Clinical trial NCT06030830: SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers
Official title: SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers - An Intervention Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smartphone Addiction
Breastfeeding
Infant Behavior
Mother-Infant Interaction
Keywords: Smartphone addiction
Problematic smartphone use
Breastfeeding
Infant temperament
Mother-infant interaction
Lead sponsor: Bar-Ilan University, Israel
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Infant temperament
timeFrame: Pre (day 1) and post (day 8) lab visit (before and after intervention/control week)
measure: Maternal self-efficacy
timeFrame: Pre (day 1) and post (day 8) lab visit (before and after intervention/control week)
Secondary outcomes:
measure: Breastfeeding as a rewarding experience
timeFrame: Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week
measure: Self-reported maternal attention towards infant
timeFrame: Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week
measure: Video recorded maternal attention towards infant
timeFrame: day 1 and day 8 during lab visits
measure: Changes in breastfeeding mothers' neural activity - Frontal asymmetry
timeFrame: day 1 and day 8 during lab visits
measure: Changes in breastfeeding mothers' neural activity - ERP
timeFrame: day 1 and day 8 during lab visits
measure: Changes in breastfeeding mothers' physiological responses - HRV
timeFrame: day 1 and day 8 during lab visits
measure: Changes in breastfeeding mothers' physiological responses - Electrodermal activity
timeFrame: day 1 and day 8 during lab visits
measure: Changes in breastfeeding mothers' physiological responses - Cardiograph Impedance
timeFrame: day 1 and day 8 during lab visits
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Gonda Brain Center, Bar-Ilan University
Study officials:
affiliation: Department of Psychology, Gonda Brain Research Center Bar-Ilan University
name: Ilanit Gordon, Prof.
role: STUDY_CHAIR
References: