilan University, Israel

Smartphone addiction

Problematic smartphone use

Breastfeeding

Infant temperament

Mother-infant interaction

Additional relevant MeSH terms:

Behavior, Addictive

Internet Addiction Disorder

Study Results

No Results Posted as of Sep 11, 2023