SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers

NCT06030830 | Unknown

• 1 other identifier: IG30623
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Smartphone Addiction; Breastfeeding; Infant Behavior; Mother-Infant Interaction

Keywords

Smartphone addiction; Problematic smartphone use; Breastfeeding; Infant temperament; Mother-infant interaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Breastfeeding as a rewarding experience

  Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week

• Self-reported maternal attention towards infant

  Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week

• Video recorded maternal attention towards infant

  day 1 and day 8 during lab visits

• Changes in breastfeeding mothers' neural activity - Frontal asymmetry

  day 1 and day 8 during lab visits

• Changes in breastfeeding mothers' neural activity - ERP

  day 1 and day 8 during lab visits

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: SMaRT Mom

Control

NO INTERVENTION

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

Interventions

SMaRT Mom BEHAVIORAL

"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.

Intervention

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Healthy breastfeeding mothers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• months old infant
• Smartphone Addiction Scale' cut-off (31 and above)

You may not qualify if:

• No neurological disorders
• No heart disease
• No anxiety and depression
• No use of psychiatric drugs

Sponsors & Collaborators

• Bar-Ilan University, Israel: lead

Study Sites (1)

Gonda Brain Center, Bar-Ilan University

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Internet Addiction Disorder; Breast Feeding; Infant Behavior

Condition Hierarchy (Ancestors)

Technology Addiction; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Feeding Behavior; Child Behavior

Study Officials

• Ilanit Gordon, Prof.

  Department of Psychology, Gonda Brain Research Center Bar-Ilan University

  STUDY CHAIR

Central Study Contacts

Ilanit Gordon, Prof.

CONTACT

+972 - 3-5317520; ilanit.gordon@biu.ac.il

Lilach Graff Nomkin, PhD student

CONTACT

: +972545445013; lgnomkin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 11, 2023
• Study Start: June 6, 2023
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

IL (1)