Smartphone AddictionSMaRTNCT06030830
SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers
A study testing SMaRT Mom in people with Smartphone Addiction and Breastfeeding, run by Bar-Ilan University, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smartphone Addiction, Breastfeeding, Infant Behavior
- What is being tested?
- SMaRT Mom
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Jun 2023to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 3-6 months old infant
- Smartphone Addiction Scale' cut-off (31 and above)
Who cannot join
- No neurological disorders
- No heart disease
- No anxiety and depression
- No use of psychiatric drugs
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Gonda Brain Center, Bar-Ilan University
Ramat Gan
Ilanit Gordon, Prof.
About this study
Official title: SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers - An Intervention Study
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.
- Being tested
- SMaRT Mom
- Keywords
- Smartphone addiction, Problematic smartphone use, Breastfeeding, Infant temperament, Mother-infant interaction
- Medical subject headings
- Internet Addiction Disorder, Breast Feeding, Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMaRT MomBehavioural
"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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will be instructed not to use the smartphone during breastfeeding for a week Receives: Behavioral: SMaRT Mom |
| Control | No intervention | Participants will not be instructed not to use the smartphone during breastfeeding for a week |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Pre (day 1) and post (day 8) lab visit (before and after intervention/control week)
Secondary outcomes (8)
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?")
Measured: 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?")
Measured: 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
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: day 1 and day 8 during lab visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start6 Jun 2023
- Primary completionJul 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smartphone AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bar-Ilan University, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Ilanit gordon, Bar-Ilan University, Israel
- Investigators
- Ilanit Gordon, Prof., Study chair, Department of Psychology, Gonda Brain Research Center Bar-Ilan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030830
- Sponsor's protocol ID
- IG30623
- Acronym
- SMaRT
- Status last verified
- Sep 2023
- First submitted
- 27 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers - An Intervention Study
- ClinicalTrials.gov ID
- NCT06030830
- Acronym / sponsor ID
- SMaRT / IG30623
- Keywords
- Smartphone addiction, Problematic smartphone use, Breastfeeding, Infant temperament, Mother-infant interaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bar-Ilan University, IsraelUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: SMaRT MomParticipants will be instructed not to use the smartphone during breastfeeding for a week |
| Control | No intervention | –Participants will not be instructed not to use the smartphone during breastfeeding for a week |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 3-6 months old infant
- Smartphone Addiction Scale' cut-off (31 and above)
Key exclusion criteria (4 listed)
- No neurological disorders
- No heart disease
- No anxiety and depression
- No use of psychiatric drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
Primary outcome
Infant temperament
Time frame: 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
Time frame: 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
8 secondary outcomes
Breastfeeding as a rewarding experience
Time frame: Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week
Self-reported maternal attention towards infant
Time frame: Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week
Video recorded maternal attention towards infant
Time frame: day 1 and day 8 during lab visits
Changes in breastfeeding mothers' neural activity - Frontal asymmetry
Time frame: day 1 and day 8 during lab visits
Changes in breastfeeding mothers' neural activity - ERP
Time frame: day 1 and day 8 during lab visits
Changes in breastfeeding mothers' physiological responses - HRV
Time frame: day 1 and day 8 during lab visits
Changes in breastfeeding mothers' physiological responses - Electrodermal activity
Time frame: day 1 and day 8 during lab visits
Changes in breastfeeding mothers' physiological responses - Cardiograph Impedance
Time frame: day 1 and day 8 during lab visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilanit Gordon, Prof. study chair
Department of Psychology, Gonda Brain Research Center Bar-Ilan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMaRT Mom in people with Smartphone Addiction and Breastfeeding, run by Bar-Ilan University, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilanit Gordon, Prof. (+972 - 3-5317520, ilanit.gordon@biu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant temperament (time frame: Pre (day 1) and post (day 8) lab visit (before and after intervention/control week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.